HEALTH TECHNOLOGY ASSESSMENT

VOLUME 19 ISSUE 38 MAY 2015

ISSN 1366-5278

Treatment of childhood anxiety disorder in the

context of maternal anxiety disorder: a randomised
controlled trial and economic analysis

Cathy Creswell, Susan Cruddace, Stephen Gerry, Rachel Gitau,

Emma McIntosh, Jill Mollison, Lynne Murray, Rosamund Shafran,
Alan Stein, Mara Violato, Merryn Voysey, Lucy Willetts,
Nicola Williams, Ly-Mee Yu and Peter J Cooper

DOI 10.3310/hta19380
Treatment of childhood anxiety disorder
in the context of maternal anxiety
disorder: a randomised controlled trial
and economic analysis

Cathy Creswell,1* Susan Cruddace,1 Stephen Gerry,2

Rachel Gitau,1 Emma McIntosh,3 Jill Mollison,4
Lynne Murray,1,5 Rosamund Shafran,6 Alan Stein,7,8
Mara Violato,9,10 Merryn Voysey,4 Lucy Willetts,11
Nicola Williams,2 Ly-Mee Yu4 and Peter J Cooper1,5
1School of Psychology and Clinical Language Sciences, University of Reading,
Reading, UK
2Centre for Statistics in Medicine, University of Oxford, Oxford, UK
3Health Economics and Health Technology Assessment, Institute of Health and

Wellbeing, University of Glasgow, Glasgow, UK

4Nuffield Department of Primary Health Care Sciences, University of Oxford,

Oxford, UK
5Department of Psychology, Stellenbosch University, Stellenbosch, South Africa
6Institute of Child Health, University College London, London, UK
7Department of Psychiatry, University of Oxford, Oxford, UK
8School of Public Health, University of Witwatersrand, Witwatersrand,

South Africa
9Health Economics Research Centre, University of Oxford, Oxford, UK
10National Institute for Health Research Health Protection Research Unit in

Gastrointestinal Infections, University of Oxford, Oxford, UK

11Berkshire Healthcare NHS Foundation Trust, Reading, UK

*Corresponding author

Declared competing interests of authors: Cathy Creswell was supported by a Medical Research Council
Clinician Scientist Fellowship (G0601874).

Published May 2015

DOI: 10.3310/hta19380
This report should be referenced as follows:

Creswell C, Cruddace S, Gerry S, Gitau R, McIntosh E, Mollison J, et al. Treatment of childhood

anxiety disorder in the context of maternal anxiety disorder: a randomised controlled trial and
economic analysis. Health Technol Assess 2015;19(38).

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 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

Abstract

Treatment of childhood anxiety disorder in the context of

maternal anxiety disorder: a randomised controlled trial and
economic analysis

Cathy Creswell,1* Susan Cruddace,1 Stephen Gerry,2 Rachel Gitau,1

Emma McIntosh,3 Jill Mollison,4 Lynne Murray,1,5 Rosamund Shafran,6
Alan Stein,7,8 Mara Violato,9,10 Merryn Voysey,4 Lucy Willetts,11
Nicola Williams,2 Ly-Mee Yu4 and Peter J Cooper1,5
1School of Psychology and Clinical Language Sciences, University of Reading, Reading, UK
2Centre for Statistics in Medicine, University of Oxford, Oxford, UK
3Health Economics and Health Technology Assessment, Institute of Health and Wellbeing,

University of Glasgow, Glasgow, UK

4Nuffield Department of Primary Health Care Sciences, University of Oxford, Oxford, UK
5Department of Psychology, Stellenbosch University, Stellenbosch, South Africa
6Institute of Child Health, University College London, London, UK
7Department of Psychiatry, University of Oxford, Oxford, UK
8School of Public Health, University of Witwatersrand, Witwatersrand, South Africa
9Health Economics Research Centre, University of Oxford, Oxford, UK
10National Institute for Health Research Health Protection Research Unit in Gastrointestinal

Infections, University of Oxford, Oxford, UK

11Berkshire Healthcare NHS Foundation Trust, Reading, UK

*Corresponding author c.creswell@reading.ac.uk

Background: Cognitive–behavioural therapy (CBT) for childhood anxiety disorders is associated with
modest outcomes in the context of parental anxiety disorder.
Objectives: This study evaluated whether or not the outcome of CBT for children with anxiety disorders in
the context of maternal anxiety disorders is improved by the addition of (i) treatment of maternal anxiety
disorders, or (ii) treatment focused on maternal responses. The incremental cost-effectiveness of the
additional treatments was also evaluated.
Design: Participants were randomised to receive (i) child cognitive–behavioural therapy (CCBT); (ii) CCBT
with CBT to target maternal anxiety disorders [CCBT + maternal cognitive–behavioural therapy (MCBT)];
or (iii) CCBT with an intervention to target mother–child interactions (MCIs) (CCBT + MCI).
Setting: A NHS university clinic in Berkshire, UK.
Participants: Two hundred and eleven children with a primary anxiety disorder, whose mothers also had
an anxiety disorder.
Interventions: All families received eight sessions of individual CCBT. Mothers in the CCBT + MCBT arm
also received eight sessions of CBT targeting their own anxiety disorders. Mothers in the MCI arm received
10 sessions targeting maternal parenting cognitions and behaviours. Non-specific interventions were
delivered to balance groups for therapist contact.

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
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addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
Park, Southampton SO16 7NS, UK.
 ABSTRACT

Main outcome measures: Primary clinical outcomes were the child’s primary anxiety disorder status and
degree of improvement at the end of treatment. Follow-up assessments were conducted at 6 and 12 months.
Outcomes in the economic analyses were identified and measured using estimated quality-adjusted life-years
(QALYs). QALYS were combined with treatment, health and social care costs and presented within an
incremental cost–utility analysis framework with associated uncertainty.
Results: MCBT was associated with significant short-term improvement in maternal anxiety; however, after
children had received CCBT, group differences were no longer apparent. CCBT + MCI was associated with
a reduction in maternal overinvolvement and more confident expectations of the child. However, neither
CCBT + MCBT nor CCBT + MCI conferred a significant post-treatment benefit over CCBT in terms of child
anxiety disorder diagnoses [adjusted risk ratio (RR) 1.18, 95% confidence interval (CI) 0.87 to 1.62,
p = 0.29; adjusted RR CCBT + MCI vs. control: adjusted RR 1.22, 95% CI 0.90 to 1.67, p = 0.20,
respectively] or global improvement ratings (adjusted RR 1.25, 95% CI 1.00 to 1.59, p = 0.05; adjusted
RR 1.20, 95% CI 0.95 to 1.53, p = 0.13). CCBT + MCI outperformed CCBT on some secondary outcome
measures. Furthermore, primary economic analyses suggested that, at commonly accepted thresholds of
cost-effectiveness, the probability that CCBT + MCI will be cost-effective in comparison with CCBT
(plus non-specific interventions) is about 75%.
Conclusions: Good outcomes were achieved for children and their mothers across treatment conditions.
There was no evidence of a benefit to child outcome of supplementing CCBT with either intervention
focusing on maternal anxiety disorder or maternal cognitions and behaviours. However, supplementing
CCBT with treatment that targeted maternal cognitions and behaviours represented a cost-effective use of
resources, although the high percentage of missing data on some economic variables is a shortcoming.
Future work should consider whether or not effects of the adjunct interventions are enhanced in particular
contexts. The economic findings highlight the utility of considering the use of a broad range of services
when evaluating interventions with this client group.
Trial registration: Current Controlled Trials ISRCTN19762288.
Funding: This trial was funded by the Medical Research Council (MRC) and Berkshire Healthcare Foundation
Trust and managed by the National Institute for Health Research (NIHR) on behalf of the MRC–NIHR
partnership (09/800/17) and will be published in full in Health Technology Assessment; Vol. 19, No. 38.

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NIHR Journals Library www.journalslibrary.nihr.ac.uk
 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

Contents

List of tables xiii

List of figures xxi

List of abbreviations xxiii

Plain English summary xxv

Scientific summary xxvii

Chapter 1 Introduction 1
Scientific background 1
Parental anxiety disorders are associated with poor treatment outcomes 1
Other mechanisms associated with poor outcomes 1
Implications for optimal treatment outcomes 2
Rationale for the research 2
Aims 2
Research questions 3

Chapter 2 Trial design and methods 5

Study design 5
Ethical approval and research governance 5
Participants 5
Inclusion criteria 5
Exclusion criteria 6
Recruitment procedure 6
Informed consent 6
Randomisation, concealment and blinding 10
Treatment group allocation 10
Child cognitive–behavioural therapy 10
Maternal cognitive–behavioural therapy 11
Mother–child interaction treatment 11
Data collection and management 12
Baseline assessment 12
Follow-up 12
Measures 13
Primary outcomes 13
Secondary outcomes 13
Sample size 16
Statistical analysis 16

Chapter 3 Trial results 17

Patient flow and numbers analysed 17
Baseline data 17
Manipulation checks: effects of the interventions on maternal anxiety and responses 19
Change in maternal anxiety 19
Change in parenting responses 25

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
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addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
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 CONTENTS

Primary outcomes 27
Missing data 27
Unadjusted analyses: primary end points 30
Multiple imputation analyses 31
Per-protocol analysis of primary outcomes at assessment 2 33
Secondary outcomes 34
Severity of child’s primary Anxiety Disorder Interview Schedule diagnosis at
assessment 2 34
Presence of any Anxiety Disorder Interview Schedule anxiety diagnosis in children at
assessment 2 36
Analysis of change in child-reported questionnaire scores at assessment 2 37
Analysis of change in mother-reported child symptoms at assessment 2 38
Analysis of change in teacher-reported questionnaire scores at assessment 2 38
Post-treatment follow-up 39
Child outcomes at 6-month follow-up 39
Child outcomes at 12-month follow-up 45
Secondary research questions 51
Associations between change in maternal anxiety and child anxiety outcomes
immediately post treatment (assessment 2) 51
Associations between change in maternal parenting responses and child
anxiety outcomes 52
Associations between change in maternal anxiety and child anxiety outcomes 6 and
12 months post treatment (assessments 3 and 4) 53
Adverse events 55

Chapter 4 Economic evaluation: cost–utility analysis of treatment of childhood

anxiety disorder in the context of maternal anxiety disorder 57
Introduction 57
Methods 57
Identification and measurement of health and social care resource use 57
Valuation of health and social care resource use 58
Identifying and measuring outcomes: quality-adjusted life-years 58
Reporting and presenting results 59
Results 60
Data completeness 60
Resource use: therapy time 61
Cost of therapy 64
Cost of additional health, personal social and non-NHS services 66
Quality-adjusted life-years 67
Cost–utility analysis 70
Sensitivity analysis 74
Limitations of the data 74
Discussion 74
Conclusions 75

Chapter 5 Discussion and conclusions 77

Summary of findings 77
Economic evaluation 78
Strengths and limitations 78
Interpretation of results 80
Implications for health care 82
Implications for future research 82

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 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

Acknowledgements 83

References 85

Appendix 1 Patient and public involvement 93

Appendix 2 Mother and child anxiety trial study protocol 95

Appendix 3 Health economic measures 119

Appendix 4 Teacher-reported questionnaire 153

Appendix 5 Summary statistics 155

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
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addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
Park, Southampton SO16 7NS, UK.
 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

List of tables
TABLE 1 Overview of design 10

TABLE 2 Observed parenting behaviours 14

TABLE 3 Baseline characteristics by treatment allocation 17

TABLE 4 Presence of pre-treatment ADIS-IV primary diagnosis at assessment 1B

(including missing data) 20

TABLE 5 Presence of pre-treatment ADIS-IV primary diagnosis at assessment 1B 20

TABLE 6 Analysis of mothers’ recovery from pre-treatment ADIS-IV primary

diagnosis at assessment 1B 20

TABLE 7 Presence of any ADIS-IV anxiety diagnosis in mothers at assessment 1B

(including missing data) 21

TABLE 8 Presence of any ADIS-IV anxiety diagnosis in mothers at assessment 1B 21

TABLE 9 Analysis of recovery from any ADIS-IV anxiety diagnosis in mothers at

assessment 1B 21

TABLE 10 Adjusted analysis of change in mothers’ self-report questionnaires at

assessment 1B 22

TABLE 11 Presence of pre-treatment ADIS-IV primary diagnosis at assessment 2

(including missing data) 22

TABLE 12 Presence of pre-treatment ADIS-IV primary diagnosis at assessment 2 23

TABLE 13 Analysis of mothers’ recovery from pre-treatment ADIS-IV primary

diagnosis at assessment 2 23

TABLE 14 Presence of any ADIS-IV anxiety diagnosis in mothers at assessment 2

(including missing data) 23

TABLE 15 Presence of any ADIS-IV anxiety diagnosis in mothers at assessment 2 24

TABLE 16 Analysis of recovery from any ADIS-IV anxiety diagnosis in mothers at

assessment 2 24

TABLE 17 Adjusted analysis of change in mothers’ self-report questionnaires at

assessment 2 25

TABLE 18 Adjusted analyses of behavioural change scores at assessment 2

(ITT analysis) 26

TABLE 19 Adjusted analyses of cognition change scores at assessment 2 (ITT analysis) 27

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
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addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
Park, Southampton SO16 7NS, UK.
 LIST OF TABLES

TABLE 20 Presence of pre-treatment ADIS-C/P primary diagnosis at assessment 2: child 27

TABLE 21 Clinical Global Impression: child – Improvement at assessment 2 28

TABLE 22 Baseline characteristics by whether or not missing ADIS-C/P assessment

at assessment 2 28

TABLE 23 Presence of pre-treatment ADIS-C/P primary diagnosis at assessment 2: child 30

TABLE 24 Clinical Global Impression: child – Improvement at assessment 2 31

TABLE 25 Results for primary end points (unadjusted, adjusted and multiple
imputation analyses) 32

TABLE 26 Presence of pre-treatment ADIS-C/P primary anxiety diagnosis at

assessment 2: child 33

TABLE 27 Analysis of pre-treatment ADIS-C/P primary anxiety diagnosis at

assessment 2: child 33

TABLE 28 Clinical Global Impression: child – Improvement at assessment 2 34

TABLE 29 Analysis of CGI-I at assessment 2 34

TABLE 30 Change in severity of child’s pre-treatment ADIS-C/P primary diagnosis

at assessment 2, frequency (%) 35

TABLE 31 Proportion of children with at least a 2-point reduction in severity of

their pre-treatment ADIS-C/P primary diagnosis at assessment 2 35

TABLE 32 Presence of any ADIS-C/P anxiety diagnosis in children at assessment 2

(including missing data) 36

TABLE 33 Presence of any ADIS-C/P anxiety diagnosis in children at assessment 2 36

TABLE 34 Analysis of recovery from any ADIS-C/P anxiety diagnosis in children at

assessment 2 36

TABLE 35 Adjusted analyses of change in child-reported questionnaires at

assessment 2 (ITT analysis) 37

TABLE 36 Adjusted analyses of change in mother-reported questionnaires at

assessment 2 38

TABLE 37 Adjusted analysis of change in teacher-reported questionnaires at

assessment 2 38

TABLE 38 Presence of pre-treatment ADIS-C/P primary diagnosis at 6 months

post treatment (including missing data) 39

TABLE 39 Presence of pre-treatment ADIS-C/P primary diagnosis at 6 months 39

TABLE 40 Analysis of pre-treatment ADIS-C/P primary anxiety diagnosis at 6 months 39

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NIHR Journals Library www.journalslibrary.nihr.ac.uk
 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

TABLE 41 Clinical Global Impression: child – Improvement at 6 months

(including missing data) 40

TABLE 42 Clinical Global Impression: child – Improvement at 6 months 40

TABLE 43 Analysis of CGI-I at 6 months 40

TABLE 44 Presence of any ADIS-C/P anxiety diagnosis at 6 months (including

missing data) 41

TABLE 45 Presence of any ADIS-C/P anxiety diagnosis at 6 months 41

TABLE 46 Analysis of recovery from any ADIS-C/P anxiety diagnosis at 6 months 41

TABLE 47 Change in severity of child’s pre-treatment ADIS-C/P primary anxiety

diagnosis at 6 months, frequency (%) 42

TABLE 48 Proportion of children with at least a 2-point reduction in severity of

their pre-treatment ADIS-C/P primary anxiety diagnosis at 6 months 42

TABLE 49 Adjusted analysis of change in child-reported questionnaire scores at

6 months 43

TABLE 50 Adjusted analysis of change in mother-reported child symptoms

questionnaire scores at 6 months 44

TABLE 51 Adjusted analysis of change in teacher-reported questionnaire scores

at 6 months 44

TABLE 52 Presence of pre-treatment ADIS-C/P primary diagnosis at 12 months

(including missing data) 45

TABLE 53 Presence of pre-treatment ADIS-C/P primary diagnosis at 12 months 45

TABLE 54 Analysis of pre-treatment ADIS-C/P primary anxiety diagnosis at

12 months 45

TABLE 55 Clinical Global Impression: child – Improvement at 12 months

(including missing data) 46

TABLE 56 Clinical Global Impression: child – Improvement at 12 months 46

TABLE 57 Analysis of CGI-I at 12 months 46

TABLE 58 Presence of any ADIS-C/P anxiety diagnosis at 12 months (including

missing data) 47

TABLE 59 Presence of any ADIS-C/P anxiety diagnosis at 12 months 47

TABLE 60 Analysis of recovery from any ADIS-C/P anxiety diagnosis at 12 months 47

TABLE 61 Change in severity of child’s pre-treatment ADIS-C/P primary anxiety

diagnosis at 12 months, frequency (%) 48

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
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addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
Park, Southampton SO16 7NS, UK.
 LIST OF TABLES

TABLE 62 Proportion of children with at least a 2-point reduction in severity of

their pre-treatment ADIS-C/P primary anxiety diagnosis at 12 months 48

TABLE 63 Adjusted analysis of change in child-reported questionnaire scores at

12 months 49

TABLE 64 Adjusted analysis of change in mother-reported questionnaire scores

at 12 months 50

TABLE 65 Adjusted analysis of change in teacher-reported questionnaire scores

at 12 months 50

TABLE 66 Correlation between child and mother anxiety scores at assessment 1B 51

TABLE 67 Correlation between child and mother anxiety scores at assessment 2 51

TABLE 68 Correlations between child and mother anxiety questionnaire change

scores at assessment 2 51

TABLE 69 Correlation between change in child anxiety scores and change in

mother behavioural change scores (baseline to assessment 2) 52

TABLE 70 Correlation between change in child anxiety scores and change in

mother cognition change scores (baseline to assessment 2) 53

TABLE 71 Correlations between change in child anxiety scores and change in

mother anxiety questionnaire score at 6 months (assessment 3) 53

TABLE 72 Correlations between change in child anxiety scores and change in

mother anxiety questionnaire score at 12 months 53

TABLE 73 Correlation between change in child anxiety scores at 6 and 12 months

and change in mother behavioural change scores (baseline to assessment 2) 54

TABLE 74 Correlation between change in child anxiety scores at 6 and 12 months

and change in mother cognition change scores (baseline to assessment 2) 55

TABLE 75 Correlation between change in child anxiety scores and change in

maternal-reported overprotection at 6 and 12 months 55

TABLE 76 Detailed treatment resource use volumes 61

TABLE 77 Treatment resource use mean differences: CCBT + MCBT vs. CCBT 62

TABLE 78 Treatment resource use mean differences: CCBT + MCI vs. CCBT 63

TABLE 79 Treatment cost mean differences: CCBT + MCBT vs. CCBT 64

TABLE 80 Treatment cost mean differences: CCBT + MCI vs. CCBT 65

TABLE 81 Cost of other health and social care resources and other non-NHS
services: child, mother and overall (available data only) – CCBT + MCBT vs. CCBT 66

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 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

TABLE 82 Cost of other health and social care resources and other non-NHS
services: child, mother and overall (available data only) – CCBT + MCI vs. CCBT 67

TABLE 83 Child EQ-5D utility values and QALYs gained: CCBT + MCBT vs. CCBT 68

TABLE 84 Child EQ-5D utility values and QALYs gained: CCBT + MCI vs. CCBT 68

TABLE 85 Mother EQ-5D utility values and QALYs gained: CCBT + MCBT vs. CCBT 69

TABLE 86 Mother EQ-5D utility values and QALYs gained: CCBT + MCI vs. CCBT 69

TABLE 87 Cost–utility analysis (health service perspective): ITT approach –

CCBT + MCBT vs. CCBT 70

TABLE 88 Cost–utility analysis (health service perspective): ITT approach –

CCBT + MCI vs. CCBT 72

TABLE 89 Unit costs 127

TABLE 90 Health economic data completeness 132

TABLE 91 Response rates of patient-held resource use diaries 133

TABLE 92 Other health and social care resources: child – period between
assessment 1A (baseline) and assessment 1B (mid-treatment) 133

TABLE 93 Other health and social care resources: mother – period between
assessment 1A (baseline) and assessment 1B (mid-treatment) 134

TABLE 94 Consumption of medications: mother and child – period between

assessment 1A (baseline) and assessment 1B (mid-treatment) 134

TABLE 95 Other health and social care resources: child – period between
assessment 1B (mid-treatment) and assessment 2 (post treatment) 135

TABLE 96 Other health and social care resources: mother – period between
assessment 1B (mid-treatment) and assessment 2 (post treatment) 136

TABLE 97 Consumption of medications: mother and child – period between

assessment 1B (mid-treatment) and assessment 2 (post treatment) 136

TABLE 98 Other health and social care resources: child – period between
assessment 2 (post treatment) and assessment 3 (6-month follow-up) 137

TABLE 99 Other health and social care resources: mother – period between
assessment 2 (post treatment) and assessment 3 (6-month follow-up) 138

TABLE 100 Consumption of medications: mother and child – period between

assessment 2 (post treatment) and assessment 3 (6-month follow-up) 138

TABLE 101 Other health and social care resources: child – period between
assessment 3 (6-month follow-up) and assessment 4 (12-month follow-up) 139

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
xvii
addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
Park, Southampton SO16 7NS, UK.
 LIST OF TABLES

TABLE 102 Other health and social care resources: mother – period between
assessment 3 (6-month follow-up) and assessment 4 (12-month follow-up) 140

TABLE 103 Consumption of medications: mother and child – period between

assessment 3 (6-month follow-up) and assessment 4 (12-month follow-up) 140

TABLE 104 Cost of other health and social care resources: child – period between
assessment 1A (baseline) and assessment 1B (mid-treatment) 141

TABLE 105 Cost of other health and social care resources: mother – period
between assessment 1A (baseline) and assessment 1B (mid-treatment) 142

TABLE 106 Cost of other health and social care resources: child – period between
assessment 1B (mid-treatment) and assessment 2 (post treatment) 143

TABLE 107 Cost of other health and social care resources: mother – period
between assessment 1B (mid-treatment) and assessment 2 (post treatment) 143

TABLE 108 Cost of other health and social care resources: child – period between
assessment 2 (post treatment) and assessment 3 (6-month follow-up) 144

TABLE 109 Cost of other health and social care resources: mother – period
between assessment 2 (post treatment) and assessment 3 (6-month follow-up) 145

TABLE 110 Cost of other health and social care resources: child – period between
assessment 3 (6-month follow-up) and assessment 4 (12-month follow-up) 146

TABLE 111 Cost of other health and social care resources: mother – period
between assessment 3 (6-month follow-up) and assessment 4 (12-month
follow-up) 147

TABLE 112 Time off school (days) for the child and time off work and usual
activities (days) for the mother: period between assessment 1A (baseline) and
assessment 1B (mid-treatment) 147

TABLE 113 Time off school (days) for the child and time off work and usual
activities (days) for the mother: period between assessment 1B (mid-treatment)
and assessment 2 (post treatment) 148

TABLE 114 Time off school (days) for the child and time off work and usual
activities (days) for the mother: period between assessment 2 (post treatment)
and assessment 3 (6-month follow-up) 148

TABLE 115 Time off school (days) for the child and time off work and usual
activities (days) for the mother: period between assessment 3 (6-month
follow-up) and assessment 4 (12-month follow-up) 148

TABLE 116 Cost–utility (health service perspective): ITT approach – CCBT + MCBT
vs. CCBT 149

TABLE 117 Cost–utility (health service perspective): ITT approach – CCBT + MCI
vs. CCBT 149

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 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

TABLE 118 Descriptive statistics: SCAS questionnaires 155

TABLE 119 Descriptive statistics: CAIS questionnaires 156

TABLE 120 Descriptive statistics: SDQ conduct questionnaires 157

TABLE 121 Descriptive statistics: SMFQ questionnaires 158

TABLE 122 Summary of behavioural scores at baseline and assessment 2, and the
change from baseline to assessment 2 159

TABLE 123 Summary of mothers’ self-report questionnaires at baseline and

assessment 1B, and change from baseline to assessment 1B 161

TABLE 124 Summary of mothers’ self-report questionnaires at baseline and

assessment 2, and change from baseline to assessment 2 163

TABLE 125 Summary of cognition scores at baseline and assessment 2, and the
change from baseline to assessment 2 164

TABLE 126 Summary of child scores at baseline and assessment 2, and the
change from baseline to assessment 2 166

TABLE 127 Summary of mothers’ questionnaire scores at baseline and

assessment 2, and the change from baseline to assessment 2 167

TABLE 128 Summary of teachers’ questionnaire scores at baseline and

assessment 2, and the change from baseline to assessment 2 169

TABLE 129 Descriptive statistics: SCAS questionnaires post treatment 170

TABLE 130 Descriptive statistics: CAIS questionnaires post treatment 170

TABLE 131 Descriptive statistics: SDQ and SMFQ questionnaires post treatment 171

TABLE 132 Missing data by baseline demographics for different variables 172

TABLE 133 Descriptive statistics: SCAS questionnaires baseline 175

TABLE 134 Descriptive statistics: CAIS questionnaires baseline 175

TABLE 135 Descriptive statistics: SDQ and SMFQ baseline 176

TABLE 136 Summary of child-reported questionnaire scores at baseline,

6 months, and change from baseline to 6 months 177

TABLE 137 Summary of mother- and child-reported questionnaire scores at

baseline, 6 months, and change from baseline to 6 months 178

TABLE 138 Summary of teacher-reported questionnaire scores at baseline,

6 months, and change from baseline to 6 months 180

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
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 LIST OF TABLES

TABLE 139 Summary of child-reported questionnaire scores at baseline,

12 months, and change from baseline to 12 months 181

TABLE 140 Summary of mother- and child-reported questionnaire scores at

baseline, 12 months, and change from baseline to 12 months 182

TABLE 141 Summary of teacher-reported questionnaire scores at baseline,

12 months, and change from baseline to 12 months 184

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 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

List of figures
FIGURE 1 Flow chart outlining recruitment schedule 7

FIGURE 2 Consolidated Standards of Reporting Trials diagram 8

FIGURE 3 Presence of pre-treatment ADIS-C/P child primary diagnosis 30

FIGURE 4 Child CGI-I 31

FIGURE 5 Box plot of change in severity of child’s primary ADIS-C/P diagnosis at

assessment 2 by treatment group 35

FIGURE 6 Box plot of change in severity of child’s pre-treatment ADIS-C/P

primary anxiety diagnosis at 6 months 42

FIGURE 7 Box plot of change in severity of child’s primary ADIS-C/P anxiety

diagnosis at 12 months 48

FIGURE 8 Cost-effectiveness plane showing bootstrapped replicates of the ICER:

CCBT + MCBT vs. CCBT 70

FIGURE 9 Cost-effectiveness acceptability curve showing the probability that the

intervention is cost-effective at different willingness-to-pay thresholds:
CCBT + MCBT vs. CCBT 71

FIGURE 10 Net monetary benefit curve and limit curves: CCBT + MCBT vs. CCBT 71

FIGURE 11 Cost-effectiveness plane showing bootstrapped replicates of the ICER:

CCBT + MCI vs. CCBT 72

FIGURE 12 Cost-effectiveness acceptability curve showing the probability that

the intervention is cost-effective at different willingness-to-pay thresholds:
CCBT + MCI vs. CCBT 73

FIGURE 13 Net monetary benefit curve and limit curves: CCBT + MCI vs. CCBT 73

FIGURE 14 Cost-effectiveness plane showing bootstrapped replicates of the ICER:

ITT analysis – CCBT + MCBT vs. CCBT 150

FIGURE 15 Cost-effectiveness acceptability curve showing the probability that

the intervention is cost-effective at different willingness-to-pay thresholds:
ITT analysis – CCBT + MCBT vs. CCBT 150

FIGURE 16 Net monetary benefit curve and limit curves: ITT analysis –
CCBT + MCBT vs. CCBT 151

FIGURE 17 Cost-effectiveness plane showing bootstrapped replicates of the ICER:

ITT analysis – CCBT + MCI vs. CCBT 151

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
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addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
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 LIST OF FIGURES

FIGURE 18 Cost-effectiveness acceptability curve showing the probability that

the intervention is cost-effective at different willingness-to-pay thresholds:
ITT analysis – CCBT + MCI vs. CCBT 152

FIGURE 19 Net monetary benefit curve and limit curves: ITT analysis –
CCBT + MCI vs. CCBT 152

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 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

List of abbreviations

A&E accident and emergency ITT intention to treat

ADIS-C/P Anxiety Disorder Interview MCBT maternal cognitive–behavioural
Schedule for DSM-IV – child and therapy
parent report
MCI mother–child interaction
ADIS-IV Anxiety Disorder Interview
NDC non-directive counselling
Schedule for DSM-IV
NICE National Institute for Health and
CAIS Child Anxiety Impact Scale
Care Excellence
CAIS-c Child Anxiety Impact Scale –
NMB net monetary benefit
child report
OLS ordinary least squares
CAIS-p Child Anxiety Impact Scale –
parent report PD panic disorder
CAMHS Child and Adolescent Mental PP per protocol
Health Services PSWQ Penn State Worry Questionnaire
CAS-t Child Adjustment to School – QALY quality-adjusted life-year
teacher report
RCT randomised controlled trial
CBT cognitive–behavioural therapy
RPI Retail Price Index
CCBT child cognitive–behavioural therapy
RR risk ratio
CEAC cost-effectiveness acceptability
curve SAD separation anxiety disorder

CGI-I Clinical Global Impression – SCAS Spence Child Anxiety Scale

Improvement SCAS-c Spence Child Anxiety Scale –
CI confidence interval child report

CSR clinical severity rating SCAS-p Spence Child Anxiety Scale –

parent report
CUA cost–utility analysis
SCAS-t Spence Child Anxiety Scale –
DASS-21 Depression Anxiety Stress Scale teacher report
DSM-IV Diagnostic and Statistical Manual SD standard deviation
of Mental Disorders, Fourth Edition
SDQ Strengths and Difficulties
EQ-5D European Quality of Life-5 Questionnaire
Dimensions
SDQ-c Strengths and Difficulties
FH family health Questionnaire – child report
GAD generalised anxiety disorder SDQ-p Strengths and Difficulties
HCHS Hospital and Community Health Questionnaire – parent report
Service SDQ-t Strengths and Difficulties
ICC intraclass correlation Questionnaire – teacher report

ICER incremental cost-effectiveness ratio SES socioeconomic status

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Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
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 LIST OF ABBREVIATIONS

SIAS Social Interaction Anxiety Scale SMFQ-p Short Mood and Feelings
Questionnaire – parent report
SMFQ Short Mood and Feelings
Questionnaire SPS Social Phobia Scale
SMFQ-c Short Mood and Feelings TSC Trial Steering Committee
Questionnaire – child report

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 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

Plain English summary

A nxiety disorders are characterised by a level of fear and avoidance that interferes in day-to-day life.
They are among the most common emotional difficulties experienced by children and present a risk for
ongoing emotional difficulties in later life. A talking therapy called cognitive–behavioural therapy (CBT)
is effective for the treatment of childhood anxiety disorders; however, if parents also have an anxiety
disorder children often do not benefit as much as they should. We set out to establish whether or not
supplementing CBT for the child (child cognitive–behavioural therapy; CCBT) with (i) CBT focused on
maternal anxiety disorders, or (ii) an intervention focused on maternal parenting responses, would lead to
better child treatment outcomes than CCBT alone.

A total of 211 children were randomly allocated to (i) CCBT and CBT for the maternal anxiety disorder
(CCBT + maternal CBT); (ii) CCBT and an intervention focused on how the mother interacted with her child
[CCBT + mother–child interaction (MCI)]; or (iii) CCBT alone.

In terms of children’s anxiety disorder diagnoses, severity and symptoms, there was only limited evidence
that supplementing individual CBT for children with anxiety disorders with either intervention significantly
improved treatment outcomes. However, when the cost and relative benefits of treatment to the child
were taken into account, the intervention focused on the MCI was good value for money compared with
CCBT alone.

These findings suggest that, in the context of maternal anxiety disorders, adding treatment focused on
how mothers respond to their child, but not treatment focused on maternal anxiety disorders, may be a
cost-effective approach to treatment.

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 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

Scientific summary

Background

Anxiety disorders are among the most common psychological disorders in childhood and are associated with
adverse outcomes throughout the life course. Psychological treatments [specifically cognitive–behavioural
therapy, (CBT)] have established effectiveness; however, one group who have not been found to benefit as
much as others are children with anxiety disorders who have a parent who also has an anxiety disorder.

There has been limited consideration of how to improve treatment outcomes for children with anxiety
disorders in the context of parental anxiety disorder. Two trials have delivered CBT for the parental
disorder alongside CBT for the child; however, in both these cases the parental CBT was brief and did not
significantly improve parental anxiety. It remains unclear whether or not successful treatment of parental
anxiety would lead to benefits in child anxiety outcomes following CBT.

An alternative explanation for the relatively poor outcomes for children with anxiety disorders in the
context of parental anxiety is that particular parenting responses (that are more common among highly
anxious parents) may reinforce child anxiety disorder and, thus, militate against good treatment outcomes.
Particular parental responses that have been implicated in the maintenance of child anxiety disorders
include an overprotective parenting style, expressed anxiety when the child faces a challenge, and negative
expectations about the child’s competence and coping.

The aim of the trial was to establish the relative clinical effectiveness and cost-effectiveness of treatments
of (i) maternal anxiety, and (ii) key parenting responses, for children with anxiety disorders who have a
primary-caregiving mother with a current anxiety disorder.

Objectives

This randomised controlled trial (RCT) for child anxiety disorder occurring in the context of maternal anxiety
disorder, set out to address the following principal questions:

1. Is the impact of child cognitive–behavioural therapy (CCBT) enhanced by first providing CBT to the
mother for her own anxiety disorder?
2. Is the impact of CCBT enhanced by the addition of therapeutic measures designed to target maternal
parenting responses?

In addition the following secondary questions were addressed:

i. Is sustained improvement in child anxiety significantly associated with a reduction in maternal anxiety?
ii. Is sustained improvement in child anxiety significantly associated with improvements in maternal
modelling, encouragement, overcontrolling/overprotective behaviour and associated cognitions?

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Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
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 SCIENTIFIC SUMMARY

Methods

We carried out a RCT in which we compared CCBT with (i) CBT focused on the maternal anxiety disorder
in addition to CCBT, and (ii) an intervention focused on promoting positive maternal responses to the
child in addition to CCBT. The randomisation ratio was 1 : 1. The randomisation was carried out with a
remote facsimile system and was minimised for child age, gender, primary anxiety disorder diagnosis, and
baseline severity of the child and the mother’s primary anxiety disorder.

Participants were recruited from referrals to NHS Child and Adolescent Mental Health Services
across Berkshire.

The inclusion criteria for children were age (7–12 years) and primary diagnosis of a current anxiety disorder
according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) (American
Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 4th edn. Washington, DC:
American Psychiatric Association; 2000). The inclusion criteria for mothers were that the mother was the
primary carer and had a current DSM-IV anxiety disorder. Exclusion criteria for children were significant and
intellectual impairment, a current prescription of psychotropic medication that had not been at a stable
dose for at least 1 month and without agreement to maintain a stable dose for the duration of the study,
and previous receipt of six or more sessions of CBT. Exclusion criteria for mothers were significant
intellectual impairment, a severe comorbid disorder (that would interfere with the mothers ability to
participate in treatment sessions), or a current prescription of psychotropic medication that had not been
at a stable dose for at least 1 month and without agreement to maintain a stable dose for the duration of
the study.

The primary outcomes were the number of children who were free of their primary anxiety disorder
diagnosis, and the number who were classified as ‘much’ or ‘very much’ improved on the Clinical Global
Impression – Improvement scale immediately after the treatment phase. Further follow-ups were conducted
6 and 12 months after the end of treatment. Secondary outcomes were the severity of the child’s primary
diagnosis, the number of children who were free of all their anxiety diagnoses, child- and mother-reported
child anxiety symptoms, impact and comorbid symptoms, and teacher-reported anxiety and adjustment
at school.

Outcomes for the economic analyses were identified and measured using quality-adjusted life-years (QALYs),
estimated on the basis of child reports on the European Quality of Life-5 Dimensions at all assessments from
baseline to the 12-month follow-up. Costs associated with each treatment arm were based on patient-level
resource use data, collected as an integral part of the trial data collection process on the basis of mother and
therapist report.

All children received individual CBT over eight weekly sessions. Mothers randomised to the maternal
cognitive–behavioural therapy (MCBT) treatment arm received eight weekly individual CBT sessions focused
on their own difficulties with anxiety. Mothers in the other two arms received a non-specific intervention
[non-directive counselling (NDC)] to balance for therapist contact. Mothers in the CCBT + mother–child
interaction (MCI) arm received 10 therapeutic sessions (over 8 weeks; eight with the mother alone and two
with the mother and child) which were designed to target potentially anxiogenic maternal parenting
behaviours. Those in the other two treatment arms received a non-specific intervention to balance for
therapist contact (family health; FH). All therapists followed written manuals, received regular supervision and
audio-recorded treatment sessions so that adherence to treatment protocols could be evaluated.

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 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

Results

A total of 676 potential participants were assessed for eligibility. Of these, 435 participants did not meet
eligibility criteria (in the majority of cases because the mother did not have a concurrent anxiety disorder)
and 30 eligible families did not give consent to participate. A total of 211 children were randomised,
with 84% assessed at the post-treatment assessment, and 72% and 65% at 6- and 12-month follow-up
assessments, respectively.

At baseline 69 participants were randomised to the MCBT + CCBT arm, 71 participants to MCI + CCBT
and 71 participants to CCBT + non-specific interventions. The three randomised groups were comparable
at baseline. Analysis of audio-recordings of treatment sessions showed that there were no significant
differences in adherence to the CCBT treatment protocol across the three treatment arms. The content of
the targeted and non-specific interventions were significantly different in the case of both MCBT and NDC,
and MCI and FH, in both cases indicating that the content of the treatments differed as intended. There
was also evidence that both the MCBT and MCI interventions were associated with some change in the
variables that they were targeting. Immediately after the MCBT intervention, mothers in the CCBT + MCBT
arm were 1.63 times more likely to have recovered from their primary diagnosis and 2.51 times more likely
to have recovered from all their anxiety diagnoses compared with mothers in the CCBT arm. However,
there were no significant differences on maternal self-report questionnaire scores. Furthermore, by the
later assessment points maternal recovery rates improved for all treatment arms and differences between
arms were no longer significant. In comparison to those in the CCBT arm, mothers who received
CCBT + MCI showed a greater change in observed overprotection and expectations relating to how scared
and in control their child would be compared with the CCBT arm. Significant differences were not found
on any other measures of parenting response.

The primary analysis indicated that, for the number of children free of their primary diagnosis, although the
CCBT + MCBT and CCBT + MCI arms were associated with better outcomes, these were not significantly
different from the CCBT arm [CCBT + MCBT risk ratio (RR) 1.21, 95% confidence interval (CI) 0.86 to 1.71,
p = 0.280; CCBT + MCI vs. CCBT RR 1.24, 95% CI 0.88 to 1.74, p = 0.219]. This was also the case for
the number ‘much’ or ‘very much’ improved (CCBT + MCBT RR 1.24, 95% CI 0.99 to 1.57, p = 0.065;
CCBT + MCI RR 1.18, 95% CI 0.93 to 1.50, p = 0.179). At the 6- and 12-month follow-up assessments
CCBT + MCI (but not CCBT + MCBT) continued to be associated with relatively high recovery rates, but
neither of the groups differed significantly from CCBT. Significantly more children (92%) in the CCBT + MCI
arm, compared with the CCBT arm (73%), showed a reduction in severity of their primary diagnosis 6 months
post treatment [χ2(1) = 6.19; p = 0.013]. A similar pattern was found at the 12-month follow-up; however,
this was not statistically significant. No significant differences were found on child, mother or teacher
between treatment arms at any assessment point.

Analysis of the secondary research questions yielded inconsistent results, both across reporters and
assessment time points. There was not a consistent pattern of association between change in maternal
anxiety or parenting responses and change in child outcomes, so clear conclusions about mechanisms of
change cannot be drawn at this stage.

The economic evaluations suggested that from a health service perspective only, the mean health cost of
the CCBT + MCBT arm was on average £233.55 (95% CI –£6.81 to £473.92) higher than the CCBT arm,
whereas mean child QALY gain was 0.033 (95% CI –0.101 to 0.035) lower. Similarly, incremental
health-care costs in the CCBT + MCI arm were on average £233.16 (95% CI –£6.81 to £473.92) higher than
the CCBT arm, with the child QALY gain 0.028 (95% CI –0.030 to 0.086) higher. The cost-effectiveness
acceptability curve (CEAC) for the CCBT + MCBT arm suggested that, given the distribution of the
incremental cost-effectiveness ratios, CCBT + MCBT is highly unlikely to be cost-effective at current
willingness-to-pay thresholds for an extra QALY (£20,000–30,000) with a probability lower than 0.1. The
CEAC for the CCBT + MCI arm, however, revealed that the probability that CCBT + MCI is cost-effective in
comparison with CCBT alone is around 75%. These results should, however, be interpreted in light of an

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
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addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
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 SCIENTIFIC SUMMARY

important limitation of the data, namely the high percentage of missing values in some of the follow-up
resource use and outcome variables. This shortcoming was dealt with using appropriate data imputation
techniques; however, imputation cannot account for potentially non-random reasons for missing data.

Conclusions

Implications for health care

l The novel intervention that focused on modifying maternal parenting responses was associated with
some benefit to children and mothers with anxiety disorders, and is likely to be cost-effective.
Incorporating effective measures to address maternal cognitions and behaviours when interacting with
her child may improve health outcomes for children with anxiety disorders in the context of maternal
anxiety disorder.
l We can be confident that supplementing individual CCBT with CBT to target the maternal anxiety
disorder is unlikely to confer substantial health benefits and is unlikely to be cost-effective. Given
the intensity of this intervention and its general lack of effectiveness we think it is unlikely that
supplementing CCBT with this intervention will improve child outcomes.

Future research implications

l Given that CCBT alone was sufficient for the majority of patients, it is possible that any benefits
from the MCI and MCBT interventions may be enhanced in particular contexts; for example, in the
context of particular maternal or child anxiety disorders or high levels of severity. Future research that
directly addresses these possibilities is warranted.
l The relatively low level of association between change in maternal anxiety and responses and child
anxiety, may suggest that other factors may account for the modest treatment outcomes typically
found among children with anxiety disorders who have mothers with anxiety disorders (such as genetic
or broader social/environmental factors). Future research is warranted to address these issues.
l The economic evaluation provides insight as to the broad range of services accessed by this client
group, hence it is recommended that future economic evaluations in this area incorporate data
collection on this full range of services in order to capture the full impact of new interventions for this
client group.

Trial registration

This trial is registered as ISRCTN19762288.

Funding

This trial was funded by the Medical Research Council (MRC) and Berkshire Healthcare Foundation Trust
and managed by the National Institute for Health Research (NIHR) on behalf of the MRC–NIHR partnership
(09/800/17) and will be published in full in Health Technology Assessment; Vol. 19, No. 38.

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 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

Chapter 1 Introduction

Scientific background

Anxiety disorders are among the most common psychological disorders in childhood, affecting 2.6–5.2% of
children under the age of 12 years.1,2 These disorders adversely affect children’s functioning in personal, social
and academic domains,3,4 raise the risk for disorders in adolescence and adulthood,5 and carry a substantial
health and social cost.6 Following advances in the development of successful cognitive–behavioural therapies
(CBTs) for adult anxiety disorders,7 CBT for child anxiety disorders has now been developed. Although there is
still some uncertainty over the optimal form of such an intervention, recent systematic reviews of outcome
research indicate that the general CBT approach produces significant therapeutic benefit in this patient group,
with, on average, 59% of anxious children no longer meeting criteria for their primary anxiety disorder
following CBT.8 However, it is clear from these reviews, and from the individual treatment trials, that the
outcome is highly variable, with a significant proportion (40.6%) of patients retaining their anxiety diagnoses
following treatment.8

Parental anxiety disorders are associated with poor treatment outcomes

One way of further improving children’s responses to treatment is to identify predictors of poor outcome
which are amenable to therapeutic change. One of these is parental emotional distress, in particular
parental anxiety disorder, which has been found to be associated with up to a 50% reduction in child
recovery following treatment.6,9–13 This is of great significance given that the rate of anxiety disorder among
the parents of anxious children is raised.14,15 Indeed, in a consecutive series of children referred for
treatment of an anxiety disorder in our clinic, two-thirds of the mothers were found to have a current
Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)16 anxiety disorder (with no
elevated rate of current disorder among the fathers), almost three times the base rate.17

Two studies to date have examined whether or not targeting parental anxiety might benefit child treatment
outcome. Cobham and colleagues9 found that supplementing child cognitive–behavioural therapy (CCBT)
with parent anxiety management was associated with significantly improved diagnostic outcomes for children
with anxiety disorders whose parents had elevated trait anxiety; however, this group did not maintain a
specific benefit from the parent anxiety management treatment at a 3-year follow-up.18 More recently,
Hudson and colleagues19 used a similar design but classified groups according to parental anxiety disorder
status. In this study, CCBT + parent anxiety management did not confer a significant benefit over CCBT post
teatment or at a 6-month follow-up assessment. Notably, both studies administered brief treatments for
parental anxiety which did not have an overall impact on parental anxiety symptoms or disorder. The question
therefore remains open as to whether or not successful treatment of parental anxiety might benefit
child outcome.

Other mechanisms associated with poor outcomes

An alternative possibility is that it might not be parental anxiety, per se, that is prognostically significant for
child response to treatment but, rather, the parenting practices associated with high levels of parental
anxiety that themselves reinforce or maintain the child disorder. Specific parenting responses have been
implicated in the maintenance of child anxiety, in particular an overcontrolling and overprotective parental
style, expressed anxiety when the child is faced with challenge, 20,21 and associated parental cognitions
and expectations about child competence.22 These behaviours are known to obtain significantly more in
anxious than in non-anxious parents of children with anxiety disorder,23,24 as are associated cognitions
characterised by elevated expectations that the child will be frightened and feel out of control in the face
of a challenge.23 Recent studies have suggested that targeting parental anxiety may be pertinent only
insofar as it changes behaviours that are likely to interfere with the child’s treatment.25 These studies
suggest, therefore, that targeting parenting cognitions and behaviours, rather than parental anxiety,

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
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addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
Park, Southampton SO16 7NS, UK.
 INTRODUCTION

may be of most benefit in bringing about improvement in anxious children’s response to treatment in the
context of parental anxiety disorders.

Implications for optimal treatment outcomes

Cognitive–behavioural therapy treatments of child anxiety disorder commonly require the day-to-day
prosecution of treatment regimes to be managed by the parent (e.g. parents are typically required to model
positive responses to fear provoking stimuli and to prompt and reinforce their child’s positive responses), so it
is likely that the parent’s own anxiety and the associated disturbances in parenting responses may militate
against optimal treatment delivery. Although the CBT treatments developed to date for the treatment of child
anxiety do acknowledge the importance of both parental anxiety and parenting,26–29 there has been no
systematic evaluation of an intervention in which both parental anxiety and parenting responses are
specifically addressed. There is, therefore, a need for the development and evaluation of a CBT treatment for
child anxiety disorder in which parental anxiety and associated patterns of parental responses to the child are
systematically targeted.

Rationale for the research

The outcome from CBT for children with anxiety disorders is highly variable. Major factors contributing to this
are likely to be the presence of parental anxiety and associated disturbances in how parents respond to their
children when they are faced with challenges. Where parental anxiety has been addressed in treatment
research,26–29 for several methodological reasons, it has been difficult to assess its contribution to child
outcome. Two studies have systematically targeted parental anxiety in the treatment of child anxiety
disorders. In one,9 child anxiety outcome was better where therapeutic measures to address parental anxiety
symptoms were included, and in the other19 children’s outcomes were not improved. In both cases, as the
treatment did not significantly alter levels of parental anxiety, it remains unclear what aspect of the treatment
effected the clinical improvement in the children. Similarly, where therapeutic measures to address parenting
responses have been included,30 it has not been possible to determine the specific role of such measures in
the complex treatment package employed. A controlled trial in which both factors – treatment of parental
anxiety and measures to alter parenting responses – are systematically varied, would produce data of both
clinical utility and scientific importance. The study was determined on this basis, and there was no patient or
public input at this stage.

Although paternal behaviours are likely to contribute to the maintenance of child anxiety disorder, this
study focused on mothers for the following reasons: (i) it has been suggested that the parental responses
that may promote anxiety among children differ for mothers and fathers;31 (ii) anxiety disorders are more
common among women than men32 and, also, more common among mothers of children with anxiety
disorders than fathers;17 (iii) mothers are most commonly the primary caregiving parent in the study region
and are more likely to attend treatment sessions for their child (e.g. in a recent study in the same region,
98% of parents nominated as primary caregivers in order to attend treatment were mothers33).

Aims

The aim of the trial was to establish the relative clinical effectiveness and cost-effectiveness of treatments
of (i) maternal anxiety and (ii) key maternal parenting responses for children with anxiety disorders who
have a mother with current anxiety disorder.

2
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 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

Research questions

In a randomised controlled trial (RCT) for child anxiety occurring in the context of maternal anxiety, the
principal questions are:

1. Is the impact of CCBT enhanced by first providing CBT to the mother for her own anxiety?
2. Is the impact of CCBT enhanced by the addition of therapeutic measures designed to address
potentially anxiogenic maternal parenting responses?

Secondary questions are:

1. Is sustained improvement in child anxiety significantly associated with a reduction in maternal anxiety?
2. Is sustained improvement in child anxiety significantly associated with improvements in maternal
modelling, encouragement, overcontrolling/overprotective behaviour and associated cognitions?

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Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
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 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

Chapter 2 Trial design and methods

Study design

The trial was set up to evaluate the benefit of supplementing individual CCBT with either treatment of
maternal anxiety disorder or treatment that targeted maternal responses when interacting with her child,
for children with anxiety disorders whose mothers also had a current anxiety disorder. A three-arm trial
was conducted in which children received individual CCBT in all three arms, supplemented by either
CBT for the maternal anxiety disorder [CCBT + maternal cognitive–behavioural therapy (MCBT)] or a
mother–child interaction (MCI) focused intervention. Non-specific interventions were also delivered in all
treatment arms in order to balance therapist contact. The main trial was supplemented with an economic
evaluation to consider the cost-effectiveness of the CCBT and MCI interventions.

Ethical approval and research governance

Ethical approval for the study was given by Berkshire Research Ethics Committee (07/H0505/156) and the
University of Reading Research Ethics Committee (07/48). The trial was registered with the International
Standard Randomised Controlled Trial Register under the reference number 19762288.

Participants

Participants were 211 children, aged 7–12 years [mean age 10.22 years, standard deviation (SD) 1.58],
with a current anxiety disorder, together with their mothers. As noted above, the study focused on
mothers as (i) intergenerational associations for anxiety disorders are most commonly found between
mothers and their children;17 (ii) mothers are most commonly the primary caregivers in the study region;
and (iii) paternal behaviours may have different associations with childhood anxiety.34 Participants were all
referred to Berkshire Child Anxiety Clinic, run jointly by Berkshire Healthcare NHS Foundation Trust and the
University of Reading, by a health or educational professional. Participants were recruited between June
2008 and May 2011, with the last follow-up assessment in February 2013.

Inclusion criteria

Child

i. Age 7–12 years.

ii. Primary diagnosis of DSM-IV generalised anxiety disorder (GAD), social phobia, separation anxiety
disorder (SAD), panic disorder (PD)/agoraphobia or specific phobia (if comorbid with another
anxiety disorder).

Mother

i. Primary carer.
ii. Current maternal DSM-IV anxiety disorder.

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 TRIAL DESIGN AND METHODS

Exclusion criteria
Participants were not eligible if any of the following criteria are met.

Child

i. Significant physical (where it would impede treatment delivery) or intellectual impairment (including
autistic spectrum disorders) (determined by registration with local learning disability services).
ii. Current prescription of psychotropic medication that had not been at a stable dose for at least 1 month
and without agreement to maintain that dose throughout the study.
iii. Previously received six or more sessions of systematically administered CBT for an anxiety disorder.

Mother

i. Significant intellectual impairment (determined by registration with local learning disability services).
ii. Severe comorbid disorder (e.g. severe major depressive disorder, psychosis, substance/alcohol
dependence that would interfere with the mothers ability to participate in treatment).
iii. Prescription of psychotropic medication that had not been at a stable dose for at least 1 month and
without agreement to maintain that dose throughout the study.

If participating mothers were having any ongoing treatment, this did not preclude them from participating
in the trial, but ideally, any psychotherapeutic treatment should have finished prior to initiating this trial.

Six children were recruited to the trial (two in each treatment arm) who were assigned a primary diagnosis
of anxiety disorder not otherwise specified. Following consultation with the trial management team it was
decided to include these children as the anxiety disorder not otherwise specified diagnosis reflected a slight
variation from meeting diagnostic criteria for GAD. One child was recruited to the trial (CCBT + MCI arm)
on the basis of having a primary diagnosis of selective mutism; and in this case the trial management
group agreed to inclusion as the selective mutism was comorbid with, and was considered to be a
manifestation of, social anxiety disorder. Four children were outside the specified age range at the point
of randomisation. One child was 6 years old but was due to turn the age of 7 years before initiating
treatment (CCBT + MCI arm); three turned 13 years of age between the initial assessment
and randomisation.

Recruitment procedure

The recruitment schedule is shown in Figure 1.

Informed consent

Participants were given a complete description of the study orally and in writing prior to written informed
consent being obtained from participating mothers and assent from participating children. As shown in
Figure 2, 676 children were referred and assessed for eligibility. A total of 435 families did not meet the
inclusion criteria (24 children and 311 mothers because they did not meet criteria for a current anxiety
disorder). Assent/consent was not given by 30 families.

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NIHR Journals Library www.journalslibrary.nihr.ac.uk
 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

1. Suspected anxiety disorder in child

2. Child aged 7–12 years
3. Absence of significant physical or intellectual
impairment (including ASD) in child

Assessment by trial assessors

Does child have current anxiety disorder?

Yes No
Does mother have current Refer back to CAMHS with
anxiety disorder? detailed assessment report

Yes No
Invite to take part in trial Treatment as usual (e.g. group CBT)
Does the family agree?

Yes
Trial protocol

FIGURE 1 Flow chart outlining recruitment schedule. ASD, autistic spectrum disorder; CAMHS, Child and Adolescent
Mental Health Services.

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 8
Total Excluded (n = 465)
Assessed for eligibility 1A Not meeting inclusion criteria, n = 435
(n = 676)
Reasons
• Mother no anxiety disorder, n = 311
• Mother other serious mental
health difficulties, n = 7
• Mother not primary care giver, n = 2
• Child outside age range, n = 3
TRIAL DESIGN AND METHODS

Randomised (n = 211) • Child autistic spectrum

disorder, n = 8
• Child other primary diagnosis, n = 80

NIHR Journals Library www.journalslibrary.nihr.ac.uk

• Child attention/behaviour disorder
primary, n = 38
CCBT (n = 71) MCBT (n = 69) MCI (n = 71) • Child mood disorder primary, n = 6
• Child PTSD primary, n = 6
• Child OCD primary, n = 13
• Child no anxiety disorder, n = 24
Not assessed (n = 7) • Child – other, n = 17
Not assessed (n = 4) Not assessed (n = 1)
Reasons
• Mother in other therapy, n = 1 Reasons Reasons
• Mother withdrew – DNA, n = 5 • Mother withdrew – DNA, n = 4 • Withdrew – child improved, n = 1
• Withdrew – child improved, n = 1

Assessment 1B Assessment 1B Assessment 1B

(n = 64, 90%) (n = 65, 94%) (n = 70, 99%)

Not assessed (n = 8) Not assessed (n = 5) Not assessed (n = 8)

Reasons Reasons Reasons

• Withdrew – DNA, treatment • Withdrew – DNA, treatment • Withdrew – DNA, treatment
not complete, n = 5 not complete, n = 1 not complete, n = 6
• Treatment complete but • Treatment complete but • Treatment complete but
declined assessment, n = 3 declined assessment, n = 4 declined assessment, n = 2
 CCBT MCBT MCI

Assessment 2 Assessment 2 Assessment 2

Park, Southampton SO16 7NS, UK.

Primary outcome
DOI: 10.3310/hta19380

(n = 56, 79%) (n = 60, 87%) (n = 62, 87%)

Not assessed (n = 7) Not assessed (n = 7) Not assessed (n = 11)

Reasons Reasons Reasons
• Withdrew – DNA, n = 5 • Withdrew – DNA, n = 4 • Withdrew – DNA, n = 5
• DNA – declined A3 but • DNA – declined A3 but • Withdrew – left country,
completed A4, n = 2 completed A4, n = 3 n =2
• DNA – declined A3 but
completed A4, n = 4

A3 A3 A3
(n = 49, 69%) (n = 53, 77%) (n = 51, 72%)

Not assessed (n = 8) Not assessed (n = 6) Not assessed (n = 9)

Reasons Reasons Reasons
• Withdrew – DNA, n = 7 • Withdrew – DNA, n = 5 • Withdrew – DNA, n = 6
• Lost contact, n = 1 • Lost contact, n = 1 • Withdrew – lost contact,
n =3

A4 A4 A4
(n = 43, 61%) (n = 50, 70%) (n = 46, 65%)

FIGURE 2 Consolidated Standards of Reporting Trials diagram. A3, assessment 3; A4, assessment 4. DNA, did not attend; OCD, obsessive–compulsive disorder;
PTSD, post-traumatic stress disorder.

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Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
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HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

9
 TRIAL DESIGN AND METHODS

Randomisation, concealment and blinding

Participants were randomised to one of three treatment conditions: (i) CCBT; (ii) CCBT plus CBT for
maternal anxiety disorder (CCBT + MCBT); or (iii) CCBT plus treatment focused on the MCI (CCBT + MCI).
Each of the three conditions included non-specific therapeutic interventions to balance the treatment arms
for therapist contact with both children and mothers. These were non-directive counselling (NDC; for
mothers not receiving MCBT, i.e. groups i and iii) and a family health (FH) intervention (for those not
receiving MCI, i.e. groups i and ii), see Table 1.

Randomisation was performed externally at the Centre for Statistics in Medicine (University of Oxford, UK)
on receipt of anonymised participant information by fax. Patients were randomised with a 1 : 1 : 1 ratio and
minimisation was used to ensure balanced allocation across the treatment groups for child age, gender
and type of child anxiety disorder, and baseline severity of the child’s and mother’s primary anxiety
disorder. The trial manager was informed of randomisation and allocated participants to therapists for
treatment. All assessors and coders remained blind to treatment group for the duration of the study.

Treatment group allocation

The order of treatment delivery is shown in Table 1. MCBT/NDC was delivered first, then the CCBT and
MCI/FH interventions were delivered in parallel. Each phase of treatment (MCBT/NDC, CCBT, MCI/FH) was
delivered by a different therapist.

Child cognitive–behavioural therapy

All children, in all treatment arms, received eight 1-hour weekly sessions of individual CBT delivered by 1 of 10
qualified clinical psychologists or cognitive–behaviour therapists (graduate therapists who held postgraduate
certificates/diplomas in CBT), following a manual adapted from the widely used ‘Cool Kids’ programme35
to be used on an individual rather than group basis. Core components of the treatment include
psychoeducation, identification and modification of anxious thoughts, and graded exposure to feared
situations/stimuli. The adaptations involved reducing the number of sessions to eight (from nine) as the
content could be covered more quickly on an individual basis, and altering exercises and practices so that they
worked well on an individual basis using strategies from the ‘Coping Cat’ programme.36 Sessions took place in

TABLE 1 Overview of design

Condition CCBT CCBT + MCBT CCBT + MCI

Assessment 1: pre treatment Diagnostic assessment (mother and child) + laboratory observation of MCI

Treatment 1 NDC (8) MCBT (8) NDC (2)

Assessment 1B: mid-treatment Diagnostic assessment (mother and child)

(number of sessions)

Treatment 2 (number of sessions) CCBT (8) + FH (mother: 2; CCBT (8) + FH (mother: 2; CCBT (8) + MCI (mother: 8;
child + mother: 2) child + mother: 2) child + mother: 2)

Assessment 2: post treatment Diagnostic assessment (mother and child) + laboratory observation of MCI

Assessment 3: 6 months Diagnostic assessment (child)

post treatment
Assessment 4: 12 months Diagnostic assessment (child)
post treatment

Total therapy sessions Mother: 10 Mother: 10 Mother: 10

Child: 8 Child: 8 Child: 8

Child + mother: 2 Child + mother: 2 Child + mother: 2

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 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

the participants’ local Child and Adolescent Mental Health Services (CAMHS), at the University of Reading
Child Anxiety Clinic or within the child’s home. The focus of treatment was on helping children to identify and
challenge negative thinking styles, gradually increase exposure to feared stimuli and develop problem-solving
skills. Mothers were included briefly in giving and receiving feedback at the beginning and end of each session
(for approximately 5 minutes). To ensure therapist adherence to the CCBT treatment manual was equivalent
across condition, 75 treatment sessions (25 from each condition) were rated for adherence to the manual
(in terms of therapist stance, coverage of general and specific content) by blind raters (minimum Bachelor
of Science psychology) trained to acceptable levels of reliability [therapist stance: intraclass correlation
(ICC) = 0.76–76; general content: ICC = 0.73–0.82; specific content: ICC = 0.81–0.89]. Treatment adherence
for CCBT did not differ across the three conditions [therapist stance: F(2,72) = 1.83, p = 0.17; general content:
F(2,72) = 0.80, p = 0.92; specific content: F(2,72) = 0.23, p = 0.80].

Maternal cognitive–behavioural therapy

Maternal cognitive–behavioural therapy consisted of eight 1-hour weekly sessions delivered by one of
seven clinical psychologists or cognitive–behaviour therapists (all supervised by a highly experienced
clinical psychologist who was a British Association of Behavioural & Cognitive Psychotherapies-accredited
cognitive–behaviour therapist) following a manualised transdiagnostic treatment for adult anxiety
disorders.37 A transdiagnostic approach was applied on the basis that mothers presented with various
anxiety disorders; the effectiveness of a transdiagnostic approach to anxiety disorders has been established
in similar contexts.38 This treatment used cognitive–behavioural methods to reverse the putative
maintaining mechanisms identified through individual formulation. Treatment was delivered in the
participants’ local CAMHS, at the University of Reading Child Anxiety Clinic or within the family’s home.

Groups that did not receive MCBT received a non-specific intervention (NDC), in which mothers received a
supportive individual intervention that was not focused specifically on reducing symptoms of anxiety but
involved supportive non-directive listening for clients to facilitate self-reflection and to clarify and focus on
feelings within an accepting, non-judgemental, empathic environment, following the manual of Borkovec and
Costello.39 NDC was provided by one of five qualified counsellors (all accredited by the British Association for
Counselling & Psychotherapy), supervised by a highly experienced counsellor/psychotherapist with senior
British Association for Counselling & Psychotherapy accreditation.39 To ensure fidelity of the two treatments,
the content of therapist utterances from 100 treatment sessions (50 MCBT, 50 NDC) was allocated by
independent raters (psychology graduates), trained to a high level of reliability, to categories considered as
allowed or not allowed within each treatment condition (reliability of proportion of allowable utterances,
MCBT ICC = 0.73; NDC, ICC = 0.73). The proportion of MCBT allowable utterances was significantly higher in
MCBT than in NDC [t(98) = 6.25; p < 0.001] and the proportion of NDC allowable utterances was significantly
higher in NDC than in MCBT [t(98) = 4.40; p < 0.001], indicating that the content of the two treatments
differed as intended. As shown in Table 1, MCBT and NDC were delivered first, before the delivery of CCBT.

Mother–child interaction treatment

The MCI intervention consisted of 10 sessions delivered over 8 weeks by one of seven qualified clinical
psychologists or cognitive–behaviour therapists (supervised by an experienced clinical psychologist): eight
sessions were with the mother alone and two were with the mother and child together. This was a novel
intervention designed to target potentially anxiogenic maternal parenting behaviours. Specifically, it aimed to
enhance maternal autonomy promoting cognitions (such as confidence in her child’s ability to face challenge)
and behaviours and reduce potentially anxiogenic behaviours. This was achieved through a combination
of specific strategies from existing family interventions for childhood anxiety,30,35 with the addition of
video-feedback techniques developed and piloted by the trial investigators.40,41 Sessions took place in the
participants’ local CAMHS, at the University of Reading Child Anxiety Clinic or within the family’s home. The
two mother and child sessions were conducted within the laboratory at the University of Reading, as these
involved the mother and child completing structured tasks which were video-recorded for feedback purposes.

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Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
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 TRIAL DESIGN AND METHODS

To balance therapist contact, those groups that did not receive the MCI intervention received sessions that
focused on the promotion of a healthy lifestyle (see Table 1). A manual was developed for this intervention
that principally focused on following a healthy diet and participating in regular exercise using a number
of worksheets, games and activities based on existing interventions applied within school settings (FH).42–54
The FH intervention was delivered by 1 of 10 therapists [qualified clinical psychologists, cognitive–behaviour
therapists and one psychology graduate (Bachelor of Science) with extensive experience of delivering
behavioural interventions, under supervision of an experienced clinical psychologist (LW)].

Mother–child interaction/FH were delivered in parallel with CCBT for all participants. To ensure treatment
fidelity, raters who were blind to treatment condition rated audio-recordings of 40 therapy sessions on the
degree to which session content focused on the MCI or FH. Inter-rater reliability was excellent (ICC = 0.98).
MCI sessions were rated significantly higher than FH sessions on the degree to which sessions focused on
MCI (Mann–Whitney U-test = 6.01; p < 0.0001), and FH sessions were rated significantly higher on the
degree to which session focused on FH (Mann–Whitney U-test = 5.90; p < 0.0001) indicating that the
content of the two treatments differed as intended.

Data collection and management

Trial data were entered into an International Business Machine Corporation Statistical Package for the
Social Sciences database (IBM SPSS, version 17; IBM Corporation, Armonk, NY, USA) and monitoring and
tracking information was entered onto a Microsoft Access 2003 database (Microsoft Corporation,
Redmond, WA, USA). A range of data validation checks were carried out in Access, SPSS and Stata
Software Release 12 (StataCorp LP, College Station, TX, USA) to minimise erroneous or missing data.

Assessments of maternal anxiety disorder and parenting were made before and immediately following the
interventions. Assessments of child anxiety disorder status and severity were conducted before and
following treatment, as well as at 6 and 12 months after treatment. All assessors were blind to treatment
group allocation throughout the trial.

Baseline assessment

Baseline assessment for the trial comprised diagnostic interviews conducted with children and their
mothers to ascertain whether or not both the child and his/her mother met diagnostic criteria for a current
anxiety disorder. All of the follow-up measures were also administered at baseline. All baseline
assessments were conducted between May 2008 and May 2011.

Follow-up

As shown in Table 1, follow-up data collection was scheduled to take place ‘mid-treatment’ [i.e. after the
initial maternal intervention, MCBT/NDC (assessment 1B)], then ‘post treatment’ [i.e. after the CCBT
and MCI/FH intervention (assessment 2)], and 6 and 12 months from the post-treatment assessment.
Diagnostic assessments were conducted to establish whether or not interventions had successfully altered
maternal anxiety at the ‘mid-treatment’ (1B) and ‘post-treatment’ (2) assessments. To establish whether
or not the interventions had successfully altered maternal responses, observational and parent-reported
measures were administered at the ‘post-treatment’ assessment. Child diagnostic and symptom outcomes
were assessed at all time points.

All follow-up data were collected between September 2008 and February 2013. A flow chart showing all
recruitment and retention is given in Figure 2.

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 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

Measures

Primary outcomes
The primary outcomes were (i) the status of the child’s primary anxiety disorder and (ii) the extent of child
improvement at the post-treatment assessment. This second primary outcome was added to the primary
outcomes identified in the original protocol following its inclusion as the primary outcome in a recent major
multicentre trial for the treatment of anxiety disorders,55 with approval from the Trial Steering Committee (TSC).

Structured diagnostic interviews with children and parents

Children were assigned diagnoses on the basis of the Anxiety Disorder Interview Schedule for DSM-IV
for children, child and parent versions (Anxiety Disorders Interview Schedule – child and parent report;
ADIS-C/P).56 For the ADIS-C/P, as is standard, overall diagnoses and clinical severity ratings (CSRs)
were assigned if the child met diagnostic criteria on the basis of either the child or parent report, and the
higher CSR of the two was taken. Following convention, only those with a CSR of ≥ 4 (moderate
psychopathology) on a scale from 0 (complete absence of psychopathology) to 8 (severe psychopathology)
were considered to meet diagnostic criteria. The assessors, all psychology graduates, were trained to
administer and score the ADIS-C/P through verbal instruction, listening to assessment audio-recordings,
role-play and participating in diagnostic consensus discussions. Each of the assessor’s first 20 interviews
were discussed with a consensus team, led by a consultant clinical psychologist (LW). The assessor and the
consensus team independently allocated diagnoses and CSRs. Once assessors achieved reliability of at least
0.85, they discussed one in six interviews with the consensus team (to prevent rater drift). Reliability for
presence or absence of child diagnosis on the ADIS-C/P was κ = 0.98 (child report) and κ = 0.98 (mother
report), and CSR ICC = 0.99 (child report) and CSR ICC = 0.99 (mother report).

Clinical Global Impression – Improvement scale57

Overall improvement in child anxiety was assessed using the Clinical Global Impression – Improvement
(CGI-I) scale, a 7-point scale from 1 = very much improved to 7 = very much worse; scores of 1 and 2 are
accepted to represent treatment success. Inter-rater reliability was established using the same procedures
as for the ADIS-C/P. Overall mean inter-rater reliability for the assessment team was high (ICC = 0.96).

Secondary outcomes
Maternal anxiety and maternal interactive responses were assessed to establish whether or not MCI and
MCBT effectively changed these factors. Secondary outcomes included (i) the severity of the child’s primary
anxiety diagnosis; (ii) if the child was or was not free of all of their anxiety diagnoses (as assessed by the
ADIS-C/P above); (iii) child- and mother-reported child anxiety symptoms and impact and comorbid
difficulties; and (iv) teacher-reported symptoms of anxiety and adjustment to school at the post-treatment
assessment. Finally, outcomes included all of the primary and secondary measures at the 6- and 12-month
follow-up assessments.

Maternal anxiety disorder

The presence or absence of a current maternal anxiety disorder was assigned on the basis of the ADIS-IV,58
a structured diagnostic assessment designed to assess the presence and severity of DSM-IV anxiety, mood
and somatoform disorders. CSRs for each disorder present are made and range from 0 (not at all severe)
to 8 (extremely severe/distressing). A rating of 4 is considered to be the cut-off for a clinically significant
disorder. Procedures for training assessors and ensuring inter-rater reliability followed those of the ADIS-C/P.
Reliability for presence or absence of maternal diagnosis on the ADIS-IV was κ = 0.97; and for the
CSR ICC = 0.99.

Maternal symptoms of anxiety and depression

The Depression Anxiety Stress Scale (DASS-21)59 was administered to all participating mothers to assess
self-reported symptoms. The DASS-21 has demonstrated good internal consistency and concurrent validity.60
Maternal symptoms of worry were assessed using the Penn State Worry Questionnaire (PSWQ),61 a 16-item
self-report inventory designed to assess the pathological worry characteristic of GAD. Maternal symptoms of

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Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
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 TRIAL DESIGN AND METHODS

social anxiety were also measured using the Social Interaction Anxiety Scale (SIAS) and the Social Phobia
Scale (SPS).62 The SIAS is a 20-item self-report inventory designed to assess anxiety experienced while
interacting with others. The SPS is a 20-item self-report inventory designed to assess fear of scrutiny when
performing a task or being observed by others. Internal reliability for the scales was good across assessment
time points (DASS-21 anxiety α = 0.80–0.87; DASS-21 depression α = 0.90–0.92; PSWQ α = 0.92–0.93;
SIAS α = 0.92–0.93; SPS α = 0.91–0.94).

Maternal parenting and parental expectations

Maternal behaviours in interaction with the child was assessed by laboratory observation under conditions
of mild social, performance and physical threat.23 The social threat task involved the child preparing and
delivering a speech to a research assistant with a hand-held video camera with their mother’s support. The
performance task involved the child attempting difficult tangram puzzles following the procedure of
Hudson and Rapee.63 The physical threat task required children to investigate the content of four chambers
within a mysterious ‘black box’. To account for prior experience, the assessment was modified at the
post-treatment assessment point; for social stress the child was required to present to a panel rather than
a single research assistant, the tangram puzzles were more difficult and the black box was accompanied by
sound effects (e.g. rustling/scratching).

Observers who were blind to treatment condition coded parental behaviours on scales developed by Murray
and colleagues64 and adapted by Creswell and colleagues23 to be suitable for children aged 7–12 years and
for the specific tasks. Ratings were given for each minute of the interaction on 5-point scales (1 = none,
5 = pervasive/strong). As interactions varied somewhat in duration, mean scores for each task were summed
to give total scores across the full range of tasks. For the current study the following behaviours were
considered: maternal expressed anxiety; control (overprotection and intrusiveness); positivity (warmth and
encouragement); promotion of avoidance; and the general quality of the relationship. See Table 2 for a
description of each type of parenting behaviour. For each coder, in each task, a second coder independently
scored a random sample of 25 videotapes. ICCs showed good agreement across all indices (range 0.60–1.00;
mean 72). The constructs of encouragement and warmth overlap and these scales correlated highly
(p = 0.56–0.58) so were combined to form as single measure of ‘positive behaviours’.

Mothers also completed the parental overprotection measure (OP)65 to assess parenting behaviours that
restrict a child’s exposure to perceived threat or harm (e.g. ‘when playing in the park I keep my child
within a close distance of me’). This parent-reported measure has been found to correlate significantly
with observations of parent behaviours,65,66 and has been found to be reliable and valid for children aged
7–12 years.66 Internal consistency was good across the assessment time points (α = 0.87–0.89).

TABLE 2 Observed parenting behaviours

Negative behaviour
Expressed anxiety Modelling of anxiety: anxiety in facial expression (e.g. fearful expression, biting lip), body
movements (e.g. rigid posture, wringing hands), and speech (e.g. rapid, nervous, or inhibited)

Overprotection Initiates emotional and/or practical support that is not required (stroking/kissing/offering
unnecessary help while child manages independently)

Intrusiveness Interferes, verbally or physically, cutting across child behaviour, attempts to take over and
impose own agenda

Promotion of avoidance Actively encourages/supports child avoidance of task (e.g. saying ‘you don’t have to do it’)

Positive behaviour

Encouragement Provides positive motivation to child to engage in the task, showing enthusiasm regarding
(autonomy–promotion) both task and child capacity/efforts

Warmth Affectionate, expresses positive regard for child, both verbally and physically

Quality of relationship Sense of relatedness and mutual engagement between mother and child (e.g. talking,
listening, laughing and joking with each other)

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 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

Maternal expectations were assessed before initiating the challenge tasks. Immediately after receiving the
instructions for each task, mothers were taken to a separate room where they were asked to provide
ratings regarding their child’s response.23 In the current study we were interested in their responses
regarding (a) how their child would feel about doing the task (0 not scared at all, 10 extremely scared);
(b) how they would feel while their child was doing the task (0 not anxious at all, 10 extremely anxious);
(c) how much their child could do about how the task went (0 nothing at all, 10 a lot); and (d) how much
they could do about their child’s feelings and behaviours during the task (0 nothing at all, 10 a lot).
Ratings were combined across the three tasks to represent their expectations across a range of
challenge contexts.

Symptoms of child anxiety

The Spence Child Anxiety Scale (SCAS)29,67 assessed child- and parent-reported child anxiety symptoms.
The child version [Spence Child Anxiety Scale – child report (SCAS-c)] requires children to rate how often
they experience each of 38 anxiety symptoms, presented alongside six positive filler items. The SCAS-c
and Spence Child Anxiety Scale – parent report (SCAS-p) have demonstrated high internal reliability and
concurrent validity with other well-known anxiety measures.29,67

Impact of child anxiety

The Child Anxiety Impact Scale (CAIS) was used to measure the extent to which anxiety interferes in a
child’s life.68 The Child Anxiety Impact Scale – child report (CAIS-c) and Child Anxiety Impact Scale – parent
report (CAIS-p) covers three psychosocial domains (school, social activities and family functioning) and
consists of 34 items, each rated on a 4-point scale to indicate how much anxiety has caused problems
(not at all, just a little, pretty much, very much). The CAIS-c and CAIS-p have demonstrated good reliability
and validity.68,69

Symptoms of child comorbid difficulties

The Short Mood and Feelings Questionnaire (SMFQ)70 assessed child- and parent-reported symptoms of
child low mood. The Short Mood and Feelings Questionnaire – child report (SMFQ-c) and Short Mood and
Feelings Questionnaire – parent report (SMFQ-p) are brief, 13-item measures which require children or
parents to report how often in the past 2 weeks they have experienced a number of symptoms. The
SMFQ-c has demonstrated high internal reliability and concurrent validity with other well-known measures
of symptoms of depression.70 The conduct problems scale from the Strengths and Difficulties Questionnaire
(SDQ)71 was used to assess child- and parent-reported behavioural disturbance. The Strengths and
Difficulties Questionnaire – child report (SDQ-c) and Strengths and Difficulties Questionnaire – parent
report (SDQ-p) are known to have good psychometric properties and scores correlate highly with other
well-known scales.71

Internal reliability for all these scales was good across assessment time points (SCAS-c α = 0.92–0.94;
SCAS-p α = 0.88–0.93; CAIS-p α = 0.69–0.91; SMFQ-c α = 0.89–0.94; SMFQ-p α = 0.90–0.93), with the
exception of the SDQ conduct scales where internal reliability was marginal (SDQ-p α = 0.54–0.68; SDQ-c
α = 0.55–0.69), although this may reflect the relatively low number of items, and the CAIS-c at the
initial assessment (α = 0.52), although for this scale internal reliability was higher at subsequent
assessments (α = 0.88–0.96).

Teacher-reported child symptoms and adjustment

Teacher reports were collected in an attempt to provide an objective assessment of child adjustment in the
school domain before and after treatment. To assess teacher perceptions of child anxiety symptoms they
completed an adapted version of the SCAS (Spence Child Anxiety Scale – teacher report; SCAS-t). This
comprised the 30 items that it was felt that teachers would be in a position to comment on (i.e. removing
items about, for example, sleep, heights, animal fears). Teachers also completed the conduct scale of the
parent/teacher report form of the SDQ (Strengths and Difficulties Questionnaire – teacher report; SDQ-t)71
which comprised five items. Finally, teachers completed a new measure of the child’s adjustment to school
(Child Adjustment to School – teacher report; CAS-t), which focused on avoidance or worry about common

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
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addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
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 TRIAL DESIGN AND METHODS

school-based activities, such as showing things to the class, participating in group activities, speaking to the
teacher. This comprised eight items that were rated on a 3-point scale from 0 (not true) to 2 (certainly true),
see Appendix 4. Internal reliability for all these scales was acceptable across assessment time points (SCAS-t
α = 0.91–0.96; SDQ-t α = 0.64–0.78; CAS-t α = 0.89–0.92).

Sample size

The study was powered to provide 90% power at the 5% (two-sided) significance level to detect a 30%
difference in the proportion of children who recovered from their primary anxiety disorder post treatment
in the CCBT + MCI or CCBT + MCBT conditions compared with the CCBT condition, with an estimated
remission rate for the CCBT group of 40%.9 Although the effects of the non-specific treatment on child
outcomes were not clear, using the 40% remission rate from Cobham and colleagues9 was considered
reasonable to account for the effect of CCBT plus any non-specific intervention, given the substantially
briefer form of CCBT delivered in the current trial.

A difference of 30% in the proportion of anxiety-free children following completion of the treatment was
considered to be the minimum that would be clinically worthwhile taking into account the increased
resources required and change to service delivery that would be required if either of these interventions
were found to be effective and implemented in practice. The required sample size of 56 children per group
was increased to allow for an estimated 20% loss to follow-up. The sample size was estimated as if two
independent trials were conducted, with no adjustment for multiple testing, as recommended by Machin
and colleagues.72

Statistical analysis

A comprehensive statistical analysis plan was prepared before embarking on the analysis. All primary and
secondary analyses, apart from the per-protocol (PP) sensitivity analyses, were conducted on the
intention-to-treat (ITT) population. The primary end points (recovery from primary diagnosis and overall
improvement in anxiety (CGI-I ratings) at post treatment and other binary end points were analysed using
a modified Poisson regression approach with robust error variance adjusting for the minimisation factors
[child age, child gender, type of child anxiety disorder (GAD, social phobia, SAD, other)], baseline severity
of the child’s and the mother’s primary anxiety disorder (ADIS-IV CSR). The modified Poisson regression
approach described by Zou73 is an alternative to logistic regression which allows for estimation of risks
ratios (RRs) rather than odds ratios. Sensitivity analyses of the primary end points included (i) no adjustment
for minimisation criteria; (ii) PP population (this included those participants who had received at least half
of the treatment sessions and had data for the post-treatment assessments, with the exception of one
mother in the MCBT condition who also received the MCI intervention in error, rather than the FH control;
data from this family was also removed for the PP analyses); and (iii) multiple imputation analysis. Missing
data for the primary end points were multiply imputed by chained equations methods.74 All results from
sensitivity analyses were very similar to the primary results. Interim analyses were conducted by the trial
statistician when 156 participants had been recruited following a request from the funders. The interim results
were kept confidential from the trial manager, all assessors, therapists and their supervisors.

Questionnaire scores, maternal behaviours and maternal cognitions were modelled using linear regression
models with the change from baseline as the dependent variable, adjusted for baseline score and
minimisation factors. There were outliers present in some of the regression models; however, these were
reviewed and were not considered to be due to incorrect completion of the questionnaires. Furthermore,
their removal did not change the conclusions from the regression.

All analyses were conducted using Stata software.

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 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

Chapter 3 Trial results

Patient flow and numbers analysed

Patient flow is shown in Figure 2. The number of available participants for each treatment arm were
as follows:

l post treatment: CCBT n = 56 (79%), CCBT + MCBT n = 60 (87%), CCBT + MCI n = 62 (87%)
l 6 months post treatment: CCBT n = 49 (69%), CCBT + MCBT n = 53 (77%), CCBT + MCI n = 51 (72%)
l 12 months post treatment: CCBT n = 43 (61%), CCBT + MCBT n = 50 (70%), CCBT + MCI n = 46 (65%).

Baseline data

Baseline characteristics were well balanced across treatment groups (Table 3).

TABLE 3 Baseline characteristics by treatment allocation

Baseline characteristic Category CCBT, n (%) CCBT + MCBT, n (%) CCBT + MCI, n (%)

Child ethnicity White British 67 (94.4) 58 (84.1) 55 (77.5)

White Irish 1 (1.4) 1 (1.4)

Any other white background 5 (7.2) 7 (9.9)

White and black Caribbean 1 (1.4)

White and black African 1 (1.4)

White and Asian 2 (2.9)

Any other mixed background 1 (1.4)

Indian 1 (1.4)

Pakistani 2 (2.9) 1 (1.4)

Any other Asian background 1 (1.4) 2 (2.8)

Caribbean 1 (1.4)

Any other ethnic group 1 (1.4)

Did not wish to state ethnicity 1 (1.4)

Not recorded 1 (1.4) 1 (1.4)

Child gender Male 34 (47.9) 35 (50.7) 32 (45.1)

Female 37 (52.1) 34 (49.3) 39 (54.9)

Martial status Single, never married 2 (2.8) 5 (7.2) 5 (7.0)

Married (first time) 28 (39.4) 41 (59.4) 38 (53.5)

Remarried 8 (11.3) 3 (4.3) 5 (7.0)

Divorce/separated 21 (29.6) 11 (15.9) 12 (16.9)

Living with partner 11 (15.5) 9 (13.0) 8 (11.3)

Not recorded 1 (1.4) 3 (4.2)

continued

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
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addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
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 TRIAL RESULTS

TABLE 3 Baseline characteristics by treatment allocation (continued )

Baseline characteristic Category CCBT, n (%) CCBT + MCBT, n (%) CCBT + MCI, n (%)

Employment mother Unemployed 21 (29.6) 23 (33.3) 18 (25.4)

Part time 33 (46.5) 33 (47.8) 37 (52.1)

Full time 14 (19.7) 8 (11.6) 13 (18.3)

Not recorded 3 (4.2) 5 (7.2) 3 (4.2)

Employment father Unemployed 1 (1.4) 6 (8.7) 5 (7.0)

Part time 1 (1.4) 1 (1.4)

Full time 50 (70.4) 50 (72.5) 53 (74.6)

NA 5 (7.0) 1 (1.4) 1 (1.4)

Not recorded 15 (21.1) 11 (15.9) 11 (15.5)

Overall SES Higher professional 29 (40.8) 39 (56.5) 38 (53.5)

Other employed 29 (40.8) 16 (23.2) 26 (36.6)

Unemployed 2 (2.8) 1 (1.4)

Not recorded 11 (15.5) 14 (20.3) 6 (8.5)

Mother education School completion 21 (31.3) 11 (17.7) 22 (33.9)

Further education 34 (50.8) 32 (51.6) 27 (41.5)

Higher education 7 (10.5) 12 (19.4) 12 (18.5)

Postgraduate qualification 5 (7.5) 7 (11.3) 4 (6.2)

Father education School completion 17 (34.7) 12 (22.6) 23 (39.7)

Further education 17 (34.7) 20 (37.7) 20 (34.5)

Higher education 9 (18.4) 15 (28.3) 11 (19.0)

Postgraduate qualification 6 (12.2) 6 (11.3) 4 (6.9)

Child ADIS-C/P SAD 19 (26.8) 16 (23.2) 21 (29.6)

primary diagnosis
Social phobia 16 (22.5) 18 (26.1) 14 (19.7)

GAD 22 (31.0) 20 (29.0) 24 (33.8)

Other 14 (19.7) 15 (21.7) 12 (16.9)

Specific phobia 8 (11.3) 11 (15.8) 5 (7.0)

PD without agoraphobia 1 (1.4)

PD with agoraphobia 1 (1.4)

Agoraphobia without PD 3 (4.2) 2 (2.9) 3 (4.2)

Selective mutism 1 (1.4)

Anxiety disorder not 2 (2.8) 2 (2.9) 2 (2.8)

otherwise specified

Child ADIS-C/P primary Moderate 4 6 (8.5) 5 (7.2) 5 (7.0)

diagnosis CSR
Moderate 5 21 (29.6) 19 (27.5) 19 (26.8)

Severe 6 36 (50.7) 37 (53.6) 40 (56.3)

Severe 7 8 (11.3) 8 (11.6) 7 (9.9)

Child mood disorder No diagnosis 62 (87.3) 62 (89.9) 67 (94.4)

(major depressive
disorder/dysthymia) Diagnosis 9 (12.7) 7 (10.1) 4 (5.6)

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 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

TABLE 3 Baseline characteristics by treatment allocation (continued )

Baseline characteristic Category CCBT, n (%) CCBT + MCBT, n (%) CCBT + MCI, n (%)

Child age (years) 6 1 (1.4)

7 4 (5.6) 5 (7.2) 7 (9.9)

8 12 (16.9) 7 (10.1) 13 (18.3)

9 9 (12.7) 12 (17.4) 12 (16.9)

10 17 (23.9) 17 (24.6) 13 (18.3)

11 18 (25.4) 16 (23.2) 13 (18.3)

12 10 (14.1) 11 (15.9) 11 (15.5)

13 1 (1.4) 2 (2.8)

Mother’s ADIS-IV Specific phobia 12 (16.9) 17 (24.6) 9 (12.7)

primary disorder
GAD 37 (52.1) 35 (50.7) 40 (56.3)

Social phobia 9 (12.7) 14 (20.3) 11 (15.5)

PD 1 (1.4) 1 (1.4)

Agoraphobia 2 (2.8) 1 (1.4) 2 (2.8)

OCD 1 (1.4)

PTSD 1 (1.4)

Major depressive disorder 5 (7.0)

Hypochondriasis 2 (2.8)

Anxiety disorder not 1 (1.4) 2 (2.9) 8 (11.3)

otherwise specified

Mother ADIS-IV CSR of Moderate 4 20 (28.2) 18 (26.1) 18 (25.4)

primary disorder
Moderate 5 22 (31.0) 25 (36.2) 21 (29.6)

Severe 6 22 (31.0) 22 (31.9) 24 (33.8)

Severe 7 6 (8.5) 4 (5.8) 8 (11.3)

Very severe 8 1 (1.4)

Mother mood disorder No diagnosis 57 (80.3) 58 (84.1) 56 (78.9)
(major depressive
disorder/dysthymia) Diagnosis 14 (19.7) 11 (15.9) 15 (21.1)

NA, not applicable; OCD, obsessive–compulsive disorder; PTSD, post-traumatic stress disorder; SES, socioeconomic status.

Manipulation checks: effects of the interventions on maternal

anxiety and responses

Manipulation checks were conducted to evaluate whether or not the MCBT and MCI interventions
successfully altered maternal anxiety and maternal responses, respectively.

Change in maternal anxiety

Recovery from maternal primary diagnosis at assessment 1B

As shown in Table 4, from the CCBT group eight mothers had missing data for their primary ADIS-IV
diagnosis at the mid-treatment assessment (assessment 1B, i.e. after the MCBT intervention), for the
CCBT + MCBT group this was four mothers and for CCBT + MCI this was one mother.

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
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addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
Park, Southampton SO16 7NS, UK.
 TRIAL RESULTS

TABLE 4 Presence of pre-treatment ADIS-IV primary diagnosis at assessment 1B (including missing data)

Treatment allocation Missing, n (%) No diagnosis, n (%) Diagnosis, n (%) Total, n (%)

CCBT 8 (11.3) 23 (32.4) 40 (56.3) 71

CCBT + MCBT 4 (5.8) 38 (55.1) 27 (39.1) 69

CCBT + MCI 1 (1.4) 30 (42.3) 40 (56.3) 71

Total 13 91 107 211

As shown in Table 5, at assessment 1B, 23 mothers (37%) in the control group had recovered from their
primary diagnosis. In the CCBT + MCBT group 38 mothers (59%) had recovered and in the CCBT + MCI
group 30 mothers (43%) had recovered.

Mothers in the CCBT + MCBT group were 1.63 times more likely to recover from their ADIS-IV primary
diagnosis by assessment 1B than those in the CCBT group [adjusted RR 1.63, 95% confidence interval (CI)
1.13 to 2.36; p = 0.009]. The adjusted RR for CCBT + MCI versus CCBT is 1.22 (95% CI 0.83 to 1.81;
p = 0.314) (Table 6).

Recovery from all anxiety diagnoses at assessment 1B

As shown in Table 7, the CCBT group had the largest per cent of missing data for mothers at assessment
1B with 13%, the CCBT + MCBT group had 6% and the CCBT + MCI group had 1%.

As shown in Table 8, in the CCBT group 10 mothers (16%) had recovered from all anxiety diagnoses by
assessment 1B. However, in the CCBT + MCBT group there were 25 recovered mothers (39%) and in the
CCBT + MCI group there were 22 recovered mothers (31%).

TABLE 5 Presence of pre-treatment ADIS-IV primary diagnosis at assessment 1B

Treatment allocation No diagnosis, n (%) Diagnosis, n (%) Total, n (%)

CCBT 23 (36.5) 40 (63.5) 63

CCBT + MCBT 38 (58.5) 27 (41.5) 65

CCBT + MCI 30 (42.9) 40 (57.1) 70

Total 91 107 198

TABLE 6 Analysis of mothers’ recovery from pre-treatment ADIS-IV primary diagnosis at assessment 1B

Parameter Adjusted RRa 95% CI p-valueb

Treatment CCBT Ref.

CCBT + MCBT 1.63 1.13 to 2.36 0.009

CCBT + MCI 1.22 0.83 to 1.81 0.314

Ref., reference category.
a Adjusted for child age, child gender, type of child anxiety disorder (GAD, social phobia, SAD, other), baseline severity
(ADIS-C/P CSR) of the child’s primary anxiety disorder and baseline severity (ADIS-IV mother self-report) of the mother’s
primary anxiety disorder.
b Analysis conducted using the modified Poisson regression framework with robust error variance.

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NIHR Journals Library www.journalslibrary.nihr.ac.uk
 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

TABLE 7 Presence of any ADIS-IV anxiety diagnosis in mothers at assessment 1B (including missing data)

Treatment allocation Missing, n (%) No diagnosis, n (%) Diagnosis, n (%) Total, n (%)

CCBT 9 (12.7) 10 (14.1) 52 (73.2) 71

CCBT + MCBT 4 (5.8) 25 (36.2) 40 (58.0) 69

CCBT + MCI 1 (1.4) 22 (31.0) 48 (67.6) 71

Total 14 57 140 211

TABLE 8 Presence of any ADIS-IV anxiety diagnosis in mothers at assessment 1B

Treatment allocation No diagnosis, n (%) Diagnosis, n (%) Total, n (%)

CCBT 10 (16.1) 52 (83.9) 62

CCBT + MCBT 25 (38.5) 40 (61.5) 65

CCBT + MCI 22 (31.4) 48 (68.6) 70

Total 57 140 197

Mothers receiving CCBT + MCBT or CCBT + MCI were more than twice as likely to have recovered from all
anxiety diagnoses by assessment 1B than mothers in the control group CCBT + MCBT (RR 2.51, 95% CI
1.43 to 4.40; p = 0.001) and CCBT + MCI (RR 2.15, 95% CI 1.21 to 3.81; p = 0.009) (Table 9).

Change in maternal self-reported symptoms at assessment 1B

Table 10 shows the results of analyses looking at the change from baseline to assessment 1B scores of
questionnaires completed by mothers about themselves. There were no significant differences between
treatment groups. Summary scores are shown in Appendix 5, Table 123.

Recovery from maternal primary diagnosis at assessment 2 (end of

all treatment)
As shown in Table 11, missing data was similar at the end of treatment (assessment 2) for mothers in the
CCBT and CCBT + MCBT groups (24% and 20%, respectively). In the CCBT + MCI group it was 13%.

TABLE 9 Analysis of recovery from any ADIS-IV anxiety diagnosis in mothers at assessment 1B

Parameter RRa 95% CI p-valueb

Treatment CCBT Ref.

CCBT + MCBT 2.51 1.43 to 4.40 0.001

CCBT + MCI 2.15 1.21 to 3.81 0.009

Ref., reference category.
a Adjusted for child age, child gender, type of child anxiety disorder (GAD, social phobia, SAD, other), baseline severity
(ADIS-C/P CSR) of the child’s primary anxiety disorder and baseline severity (ADIS-IV mother self-report) of the mother’s
primary anxiety disorder.
b Analysis conducted using the modified Poisson regression framework with robust error variance.

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
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addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
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 TRIAL RESULTS

TABLE 10 Adjusted analysis of change in mothers’ self-report questionnaires at assessment 1B

Adjusteda mean change Adjusteda mean difference

Questionnaire Treatment n (95% CI) (95% CI) p-value

PSWQ total score CCBT 40 –2.91 (–5.91 to 0.10) Ref.

CCBT + MCBT 42 –4.96 (–7.90 to –2.01) –2.05 (–6.31 to 2.21) 0.342

CCBT + MCI 44 –3.72 (–6.59 to –0.84) –0.81 (–5.03 to 3.40) 0.704

SIAS total score CCBT 41 –0.86 (–3.37 to 1.66) Ref.

CCBT + MCBT 44 –1.24 (–3.67 to 1.18) –0.39 (–3.92 to 3.15) 0.829

CCBT + MCI 47 –0.49 (–2.84 to 1.86) 0.37 (–3.12 to 3.85) 0.835

SPS total score CCBT 41 –0.77 (–3.19 to 1.64) Ref.

CCBT + MCBT 45 –0.21 (–2.52 to 2.10) 0.56 (–2.81 to 3.94) 0.742

CCBT + MCI 46 0.07 (–2.22 to 2.36) 0.84 (–2.53 to 4.22) 0.622

DASS-21 depression CCBT 38 –1.54 (–3.28 to 0.21) Ref.
subscale
CCBT + MCBT 43 –2.11 (–3.74 to –0.49) –0.58 (–3.00 to 1.85) 0.638

CCBT + MCI 45 –1.70 (–3.30 to –0.11) –0.17 (–2.57 to 2.23) 0.890

DASS-21 anxiety CCBT 38 –0.38 (–2.36 to 1.60) Ref.

subscale
CCBT + MCBT 44 –1.95 (–3.79 to –0.11) –1.57 (–4.32 to 1.18) 0.259

CCBT + MCI 45 –1.99 (–3.81 to –0.18) –1.61 (–4.34 to 1.10) 0.243

DASS-21 stress CCBT 41 –0.90 (–2.88 to 1.08) Ref.

subscale
CCBT + MCBT 45 –1.76 (–3.65 to 0.13) –0.86 (–3.63 to 1.91) 0.539

CCBT + MCI 45 –1.28 (–3.18 to 0.61) –0.38 (–3.16 to 2.40) 0.786

Ref., reference category.
a Adjusted for child age, child gender, type of child anxiety disorder (GAD, social phobia, SAD, other), baseline severity
(ADIS-C/P CSR) of the child’s primary anxiety disorder, baseline severity (ADIS-IV mother self-report) of the mother’s
primary anxiety disorder and baseline questionnaire score.

TABLE 11 Presence of pre-treatment ADIS-IV primary diagnosis at assessment 2 (including missing data)

Treatment allocation Missing, n (%) No diagnosis, n (%) Diagnosis, n (%) Total, n (%)

CCBT 17 (23.9) 28 (39.4) 26 (36.6) 71

CCBT + MCBT 14 (20.3) 36 (52.2) 19 (27.5) 69

CCBT + MCI 9 (12.7) 41 (57.8) 21 (29.6) 71

Total 40 105 66 211

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 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

As shown in Table 12, there were 36 mothers (66%) in the MCBT group and 41 mothers (66%) in the
CCBT + MCI group who recovered from their primary diagnosis by assessment 2 compared with
28 mothers (52%) from the CCBT group.

The results from log-linear regression of the mothers’ recovery from their primary ADIS-IV diagnosis by
assessment 2, adjusted for minimisation factors, are shown in Table 13. There were no significant
differences between CCBT + MCBT and CCBT or between CCBT + MCI and CCBT. The adjusted RR for the
effect of CCBT + MCBT on recovery from maternal primary diagnosis was 1.23 (95% CI 0.90 to 1.68;
p = 0.201). Similarly, the adjusted RR for the effect of CCBT + MCI on recovery was 1.27 (95% CI 0.93 to
1.74; p = 0.126).

Recovery from all anxiety diagnoses at assessment 2

Missing data was similar at assessment 2 for mothers in the CCBT and CCBT + MCBT groups (24% and
20%, respectively). In the CCBT + MCI group it was 13% (Table 14).

TABLE 12 Presence of pre-treatment ADIS-IV primary diagnosis at assessment 2

Treatment allocation No diagnosis, n (%) Diagnosis, n (%) Total, n (%)

CCBT 28 (51.9) 26 (48.1) 54

CCBT + MCBT 36 (65.5) 19 (34.5) 55

CCBT + MCI 41 (66.1) 21 (33.9) 62

Total 105 66 171

TABLE 13 Analysis of mothers’ recovery from pre-treatment ADIS-IV primary diagnosis at assessment 2

Parameter Adjusted RRa 95% CI p-valueb

Treatment CCBT Ref.

CCBT + MCBT 1.23 0.90 to 1.68 0.201

CCBT + MCI 1.27 0.93 to 1.74 0.126

Ref., reference category.
a Adjusted for child age, child gender, type of child anxiety disorder (GAD, social phobia, SAD, other), baseline severity
(ADIS-C/P CSR) of the child’s primary anxiety disorder and baseline severity (ADIS-IV mother self-report) of the mother’s
primary anxiety disorder.
b Analysis conducted using the modified Poisson regression framework with robust error variance.

TABLE 14 Presence of any ADIS-IV anxiety diagnosis in mothers at assessment 2 (including missing data)

Treatment allocation Missing, n (%) No diagnosis, n (%) Diagnosis, n (%) Total, n (%)

CCBT 17 (23.9) 19 (26.8) 35 (49.3) 71

CCBT + MCBT 14 (20.3) 26 (37.7) 29 (42.0) 69

CCBT + MCI 9 (12.7) 29 (40.9) 33 (46.5) 71

Total 40 74 97 211

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
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addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
Park, Southampton SO16 7NS, UK.
 TRIAL RESULTS

As can be seen in Table 15, 29 mothers (47%) in the CCBT + MCI group had recovered from all ADIS-IV
anxiety diagnoses at assessment 2 and 26 (47%) from the CCBT + MCBT group. Nineteen mothers (35%)
had fully recovered from the CCBT group.

Table 16 shows the results from log-binomial regression of the mothers’ recovery from all ADIS-IV anxiety
diagnoses adjusted for minimisation factors. There were no significant improvements for the CCBT + MCBT
group (RR 1.32, 95% CI 0.85 to 2.04; p = 0.210) or the CCBT + MCI group (RR 1.35, 95% CI 0.87 to
2.10; p = 0.179).

Change in maternal self-reported symptoms at assessment 2

The regression results from the change in mothers’ self-report questionnaires can be seen in Table 17.
There were no significant differences between the CCBT + MCBT and CCBT groups or between the
CCBT + MCI and CCBT groups.

TABLE 15 Presence of any ADIS-IV anxiety diagnosis in mothers at assessment 2

Treatment allocation No diagnosis, n (%) Diagnosis, n (%) Total, n (%)

CCBT 19 (35.2) 35 (64.8) 54

CCBT + MCBT 26 (47.3) 29 (52.7) 55

CCBT + MCI 29 (46.8) 33 (53.2) 62

Total 74 97 171

TABLE 16 Analysis of recovery from any ADIS-IV anxiety diagnosis in mothers at assessment 2

Parameter RRa 95% CI p-valueb

Treatment CCBT Ref.

CCBT + MCBT 1.30 0.84 to 2.01 0.244

CCBT + MCI 1.35 0.87 to 2.10 0.180

Ref., reference category.
a Adjusted for child age, child gender, type of child anxiety disorder (GAD, social phobia, SAD, other), baseline severity
(ADIS-C/P CSR) of the child’s primary anxiety disorder and baseline severity (ADIS-IV mother self-report) of the mother’s
primary anxiety disorder.
b Analysis conducted using the modified Poisson regression framework with robust error variance.

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 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

TABLE 17 Adjusted analysis of change in mothers’ self-report questionnaires at assessment 2

Adjusteda mean change Adjusteda mean difference

Questionnaire Treatment n (95% CI) (95% CI) p-value

PSWQ total score CCBT 35 –7.14 (–10.67 to –3.60) Ref.

CCBT + MCBT 41 –6.71 (–10.00 to –3.42) 0.43 (–4.47 to 5.32) 0.863

CCBT + MCI 35 –6.43 (–10.01 to –2.86) 0.70 (–4.40 to 5.81) 0.785

SIAS total score CCBT 34 –3.52 (–6.77 to –0.27) Ref.

CCBT + MCBT 40 –4.80 (–7.82 to –1.79) –1.28 (–5.79 to 3.22) 0.574

CCBT + MCI 36 –4.75 (–7.93 to –1.58) –1.23 (–5.84 to 3.37) 0.597

SPS total score CCBT 35 –3.91 (–6.15 to –1.67) Ref.

CCBT + MCBT 41 –4.03 (–6.12 to –1.94) –0.12 (–3.24 to 2.99) 0.937

CCBT + MCI 36 –2.20 (–4.65 to –2.16) 1.71 (–1.49 to 4.91) 0.291

DASS-21 depression CCBT 32 –2.83 (–5.11 to –0.55) Ref.
subscale
CCBT + MCBT 36 –3.89 (–6.05 to –1.73) –1.06 (–4.24 to 2.13) 0.511

CCBT + MCI 33 –2.59 (–4.87 to –0.31) 0.24 (–3.05 to 3.54) 0.884

DASS-21 anxiety CCBT 32 –0.62 (–2.80 to 1.57) Ref.

subscale
CCBT + MCBT 36 –2.75 (–4.85 to –0.65) –2.13 (–5.21 to 0.94) 0.171

CCBT + MCI 33 –2.40 (–4.61 to –0.19) –1.79 (–4.95 to 1.38) 0.266

DASS-21 stress CCBT 34 –3.60 (–5.82 to –1.39) Ref.

subscale
CCBT + MCBT 41 –2.45 (–4.48 to –0.42) 1.15 (–1.88. 4.19) 0.453

CCBT + MCI 35 –2.77 (–4.98 to –0.56) 0.83 (–2.36 to 4.02) 0.606

Ref., reference category.
a Adjusted for child age, child gender, type of child anxiety disorder (GAD, social phobia, SAD, other), baseline severity
(ADIS-C/P CSR) of the child’s primary anxiety disorder, baseline severity (ADIS-IV mother self-report) of the mother’s
primary anxiety disorder and baseline questionnaire score.

Change in parenting responses

Parenting behaviours
Change in maternal parenting behaviours was analysed using linear regression. Analysis in Table 18 shows
the adjusted mean change from baseline to assessment 2, for each of the seven areas in each treatment
group. The mean score over three tasks is used for each parenting behaviour. The adjusted mean
difference compares the CCBT + MCBT group with CCBT and also the CCBT + MCI group with CCBT.
A summary of scores is given in Appendix 5, Table 122.

The only significant difference was for CCBT + MCI versus CCBT in the ‘overprotection’ scores (p = 0.026).
The difference between the CCBT + MCI and CCBT arms also approached significance for maternal
self-report overprotection (p = 0.057).

Parenting cognitions
Maternal expectations were assessed before the behavioural tasks. These ratings were recorded at baseline
and at assessment 2. The following analysis, shown in Table 19, looks at the change scores from
baseline to assessment 2, analysed using adjusted linear regression.

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
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addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
Park, Southampton SO16 7NS, UK.
 TRIAL RESULTS

TABLE 18 Adjusted analyses of behavioural change scores at assessment 2 (ITT analysis)

Adjusteda mean change Adjusteda mean difference

Questionnaire Treatment n (95% CI) (95% CI) p-value

Positive CCBT 42 0.042 (–0.058 to 0.141) Ref.

behaviour (–)
CCBT + MCBT 45 –0.009 (–0.104 to 0.086) –0.050 (–0.190 to 0.090) 0.478
CCBT + MCI 49 0.067 (–0.024 to 0.158) 0.026 (–0.112 to 0.163) 0.714

Over-protection (+) CCBT 42 –0.016 (–0.036 to 0.005) Ref.

CCBT + MCBT 45 –0.035 (–0.055 to –0.016) –0.020 (–0.048 to 0.009) 0.174

CCBT + MCI 49 –0.048 (–0.066 to –0.029) –0.032 (–0.060 to –0.004) 0.026

Promotion of CCBT 42 –0.019 (–0.045 to 0.007) Ref.

avoidance (+)
CCBT + MCBT 45 –0.024 (–0.049 to 0.001) –0.004 (–0.041 to 0.033) 0.813

CCBT + MCI 49 –0.042 (–0.066 to –0.019) –0.023 (–0.059 to 0.013) 0.207

Intrusiveness (+) CCBT 42 –0.058 (–0.163 to 0.046) Ref.

CCBT + MCBT 45 0.015 (–0.085 to 0.116) 0.074 (–0.074 to 0.221) 0.324

CCBT + MCI 49 –0.108 (–0.205 to –0.012) –0.050 (–0.195 to 0.195) 0.499

Anxiety (+) CCBT 42 –0.005 (–0.106 to 0.097) Ref.

CCBT + MCBT 45 0.034 (–0.063 to 0.132) 0.039 (–0.103 to 0.182) 0.589

CCBT + MCI 49 –0.013 (–0.107 to 0.080) –0.009 (–0.149 to 0.131) 0.901

Quality of CCBT 42 0.023 (–0.074 to 0.121) Ref.

relationship (–)
CCBT + MCBT 45 0.050 (–0.044 to 0.142) 0.026 (–0.111 to 0.163) 0.712

CCBT + MCI 49 0.003 (–0.086 to 0.092) –0.020 (–0.155 to 0.114) 0.763

POI total score ( + ) CCBT 34 –5.83 (–9.07 to –2.59) Ref.

CCBT + MCBT 38 –6.41 (–9.51 to –3.31) –0.58 (–5.06 to 3.89) 0.7974

CCBT + MCI 34 –10.32 (–13.60 to –7.04) –4.49 (–9.12 to 0.14) 0.0573

–, shows that a low score indicates dysfunction and hence an increase indicates an improvement; +, shows that a high
score indicates dysfunction and hence a decrease indicates an improvement; POI, Parent Over-Involvement Questionnaire;
ref., reference category.
a Adjusted for child age, child gender, type of child anxiety disorder (GAD, social phobia, SAD, other), baseline severity
(ADIS-C/P CSR) of the child’s primary anxiety disorder, baseline severity (ADIS-IV mother self-report) of the mother’s
primary anxiety disorder and baseline questionnaire score.

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NIHR Journals Library www.journalslibrary.nihr.ac.uk
 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

TABLE 19 Adjusted analyses of cognition change scores at assessment 2 (ITT analysis)

Adjusteda mean change Adjusteda mean difference

Questionnaire Treatment n (95% CI) (95% CI) p-value

Pre-task ‘child CCBT 40 –0.69 (–1.12 to –0.26) Ref.

scared’ (+)
CCBT + MCBT 45 –1.22 (–1.62 to –0.82) –0.53 (–1.12 to 0.07) 0.083
CCBT + MCI 46 –1.36 (–1.76 to –0.96) –0.67 (–1.26 to –0.07) 0.029

Pre-task ‘mother CCBT 40 –0.87 (–1.32 to –0.42) Ref.

anxious’ (+)
CCBT + MCBT 45 –1.43 (–1.85 to –1.01) –0.56 (–1.18 to 0.07) 0.079

CCBT + MCI 46 –1.43 (–1.85 to –1.02) –0.56 (–1.18 to 0.06) 0.077

Pre-task ‘child in CCBT 40 0.25 (–0.12 to 0.63) Ref.

control’ (–)
CCBT + MCBT 45 0.75 (0.40 to 1.10) 0.50 (–0.03 to 1.02) 0.063

CCBT + MCI 46 0.78 (0.44 to 1.13) 0.53 (0.01 to 1.05) 0.046

Pre-task ‘mother in CCBT 40 –0.28 (–0.80 to 0.23) Ref.
control’ (+/–)
CCBT + MCBT 45 –0.07 (–0.55 to 0.41) 0.21 (–0.51 to 0.93) 0.564

CCBT + MCI 46 –0.08 (–0.55 to 0.39) 0.20 (–0.50 to 0.91) 0.569

–, shows that a low score indicates dysfunction and hence an increase indicates an improvement; +, shows that a high
score indicates dysfunction and hence a decrease indicates an improvement; +/–, shows that it is unclear whether a high
score or a low score indicates dysfunction; ref., reference category.
a Adjusted for child age, child gender, type of child anxiety disorder (GAD, social phobia, SAD, other), baseline severity
(ADIS-C/P CSR) of the child’s primary anxiety disorder, baseline severity (ADIS-IV mother self-report) of the mother’s
primary anxiety disorder and baseline questionnaire score.

For the pre-task ‘scared’ rating and pre-task ‘child in control’ rating there were significant differences
between CCBT + MCI and CCBT (p = 0.029 and p = 0.046, respectively). A summary of mean scores is
provided in Appendix 5, Table 125.

Primary outcomes

Missing data
Nine (13%) participants allocated to CCBT + MCBT and nine (13%) participants allocated to CCBT + MCI
were not able to be measured for the primary end points. These rates of missing data were slightly lower
than for participants allocated to CCBT (21%). Baseline characteristics of participants with or without
missing primary outcomes are given in Tables 20–22.

TABLE 20 Presence of pre-treatment ADIS-C/P primary diagnosis at assessment 2: child

Treatment allocation Missing, n (%) No diagnosis, n (%) Diagnosis, n (%) Total, n (%)

CCBT 15 (21.1) 27 (38.0) 29 (40.9) 71

CCBT + MCBT 9 (13.0) 35 (50.7) 25 (36.2) 69

CCBT + MCI 9 (12.7) 37 (52.1) 25 (35.2) 71

Total 33 99 79 211

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
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addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
Park, Southampton SO16 7NS, UK.
 TRIAL RESULTS

TABLE 21 Clinical Global Impression: child – Improvement at assessment 2

Much/very much Not much/very much

Treatment allocation Missing, n (%) improved, n (%) improved, n (%) Total, n (%)

CCBT 15 (21.1) 36 (50.7) 20 (28.2) 71

CCBT + MCBT 9 (13.0) 48 (69.6) 12 (17.4) 69

CCBT + MCI 9 (12.7) 47 (66.2) 15 (21.1) 71

Total 33 131 47 211

TABLE 22 Baseline characteristics by whether or not missing ADIS-C/P assessment at assessment 2

Assessment 2

Baseline characteristic Category Completed, n (%) Missing, n (%)

Gender Male 84 (83.2) 17 (16.8)

Female 94 (85.5) 16 (14.5)

Marital status Single, never married 7 (58.3) 5 (41.7)

Married (first time) 90 (84.1) 17 (15.9)

Remarried 13 (81.3) 3 (18.8)

Divorce/separated 39 (88.6) 5 (11.4)

Living with partner 25 (89.3) 3 (10.7)

Not recorded 4 (100.0)

Employment mother Unemployed 48 (77.4) 14 (22.6)

Part time 89 (86.4) 14 (13.6)

Full time 30 (85.7) 5 (14.3)

Not recorded 11 (100.0)

Employment father Unemployed 10 (83.3) 2 (16.7)

Part time 2 (100.0)

Full time 128 (83.7) 25 (16.3)

NA 4 (57.1) 3 (42.9)
Not recorded 34 (91.9) 3 (8.1)

Overall SES Higher professional 93 (87.7) 13 (12.3)

Other employed 57 (80.3) 14 (19.7)

Unemployed 3 (100.0)

Not recorded 25 (80.6) 6 (19.4)

ADIS-C/P primary diagnosis (initial assessment) SAD 45 (80.4) 11 (19.6)

Social phobia 42 (87.5) 6 (12.5)

GAD 51 (77.3) 15 (22.7)

Other 40 (97.6) 1 (2.4)

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NIHR Journals Library www.journalslibrary.nihr.ac.uk
 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

TABLE 22 Baseline characteristics by whether or not missing ADIS-C/P assessment at assessment 2 (continued )

Assessment 2

Baseline characteristic Category Completed, n (%) Missing, n (%)

ADIS-C/P primary diagnosis CSR (initial assessment) Moderate 4 12 (75.0) 4 (25.0)

Moderate 5 50 (84.7) 9 (15.3)

Severe 6 97 (85.8) 16 (14.2)

Severe 7 19 (82.6) 4 (17.4)

ADIS-C/P primary diagnosis CSR at assessment 1B No diagnosis 3 (100.0)

Mild 3 6 (100.0)

Moderate 4 25 (92.6) 2 (7.4)

Moderate 5 52 (85.2) 9 (14.8)

Severe 6 86 (91.5) 8 (8.5)

Severe 7 5 (71.4) 2 (28.6)

Very severe 8 1 (100.0)

Not recorded 12 (100.0)

Child age (years) 6 1 (100.0)

7 11 (68.8) 5 (31.3)

8 27 (84.4) 5 (15.6)

9 28 (84.8) 5 (15.2)
10 41 (87.2) 6 (12.8)

11 43 (91.5) 4 (8.5)

12 25 (78.1) 7 (21.9)

13 3 (100.0)
NA, not applicable; SES, socioeconomic status.

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
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addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
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 TRIAL RESULTS

Unadjusted analyses: primary end points

As shown in Table 23 and Figure 3, 48% of the children in the CCBT arm were free of their primary
diagnosis status at assessment 2 compared with 58% of children in the CCBT + MCBT and 60% of
children in the CCBT + MCI arms.

The unadjusted RR for the effect of CCBT + MCBT versus CCBT on recovery from primary ADIS-C/P diagnosis
by assessment 2 was 1.21 (95% CI 0.86 to 1.71; p = 0.280). This was very similar to the unadjusted estimate
of the effect of CCBT + MCI versus CCBT, RR 1.24 (95% CI 0.88 to 1.74; p = 0.219).

The unadjusted RR for the effect of CCBT + MCBT versus CCBT on CGI-I by assessment 2 was 1.24
(95% CI 0.99 to 1.57; p = 0.065) and for the effect of CCBT + MCI versus CCBT the RR was 1.18
(95% CI 0.93 to 1.50; p = 0.179). Frequencies are displayed in Table 24 and Figure 4.

TABLE 23 Presence of pre-treatment ADIS-C/P primary diagnosis at assessment 2: child

Treatment allocation No diagnosis, n (%) Diagnosis, n (%) Total, n (%)

CCBT 27 (48.2) 29 (51.8) 56

CCBT + MCBT 35 (58.3) 25 (41.7) 60

CCBT + MCI 37 (59.7) 25 (40.3) 62

Total 99 79 178

0.8 0.75 0.74

0.72

0.64
0.60 0.60
Proportion with no diagnosis

0.59 0.58
0.6

0.48 8 weeks
16 weeks
0.4 6 months
12 months

0.22
0.2 0.16
0.11

0.0
CCBT CCBT + MCBT CCBT + MCI

FIGURE 3 Presence of pre-treatment ADIS-C/P child primary diagnosis.

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NIHR Journals Library www.journalslibrary.nihr.ac.uk
 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

TABLE 24 Clinical Global Impression: child – Improvement at assessment 2

Much/very much improved, Not much/very much improved,

Treatment allocation n (%) n (%) Total, n (%)

CCBT 36 (64.3) 20 (35.7) 56

CCBT + MCBT 48 (80.0) 12 (20.0) 60

CCBT + MCI 47 (75.8) 15 (24.2) 62

Total 131 47 178

0.88

0.80 0.80 0.80

0.8 0.77 0.77 0.78 0.76
Proportion much/very much improved

0.64

0.6
8 weeks
16 weeks

0.4 6 months
12 months
0.28
0.22 0.21
0.2

0.0
CCBT CCBT + MCBT CCBT + MCI

FIGURE 4 Child CGI-I.

Multiple imputation analyses

Multiple imputations were used to account for missing data for the two primary end points. Twenty
imputed data sets were developed using the Stata ‘ice’ function for multiple imputation with chained
equations. Imputation models were developed using variables for treatment allocation, minimisation
factors [child age, child gender, type of child anxiety disorder (GAD, social phobia, SAD, other), baseline
severity (ADIS-C/P CSR) of the child’s primary anxiety disorder and baseline severity (ADIS-IV mother
self-report) of the mother’s primary anxiety disorder] as well as assessment of ADIS-C/P CSR at assessment
1B, assessment of ADIS-C/P primary diagnosis at assessment 1B, CGI-I at assessment 1B and baseline
mother’s depression (DASS-21 – depression), child depression symptoms (SMFQ-c), child behavioural
problems (SDQ-conduct) and presence of child social phobia.

Results from multiple imputation analyses, which were the primary analyses, along with adjusted RRs are
presented in Table 25. Adjusted analyses for log-binomial regression models did not converge (as is often
the case), therefore the modified Poisson regression framework with robust error variance was used as
specified in the analysis plan, which gives almost identical CIs.

Confidence intervals for all estimates remained similar regardless of the method of analysis.

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
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addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
Park, Southampton SO16 7NS, UK.
 TRIAL RESULTS

TABLE 25 Results for primary end points (unadjusted, adjusted and multiple imputation analyses)

Assessment 2 RRa 95% CI p-value

ADIS-C/P primary diagnostic status: child

Unadjusted

CCBT Ref.
CCBT + MCBT 1.21 0.86 to 1.71 0.280

CCBT + MCI 1.24 0.88 to 1.74 0.219

a
Adjusted

CCBT Ref.

CCBT + MCBT 1.22 0.88 to 1.67 0.228

CCBT + MCI 1.21 0.88 to 1.65 0.243

a
Multiple imputation
CCBT Ref.

CCBT + MCBT 1.18 0.827 to 1.62 0.285

CCBT + MCI 1.22 0.90 to 1.67 0.203

CGI-I: child
Unadjusted
CCBT Ref.

CCBT + MCBT 1.24 0.99 to 1.57 0.065

CCBT + MCI 1.18 0.93 to 1.50 0.179

a
Adjusted

CCBT Ref.

CCBT + MCBT 1.25 0.99 to 1.57 0.058

CCBT + MCI 1.18 0.93 to 1.50 0.173

a
Multiple imputation

CCBT Ref.

CCBT + MCBT 1.26 1.00 to 1.59 0.054

CCBT + MCI 1.20 0.95 to 1.53 0.133

Ref., reference category.
a Adjusted for child age, child gender, type of child anxiety disorder (GAD, social phobia, SAD, other), baseline severity
(ADIS-C/P CSR) of the child’s primary anxiety disorder and baseline severity (ADIS-IV mother self-report) of the mother’s
primary anxiety disorder.

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 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

Per-protocol analysis of primary outcomes at assessment 2

The PP population is a subset of the ITT population and excludes from the analysis participants who were
ineligible or had significant non-compliance.

The CCBT arm PP population contained 58 children, the CCBT + MCBT arm contained 60 children and the
CCBT + MCI arm contained 64 children. This is a total of 182 children in the PP population, whereas
the ITT population contains 211 children.

Table 26 shows for each treatment group the proportion of children who had recovered from their primary
diagnosis by assessment 2; in both the CCBT + MCBT and CCBT + MCI arms this was 59% and in the
CCBT arm it was 49%.

As shown in Table 27, the adjusted RR for the effect of CCBT + MCBT versus CCBT on recovery from
primary ADIS-IV diagnosis by assessment 2 was 1.17 (95% CI 0.85 to 1.62; p = 0.328). This was very
similar to the adjusted estimate of the effect of CCBT + MCI versus CCBT, RR 1.19 (95% CI 0.86 to
1.64; p = 0.288).

The proportion of patients where the CGI-I rating improved by assessment 2 is shown in Table 28; in the
CCBT arm this was 64%, in the CCBT + MCBT arm it was 80% and in the CCBT + MCI arm it was 75%.

As shown in Table 29, the adjusted RR for the effect of CCBT + MCBT versus CCBT on improvement in
CGI-I by assessment 2 was 1.26 (95% CI 0.99 to 1.59); p = 0.056. The adjusted estimate of the effect of
CCBT + MCI versus CCBT was RR 1.18 (95% CI 0.93 to 1.52; p = 0.170).

TABLE 26 Presence of pre-treatment ADIS-C/P primary anxiety diagnosis at assessment 2: child

Treatment allocation No diagnosis, n (%) Diagnosis, n (%) Total, n (%)

CCBT 27 (49.09) 28 (50.91) 55

CCBT + MCBT 33 (58.93) 23 (41.07) 56

CCBT + MCI 36 (59.02) 25 (40.98) 61

Total 96 76 172

TABLE 27 Analysis of pre-treatment ADIS-C/P primary anxiety diagnosis at assessment 2: child

Parameter Adjusted RRa 95% CI p-valueb

Treatment CCBT Ref.

CCBT + MCBT 1.17 0.85 to 1.62 0.328

CCBT + MCI 1.19 0.86 to 1.64 0.288

Ref., reference category.
a Adjusted for child age, child gender, type of child anxiety disorder (GAD, social phobia, SAD, other), baseline severity
(ADIS-C/P CSR) of the child’s primary anxiety disorder and baseline severity (ADIS-IV mother self-report) of the mother’s
primary anxiety disorder.
b Analysis conducted using the modified Poisson regression framework with robust error variance.

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
33
addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
Park, Southampton SO16 7NS, UK.
 TRIAL RESULTS

TABLE 28 Clinical Global Impression: child – Improvement at assessment 2

Much/very much improved, Not much/very much improved,

Treatment allocation n (%) n (%) Total, n (%)

CCBT 35 (63.64) 20 (36.36) 55

CCBT + MCBT 45 (80.36) 11 (19.64) 56

CCBT + MCI 46 (75.41) 15 (24.59) 61

Total 126 46 172

TABLE 29 Analysis of CGI-I at assessment 2

Parameter Adjusted RRa 95% CI p-valueb

Treatment CCBT Ref.

CCBT + MCBT 1.26 0.99 to 1.59 0.056

CCBT + MCI 1.18 0.93 to 1.52 0.170

Ref., reference category.
a Adjusted for child age, child gender, type of child anxiety disorder (GAD, social phobia, SAD, other), baseline severity
(ADIS-C/P CSR) of the child’s primary anxiety disorder and baseline severity (ADIS-IV mother self-report) of the mother’s
primary anxiety disorder.
b Analysis conducted using the modified Poisson regression framework with robust error variance.

Secondary outcomes

Severity of child’s primary Anxiety Disorder Interview Schedule diagnosis at

assessment 2
By assessment 2, 59% of the CCBT arm, 73% of the CCBT + MCBT arm and 73% of the CCBT + MCI arm
children had seen an improvement of at least 2 points (Figure 5 and Tables 30 and 31).

There were no significant differences between CCBT + MCBT and CCBT or between CCBT + MCI and
CCBT (p = 0.101 and 0.118, respectively).

34
NIHR Journals Library www.journalslibrary.nihr.ac.uk
 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

Change in ADIS primary diagnosis severity by 16 weeks

2

–2

–4

–6

–8
CCBT CCBT + MCBT CCBT + MCI

FIGURE 5 Box plot of change in severity of child’s primary ADIS-C/P diagnosis at assessment 2 by treatment group.

TABLE 30 Change in severity of child’s pre-treatment ADIS-C/P primary diagnosis at assessment 2, frequency (%)

Treatment –7 –6 –5 –4 –3 –2 –1 0 1 Total

CCBT 1 (1.8) 9 (16.1) 11 (19.6) 2 (3.6) 4 (7.1) 6 (10.7) 13 (23.2) 9 (16.1) 1 (1.8) 56

CCBT + MCBT 2 (3.3) 14 (23.3) 9 (15.0) 4 (6.7) 4 (6.7) 11 (18.3) 7 (11.7) 8 (13.3) 1 (1.7) 60

CCBT + MCI 2 (3.2) 17 (27.4) 8 (12.9) 4 (6.5) 2 (3.2) 12 (19.4) 14 (22.6) 3 (4.8) 0 (0.0) 62

Total 5 40 28 10 10 29 34 20 2 178

TABLE 31 Proportion of children with at least a 2-point reduction in severity of their pre-treatment ADIS-C/P
primary diagnosis at assessment 2

Treatment n n (%) with a 2 or more point reduction p-valuea

CCBT 56 33 (58.9)

CCBT + MCBT 60 44 (73.3) 0.101

CCBT + MCI 62 45 (72.6) 0.118
a Chi-squared test, comparison with control group.

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
35
addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
Park, Southampton SO16 7NS, UK.
 TRIAL RESULTS

Presence of any Anxiety Disorder Interview Schedule anxiety diagnosis in

children at assessment 2
As shown in Table 32, the proportion of children with missing data was higher in the CCBT arm (21%);
the CCBT + MCBT arm (13%) and the CCBT + MCI arms (13%) were fairly similar.

As can be seen in Table 33, in the CCBT + MCBT and CCBT + MCI arms 18 and 25 children (30% and
40%), respectively, had recovered from all ADIS-C/P anxiety diagnoses at assessment 2. From the CCBT
arm, 16 participants (29%) had fully recovered.

Table 34 shows the results from log-binomial regression of the children’s recovery from all ADIS-C/P
anxiety diagnoses at assessment 2 adjusted for minimisation factors.

The estimated effect of CCBT + MCBT on ADIS-C/P anxiety diagnoses at assessment 2 compared with the
CCBT arm was RR 1.06 (0.63 to 1.78; p = 0.816). For those children receiving CCBT + MCI the adjusted RR
was 1.48 (95% CI 0.92 to 2.37; p = 0.102).

TABLE 32 Presence of any ADIS-C/P anxiety diagnosis in children at assessment 2 (including missing data)

Treatment allocation Missing, n (%) No diagnosis, n (%) Diagnosis, n (%) Total, n (%)

CCBT 15 (21.1) 16 (22.5) 40 (56.3) 71

CCBT + MCBT 9 (13.0) 18 (26.1) 42 (60.9) 69

CCBT + MCI 9 (12.7) 25 (35.2) 37 (52.1) 71

Total 33 59 119 211

TABLE 33 Presence of any ADIS-C/P anxiety diagnosis in children at assessment 2

Treatment allocation No diagnosis, n (%) Diagnosis, n (%) Total, n (%)

CCBT 16 (28.6) 40 (71.4) 56

CCBT + MCBT 18 (30.0) 42 (70.0) 60

CCBT + MCI 25 (40.3) 37 (59.7) 62

Total 59 119 178

TABLE 34 Analysis of recovery from any ADIS-C/P anxiety diagnosis in children at assessment 2

Parameter Adjusted RRa 95% CI p-valueb

Treatment CCBT Ref.

CCBT + MCBT 1.06 0.63 to 1.78 0.816

CCBT + MCI 1.48 0.92 to 2.37 0.102

Ref., reference category.
a Adjusted for child age, child gender, type of child anxiety disorder (GAD, social phobia, SAD, other), baseline severity
(ADIS-C/P CSR) of the child’s primary anxiety disorder and baseline severity (ADIS-IV mother self-report) of the mother’s
primary anxiety disorder.
b Analysis conducted using the modified Poisson regression framework with robust error variance.

36
NIHR Journals Library www.journalslibrary.nihr.ac.uk
 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

Analysis of change in child-reported questionnaire scores at assessment 2

Analyses of questionnaire results were conducted on the change scores from baseline to assessment 2
owing to the skewed distribution of the raw scores at assessment 2. The change scores were more
normally distributed.

The change scores were modelled using linear regression, adjusted for baseline scores and minimisation
factors. There were some outliers in the regression models, but these were not thought to be due to
incorrect completion of the questionnaires. Furthermore, their removal did not change the conclusions
from the regression.

Table 35 shows the adjusted means of the children’s responses in each treatment arm along with the
adjusted mean difference for CCBT + MCBT and CCBT + MCI in comparison with CCBT. For the SCAS-c
a significant difference was seen between CCBT + MCBT and CCBT (p = 0.031), with the CCBT arm seeing
a bigger reduction in total score on average. For the SMFQ-c a significant difference was seen between
CCBT + MCBT and CCBT (p = 0.004) and also CCBT + MCI and CCBT (p = 0.012); in both cases the
difference was in the opposite direction to what was expected, with the CCBT arm seeing a greater
reduction in the children’s scores than the treatment arms.

Appendix 5, Table 126, presents the summary statistics for questionnaire scores at baseline and assessment
2, along with the difference between baseline and assessment 2, for only those participants with data at
both time points who are included in Table 35.

TABLE 35 Adjusted analyses of change in child-reported questionnaires at assessment 2 (ITT analysis)

Adjusteda mean change Adjusteda mean difference

Questionnaire Treatment n (95% CI) (95% CI) p-value

SCAS-c total score CCBT 45 –19.68 (–23.48 to –15.89) Ref.

CCBT + MCBT 46 –13.71 (–17.49 to –9.92) 5.97 (0.54 to 11.41) 0.031

CCBT + MCI 52 –15.73 (–19.27 to –12.19) 3.96 (–1.28 to 9.19) 0.137

CAIS-c total score CCBT 44 –8.19 (–12.10 to –4.28) Ref.

CCBT + MCBT 45 –6.28 (–10.20 to –2.37) 1.91 (–3.73 to 7.55) 0.505

CCBT + MCI 53 –6.49 (–10.05 to –2.93) 1.70 (–3.63 to 7.03) 0.530

SMFQ-c total score CCBT 46 –5.03 (–6.35 to –3.71) Ref.

CCBT + MCBT 47 –2.25 (–3.57 to –0.93) 2.78 (0.88 to 4.68) 0.004

CCBT + MCI 54 –2.70 (–3.92 to –1.48) 2.33 (0.52 to 4.14) 0.012

SDQ-c conduct CCBT 47 –0.61 (–1.08 to –0.14) Ref.

subscale
CCBT + MCBT 47 –0.52 (–1.00 to –0.05) 0.09 (–0.59 to 0.76) 0.803

CCBT + MCI 55 –0.50 (–0.94 to –0.07) 0.10 (–0.54 to 0.75) 0.748

Ref., reference category.
a Adjusted for child age, child gender, type of child anxiety disorder (GAD, social phobia, SAD, other), baseline severity
(ADIS-C/P CSR) of the child’s primary anxiety disorder, baseline severity (ADIS-IV mother self-report) of the mother’s
primary anxiety disorder and baseline questionnaire score.

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
37
addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
Park, Southampton SO16 7NS, UK.
 TRIAL RESULTS

Analysis of change in mother-reported child symptoms at assessment 2

The results from the regression of the mothers’ questionnaires for child symptoms/impact are shown in
Table 36. There were no significant differences seen between the CCBT + MCBT and CCBT or between
CCBT + MCI and CCBT. Appendix 5, Table 127, presents a summary of the descriptive statistics.

Analysis of change in teacher-reported questionnaire scores at assessment 2

The analysis results of the change scores from the teachers’ questionnaires are shown in Table 37. The
numbers of respondents were small and there were no significant differences in any of the comparisons.
Appendix 5, Table 128, presents a summary of the descriptive statistics.

TABLE 36 Adjusted analyses of change in mother-reported questionnaires at assessment 2

Adjusteda mean change Adjusteda mean difference

Questionnaire Treatment n (95% CI) (95% CI) p-value

SCAS-c total score CCBT 36 –18.00 (–21.09 to –14.88) Ref.

CCBT + MCBT 39 –16.77 (–19.75 to –13.78) 1.22 (–3.15 to 5.59) 0.581

CCBT + MCI 38 –18.30 (–21.35 to –15.25) –0.32 (–4.77 to 4.14) 0.888

CAIS-c total score CCBT 33 –10.19 (–12.37 to –8.01) Ref.

CCBT + MCBT 35 –12.95 (–15.09 to –10.80) –2.76 (–5.86 to 0.34) 0.080

CCBT + MCI 31 –10.15 (–12.45 to –7.84) 0.04 (–3.20 to 3.28) 0.980

SMFQ-c total score CCBT 34 –4.60 (–6.03 to –3.18) Ref.

CCBT + MCBT 38 –5.66 (–7.03 to –4.29) –1.06 (–3.07 to 0.96) 0.301

CCBT + MCI 35 –5.64 (–7.07 to –4.22) –1.04 (–3.08 to 1.00) 0.314

SDQ-c conduct CCBT 37 –0.65 (–1.06 to –0.24) Ref.

subscale
CCBT + MCBT 41 –0.74 (–1.12 to –0.35) –0.09 (–0.66 to 0.49) 0.763

CCBT + MCI 40 –0.84 (–1.23 to –0.45) –0.19 (–0.77 to 0.39) 0.515

Ref., reference category.
a Adjusted for child age, child gender, type of child anxiety disorder (GAD, social phobia, SAD, other), baseline severity
(ADIS-C/P CSR) of the child’s primary anxiety disorder, baseline severity (ADIS-IV mother self-report) of the mother’s
primary anxiety disorder and baseline questionnaire score.

TABLE 37 Adjusted analysis of change in teacher-reported questionnaires at assessment 2

Adjusteda mean change Adjusteda mean difference

Questionnaire Treatment n (95% CI) (95% CI) p-value

SCAS-t total score CCBT 7 –4.02 (–11.27 to 3.23) Ref.

CCBT + MCBT 14 –4.94 (–9.90 to 0.03) –0.92 (–10.69 to 8.85) 0.847

CCBT + MCI 12 –5.31 (–10.53 to –0.10) –1.29 (–10.86 to 8.27) 0.782

CAS-t total score CCBT 18 –0.86 (–2.32 to 0.60) Ref.

CCBT + MCBT 24 –1.96 (–3.22 to –0.70) –1.10 (–3.11 to 0.90) 0.275

CCBT + MCI 25 –1.26 (–2.48 to –0.04) –0.40 (–2.37 to 1.57) 0.684

SDQ-t conduct CCBT 18 0.35 (–0.21 to 0.91) Ref.

subscale
CCBT + MCBT 22 –0.17 (–0.68 to 0.35) –0.52 (–1.30 to 0.27) 0.190

CCBT + MCI 23 –0.11 (–0.62 to 0.39) –0.46 (–1.24 to 0.31) 0.236

Ref., reference category.
a Adjusted for child age, child gender, type of child anxiety disorder (GAD, social phobia, SAD, other), baseline severity
(ADIS-C/P CSR) of the child’s primary anxiety disorder, baseline severity (ADIS-IV mother self-report) of the mother’s
primary anxiety disorder and baseline questionnaire score.

38
NIHR Journals Library www.journalslibrary.nihr.ac.uk
 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

Post-treatment follow-up

Child outcomes at 6-month follow-up

Presence of child’s Anxiety Disorder Interview Schedule primary diagnosis at

6-month follow-up
Table 38 shows the proportion of missing data within each treatment arm for the assessment of the child’s
primary diagnosis at 6 months post treatment. The CCBT arm has the highest proportion of missing
data (31%).

Table 39 shows the proportion of children who recovered from their primary ADIS-C/P anxiety diagnosis by
6 months. The CCBT + MCI arm had the highest proportion of recovered children (75%). The CCBT arm
had the lowest proportion of recovered children (59%).

Table 40 shows the results of the adjusted linear regression of the child’s primary diagnosis. The results
show no statistically significant difference between CCBT + MCBT or CCBT + MCI treatment arms in
comparison with CCBT.

TABLE 38 Presence of pre-treatment ADIS-C/P primary diagnosis at 6 months post treatment (including missing data)

Treatment allocation Missing, n (%) No diagnosis, n (%) Diagnosis, n (%) Total, n (%)
CCBT 22 (30.99) 29 (40.85) 20 (28.17) 71

CCBT + MCBT 16 (23.19) 34 (49.28) 19 (27.54) 69

CCBT + MCI 20 (28.17) 38 (53.52) 13 (18.31) 71

Total 58 101 52 211

TABLE 39 Presence of pre-treatment ADIS-C/P primary diagnosis at 6 months

Treatment allocation No diagnosis, n (%) Diagnosis, n (%) Total, n (%)

CCBT 29 (59.18) 20 (40.82) 49

CCBT + MCBT 34 (64.15) 19 (35.85) 53

CCBT + MCI 38 (74.51) 13 (25.49) 51

Total 101 52 153

TABLE 40 Analysis of pre-treatment ADIS-C/P primary anxiety diagnosis at 6 months

Parameter Adjusted RRa 95% CI p-valueb

Treatment CCBT Ref.

CCBT + MCBT 1.09 0.81 to 1.46 0.566

CCBT + MCI 1.26 0.97 to 1.64 0.077

Ref., reference category.
a Adjusted for child age, child gender, type of child anxiety disorder (GAD, social phobia, SAD, other), baseline severity
(ADIS-C/P CSR) of the child’s primary anxiety disorder and baseline severity (ADIS-IV mother self-report) of the mother’s
primary anxiety disorder.
b Analysis conducted using the modified Poisson regression framework with robust error variance.

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
39
addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
Park, Southampton SO16 7NS, UK.
 TRIAL RESULTS

As in all of the analyses reporting RRs in this report, a value > 1 implies a better outcome for the index
treatment arm compared with the control (CCBT) arm, if the value is < 1, the outcome is better for the
CCBT arm.

Child’s Clinical Global Impression – Improvement at 6 months

The proportion of missing data for child’s CGI-I assessment at 6 months was lower in the CCBT + MCBT
arm (23%) and similar in the CCBT (31%) and CCBT + MCI arms (28%) (Table 41).

The proportion of children who were ‘much/very much improved’ at 6 months is shown in Table 42. The
CCBT + MCI arm had the highest proportion (88%). CCBT and CCBT + MCBT were similar (80% and
77%, respectively).

The linear regression results in Table 43 show that there are no statistically significant differences between
treatment arms.

TABLE 41 Clinical Global Impression: child – Improvement at 6 months (including missing data)

Much/very much Not much/very much

Treatment allocation Missing, n (%) improved, n (%) improved, n (%) Total, n (%)

CCBT 22 (30.99) 39 (54.93) 10 (14.08) 71

CCBT + MCBT 16 (23.19) 41 (59.42) 12 (17.39) 69

CCBT + MCI 20 (28.17) 45 (63.38) 6 (8.45) 71

Total 58 125 28 211

TABLE 42 Clinical Global Impression: child – Improvement at 6 months

Treatment Much/very much improved, Not much/very much improved,

allocation n (%) n (%) Total, n (%)

CCBT 39 (79.59) 10 (20.41) 49

CCBT + MCBT 41 (77.36) 12 (22.64) 53

CCBT + MCI 45 (88.24) 6 (11.76) 51

Total 125 28 153

TABLE 43 Analysis of CGI-I at 6 months

Parameter Adjusted RRa 95% CI p-valueb

Treatment CCBT Ref.

CCBT + MCBT 0.97 0.79 to 1.19 0.771

CCBT + MCI 1.16 0.94 to 1.33 0.216

Ref., reference category.
a Adjusted for child age, child gender, type of child anxiety disorder (GAD, social phobia, SAD, other), baseline severity
(ADIS-C/P CSR) of the child’s primary anxiety disorder and baseline severity (ADIS-IV mother self-report) of the mother’s
primary anxiety disorder.
b Analysis conducted using the modified Poisson regression framework with robust error variance.

40
NIHR Journals Library www.journalslibrary.nihr.ac.uk
 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

Presence of any Anxiety Disorder Interview Schedule anxiety diagnosis in

children at 6 months
As shown in Table 44, the proportion of missing data for any ADIS-C/P anxiety diagnosis was similar in
CCBT (31%) and CCBT + MCI (28%), but lower in MCBT (23%) children.

Table 45 shows the proportion of children recovering from all anxiety diagnoses by 6 months; and this is
the same in each group (47%).

The results of the linear regression of recovery from all ADIS-C/P anxiety diagnoses by 6 months are shown
in Table 46; there are no statistically significant differences between treatment groups.

TABLE 44 Presence of any ADIS-C/P anxiety diagnosis at 6 months (including missing data)

Treatment allocation Missing, n (%) No diagnosis, n (%) Diagnosis, n (%) Total, n (%)

CCBT 22 (30.99) 23 (32.39) 26 (36.62) 71

MCBT 16 (23.19) 25 (36.23) 28 (40.58) 69

CCBT + MCI 20 (28.17) 24 (33.80) 27 (38.03) 71

Total 58 72 81 211

TABLE 45 Presence of any ADIS-C/P anxiety diagnosis at 6 months

Treatment allocation No diagnosis, n (%) Diagnosis, n (%) Total, n (%)

CCBT 23 (46.94) 26 (53.06) 49

CCBT + MCBT 25 (47.17) 28 (52.83) 53

CCBT + MCI 24 (47.06) 27 (52.94) 51

Total 72 81 153

TABLE 46 Analysis of recovery from any ADIS-C/P anxiety diagnosis at 6 months

Parameter Adjusted RRa 95% CI p-valueb

Treatment CCBT Ref.

CCBT + MCBT 1.04 0.70 to 1.53 0.860

CCBT + MCI 1.04 0.71 to 1.55 0.814

Ref., reference category.
a Adjusted for child age, child gender, type of child anxiety disorder (GAD, social phobia, SAD, other), baseline severity
(ADIS-C/P CSR) of the child’s primary anxiety disorder and baseline severity (ADIS-IV mother self-report) of the mother’s
primary anxiety disorder.
b Analysis conducted using the modified Poisson regression framework with robust error variance.

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
41
addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
Park, Southampton SO16 7NS, UK.
 TRIAL RESULTS

Severity of child’s primary Anxiety Disorder Interview Schedule diagnosis at

6 months
Figure 6 and Table 47 show the distribution of the change scores from baseline to 6 months for the
severity rating of the child’s primary diagnosis. As shown in Table 48, the proportion of children with a
reduction of 2 or more points is 74% in the CCBT arm, 70% in the CCBT + MCBT arm and 92% in the
CCBT + MCI arm. When comparing the CCBT + MCBT arm with CCBT there is no significant difference.
However, there is a significant difference between CCBT + MCI and CCBT (p = 0.013).

2
Change in ADIS primary diagnosis severity by 6 months

–2

–4

–6

–8

CCBT CCBT + MCBT CCBT + MCI

FIGURE 6 Box plot of change in severity of child’s pre-treatment ADIS-C/P primary anxiety diagnosis at 6 months.

TABLE 47 Change in severity of child’s pre-treatment ADIS-C/P primary anxiety diagnosis at 6 months, frequency (%)

Treatment
allocation –7 –6 –5 –4 –3 –2 –1 0 1 Total

CCBT 0 (0.0) 12 (24.5) 10 (20.4) 3 (6.1) 3 (6.1) 8 (16.3) 4 (8.2) 6 (12.2) 3 (6.1) 49
CCBT + MCBT 2 (3.8) 16 (30.2) 10 (18.9) 1 (1.9) 2 (3.8) 6 (11.3) 11 (20.8) 5 (9.4) 0 (0.0) 53

CCBT + MCI 2 (3.9) 18 (35.3) 9 (17.7) 5 (9.8) 2 (3.9) 11 (21.6) 4 (7.8) 0 (0.0) 0 (0.0) 51

Total 4 46 29 9 7 25 19 11 3 153

TABLE 48 Proportion of children with at least a 2-point reduction in severity of their pre-treatment ADIS-C/P
primary anxiety diagnosis at 6 months

Treatment n n (%) with a 2 or more point reduction p-valuea

CCBT 49 36 (73.5)

CCBT + MCBT 53 37 (69.8) 0.682

CCBT + MCI 51 47 (92.2) 0.013
a Chi-squared test, comparison with control group.

42
NIHR Journals Library www.journalslibrary.nihr.ac.uk
 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

Analysis of questionnaire data at 6 month follow-up assessments

Analyses of questionnaire results were conducted on the change scores from baseline to the relevant time
point. The change scores were more normally distributed. The change scores were modelled using linear
regression, adjusted for baseline scores and minimisation factors.

In this section, only patients who are included in the analysis are included in the summary tables.

Adjusted analysis of change in child-reported questionnaire scores at

6 months (intention-to-treat analysis)
Table 49 shows the results for the analysis of the child-reported questionnaire scores, and the change in
scores from baseline to 6 months. For all four of the questionnaires there were no significant differences
between CCBT + MCBT and CCBT or between CCBT + MCI and CCBT. The adjusted mean scores for each
treatment group and every questionnaire are negative, which shows that all groups improved. A summary
of the descriptive statistics is given in Appendix 5, Table 136.

Adjusted analysis of change in mother-reported questionnaire scores at

6 months (intention-to-treat analysis)
Table 50 shows results of linear regression looking at mother-reported questionnaires about child
symptoms/impact. For the SDQ-p conduct subscale a significant difference was seen between the
CCBT + MCI and the CCBT arms (p = 0.022), with the CCBT + MCI arm seeing a bigger reduction in
score on average. A summary of the descriptive statistics is given in Appendix 5, Table 137.

Adjusted analysis of change in teacher-reported questionnaire scores at

6 months (intention-to-treat analysis)
The number of respondents was low. As shown in Table 51, no significant differences were seen.
A summary of descriptive statistics are given in Appendix 5, Table 138.

TABLE 49 Adjusted analysis of change in child-reported questionnaire scores at 6 months

Adjusteda mean change Adjusteda mean difference

Variable name Treatment n (95% CI) (95% CI) p-value

CAIS-c total score CCBT 38 –12.45 (–15.06 to –9.84) Ref. –

CCBT + MCBT 43 –11.02 (–13.50 to –8.54) 1.43 (–2.21 to 5.07) 0.4374

41 –10.75 (–13.29 to –8.21) 1.70 (–1.97 to 5.37) 0.3614

SCAS-c total score CCBT 41 –17.85 (–22.73 to –12.98) Ref. –

CCBT + MCBT 43 –16.59 (–21.35 to –11.83) 1.26 (–5.56 to 8.08) 0.7146

CCBT + MCI 41 –17.60 (–22.52 to –12.67) 0.26 (–6.77 to 7.28) 0.9427

SDQ-c conduct CCBT 42 –0.88 (–1.35 to –0.42) Ref. –

subscale
CCBT + MCBT 44 –0.91 (–1.37 to –0.46) –0.03 (–0.68 to 0.62) 0.9245
CCBT + MCI 42 –0.81 (–1.28 to –0.34) 0.07 (–0.60 to 0.74) 0.8317

SMFQ-c total score CCBT 40 –3.81 (–5.33 to –2.29) Ref. –

CCBT + MCBT 44 –3.52 (–4.97 to –2.06) 0.30 (–1.82 to 2.42) 0.7828

CCBT + MCI 39 –3.97 (–5.52 to –2.41) –0.16 (–2.36 to 2.04) 0.8872

Ref., reference category.
a Adjusted for child age, child gender, type of child anxiety disorder (GAD, social phobia, SAD, other), baseline severity
(ADIS-C/P CSR) of the child’s primary anxiety disorder, baseline severity (ADIS-IV mother self-report) of the mother’s
primary anxiety disorder and baseline questionnaire score.

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
43
addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
Park, Southampton SO16 7NS, UK.
 TRIAL RESULTS

TABLE 50 Adjusted analysis of change in mother-reported child symptoms questionnaire scores at 6 months

Adjusteda mean change Adjusteda mean difference

Variable name Treatment n (95% CI) (95% CI) p-value

CAIS-p total score CCBT 35 –9.25 (–12.12 to –6.37) Ref. –

CCBT + MCBT 37 –12.13 (–14.95 to –9.31) –2.88 (–6.92 to 1.16) 0.1599

CCBT + MCI 34 –9.69 (–12.68 to –6.70) –0.44 (–4.61 to 3.73) 0.8348

SCAS-p total score CCBT 36 –17.44 (–21.03 to –13.84) Ref. –

CCBT + MCBT 41 –16.62 (–20.00 to –13.25) 0.82 (–4.11 to 5.74) 0.7432

CCBT + MCI 38 –19.17 (–22.72 to –15.61) –1.73 (–6.86 to 3.40) 0.5050

SDQ-p conduct CCBT 39 –0.47 (–0.86 to –0.09) Ref. –

subscale
CCBT + MCBT 42 –0.99 (–1.36 to –0.62) –0.51 (–1.05 to 0.02) 0.0600

CCBT + MCI 41 –1.11 (–1.49 to –0.73) –0.64 (–1.19 to -0.09) 0.0224

SMFQ-p total score CCBT 36 –4.25 (–5.82 to –2.67) Ref. –

CCBT + MCBT 38 –5.86 (–7.40 to –4.32) –1.61 (–3.83 to 0.61) 0.1542

CCBT + MCI 36 –4.90 (–6.49 to –3.30) –0.65 (–2.91 to 1.61) 0.5701

Ref., reference category.
a Adjusted for child age, child gender, type of child anxiety disorder (GAD, social phobia, SAD, other), baseline severity
(ADIS-C/P CSR) of the child’s primary anxiety disorder, baseline severity (ADIS-IV mother self-report) of the mother’s
primary anxiety disorder and baseline questionnaire score.

TABLE 51 Adjusted analysis of change in teacher-reported questionnaire scores at 6 months

Adjusteda mean change Adjusteda mean difference

Variable name Treatment n (95% CI) (95% CI) p-value

CAS-t total score CCBT 11 –1.43 (–3.85 to 0.99) Ref. –

CCBT + MCBT 17 –2.92 (–4.91 to –0.94) –1.50 (–4.65 to 1.66) 0.3432

CCBT + MCI 23 –1.40 (–3.02 to 0.23) 0.03 (–2.92 to 2.98) 0.9845

SCAS-t total score CCBT 4 –1.88 (–15.75 to 12.00) Ref. –

CCBT + MCBT 9 –15.07 (–22.85 to –7.29) –13.19 (–30.33 to 3.94) 0.1227

CCBT + MCI 15 –10.26 (–15.89 to –4.64) –8.39 (–24.79 to 8.01) 0.2955

SDQ-t conduct CCBT 12 0.57 (–0.36 to 1.50) Ref. –

subscale
CCBT + MCBT 18 –0.21 (–0.98 to 0.57) –0.78 (–1.98 to 0.42) 0.1961
CCBT + MCI 22 0.31 (–0.37 to 1.00) –0.26 (–1.42 to 0.90) 0.6540
Ref., reference category.
a Adjusted for child age, child gender, type of child anxiety disorder (GAD, social phobia, SAD, other), baseline severity
(ADIS-C/P CSR) of the child’s primary anxiety disorder, baseline severity (ADIS-IV mother self-report) of the mother’s
primary anxiety disorder and baseline questionnaire score.

44
NIHR Journals Library www.journalslibrary.nihr.ac.uk
 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

Child outcomes at 12-month follow-up

Presence of child’s Anxiety Disorder Interview Schedule primary diagnosis at

12 months
Table 52 shows that the proportion of missing data for the assessment of the child’s primary diagnosis at
12 months is very similar in the CCBT (39%) and CCBT + MCI (35%) arms, but lower in the CCBT + MCBT
arm (28%).

Table 53 shows that recovery from primary diagnosis is very similar in the CCBT (72%) and CCBT + MCI
arms (74%), whereas in the CCBT + MCBT group it is lower (60%).

The results of the linear regression are shown in Table 54. The results show no statistically significant
difference between the CCBT + MCBT or CCBT + MCI treatment arms in comparison with CCBT.

TABLE 52 Presence of pre-treatment ADIS-C/P primary diagnosis at 12 months (including missing data)

Treatment allocation Missing, n (%) No diagnosis, n (%) Diagnosis, n (%) Total, n (%)

CCBT 28 (39.44) 31 (43.66) 12 (16.90) 71

CCBT + MCBT 19 (27.54) 30 (43.48) 20 (28.99) 69

CCBT + MCI 25 (35.21) 34 (47.89) 12 (16.90) 71

Total 72 95 44 211

TABLE 53 Presence of pre-treatment ADIS-C/P primary diagnosis at 12 months

Treatment allocation No diagnosis, n (%) Diagnosis, n (%) Total, n (%)

CCBT 31 (72.09) 12 (27.91) 43

CCBT + MCBT 30 (60.00) 20 (40.00) 50

CCBT + MCI 34 (73.91) 12 (26.09) 46

Total 95 44 139

TABLE 54 Analysis of pre-treatment ADIS-C/P primary anxiety diagnosis at 12 months

Parameter Adjusted RRa 95% CI p-valueb

Treatment CCBT Ref.

CCBT + MCBT 0.85 0.65 to 1.12 0.257

CCBT + MCI 1.04 0.82 to 1.30 0.766

Ref., reference category.
a Adjusted for child age, child gender, type of child anxiety disorder (GAD, social phobia, SAD, other), baseline severity
(ADIS-C/P CSR) of the child’s primary anxiety disorder and baseline severity (ADIS-IV mother self-report) of the mother’s
primary anxiety disorder.
b Analysis conducted using the modified Poisson regression framework with robust error variance.

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
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addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
Park, Southampton SO16 7NS, UK.
 TRIAL RESULTS

Child’s Clinical Global Impression – Improvement at 12 months

The proportion of 12-month CGI-I assessments that were missing is shown in Table 55. The CCBT arm
had 39% missing, CCBT + MCI had 35% missing and CCBT + MCBT had 28% missing.

As shown in Table 56, the proportion of children who were ‘much/very much improved’ was similar
between treatment groups; between 77% and 80%.

The results of the linear regression of CGI-I at 12 months are shown in Table 57; there are no statistically
significant differences between treatment groups.

TABLE 55 Clinical Global Impression: child – Improvement at 12 months (including missing data)

Much/very much Not much/very much

Treatment allocation Missing, n (%) improved, n (%) improved, n (%) Total, n (%)

CCBT 28 (39.44) 33 (46.48) 10 (14.08) 71

CCBT + MCBT 19 (27.54) 39 (56.52) 11 (15.94) 69

CCBT + MCI 25 (35.21) 37 (52.11) 9 (12.68) 71

Total 72 109 30 211

TABLE 56 Clinical Global Impression: child – Improvement at 12 months

Much/very much Not much/very much

Treatment allocation improved, n (%) improved, n (%) Total, n (%)

CCBT 33 (76.74) 10 (23.26) 43

CCBT + MCBT 39 (78.00) 11 (22.00) 50

CCBT + MCI 37 (80.43) 9 (19.57) 46

Total 109 30 139

TABLE 57 Analysis of CGI-I at 12 months

Parameter Adjusted RRa 95% CI p-valueb

Treatment CCBT Ref.

CCBT + MCBT 1.02 0.82 to 1.27 0.834

CCBT + MCI 1.05 0.85 to 1.30 0.628

Ref., reference category.
a Adjusted for child age, child gender, type of child anxiety disorder (GAD, social phobia, SAD, other), baseline severity
(ADIS-C/P CSR) of the child’s primary anxiety disorder and baseline severity (ADIS-IV mother self-report) of the mother’s
primary anxiety disorder.
b Analysis conducted using the modified Poisson regression framework with robust error variance.

46
NIHR Journals Library www.journalslibrary.nihr.ac.uk
 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

Presence of any Anxiety Disorder Interview Schedule anxiety diagnosis in

children at 12 months
As shown in Table 58, the proportion of missing data for all anxiety diagnoses at 12 months was lowest in
the CCBT + MCBT arm (28%). In the CCBT + MCI arm it is 35% and in the CCBT arm 39%.

The proportion of recovered children was similar in the CCBT arm (53%) and the CCBT + MCI arm (52%).
In the CCBT + MCBT arm the proportion was slightly lower at 46% (Table 59).

The results of the linear regression of recovery from all ADIS-C/P anxiety diagnoses by 12 months are
shown in Table 60. There are no statistically significant differences between treatment groups.

TABLE 58 Presence of any ADIS-C/P anxiety diagnosis at 12 months (including missing data)

Treatment allocation Missing, n (%) No diagnosis, n (%) Diagnosis, n (%) Total, n (%)

CCBT 28 (39.44) 23 (32.39) 20 (28.17) 71

CCBT + MCBT 19 (27.54) 23 (33.33) 27 (39.13) 69

CCBT + MCI 25 (35.21) 24 (33.80) 22 (30.99) 71

Total 72 70 69 211

TABLE 59 Presence of any ADIS-C/P anxiety diagnosis at 12 months

Treatment allocation No diagnosis, n (%) Diagnosis, n (%) Total, n (%)

CCBT 23 (53.49) 20 (46.51) 43

CCBT + MCBT 23 (46.00) 27 (54.00) 50

CCBT + MCI 24 (52.17) 22 (47.83) 46

Total 70 69 139

TABLE 60 Analysis of recovery from any ADIS-C/P anxiety diagnosis at 12 months

Parameter Adjusted RRa 95% CI p-valueb

Treatment CCBT Ref.

CCBT + MCBT 0.89 0.61 to 1.31 0.569

CCBT + MCI 1.01 0.70 to 1.45 0.972

Ref., reference category.
a Adjusted for child age, child gender, type of child anxiety disorder (GAD, social phobia, SAD, other), baseline severity
(ADIS-C/P CSR) of the child’s primary anxiety disorder and baseline severity (ADIS-IV mother self-report) of the mother’s
primary anxiety disorder.
b Analysis conducted using the modified Poisson regression framework with robust error variance.

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
47
addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
Park, Southampton SO16 7NS, UK.
 TRIAL RESULTS

Severity of child’s pre-treatment Anxiety Disorder Interview Schedule primary

diagnosis at 12 months
By 12 months 77% of the control group, 74% of the CCBT + MCBT group and 87% of the CCBT + MCI
group children had seen an improvement of at least 2 points (Figure 7 and Tables 61 and 62).

There were no significant differences between the CCBT + MCBT and CCBT arms or between the
CCBT + MCI and CCBT arms (p = 0.760 and p = 0.210, respectively).

2
Change in ADIS primary diagnosis severity by 12 months

–2

–4

–6

–8

CCBT CCBT + MCBT CCBT + MCI

FIGURE 7 Box plot of change in severity of child’s primary ADIS-C/P anxiety diagnosis at 12 months.

TABLE 61 Change in severity of child’s pre-treatment ADIS-C/P primary anxiety diagnosis at 12 months, frequency (%)

Treatment
allocation –7 –6 –5 –4 –3 –2 –1 0 1 Total

CCBT 3 (6.98) 10 (23.26) 9 (20.93) 5 (11.63) 2 (4.65) 4 (9.30) 7 (16.28) 1 (2.33) 2 (4.65) 43
CCBT + MCBT 3 (6.00) 10 (20.00) 12 (24.00) 1 (2.00) 3 (6.00) 8 (16.00) 6 (12.00) 7 (14.00) 0 (0.00) 50

CCBT + MCI 1 (2.17) 18 (39.1) 8 (17.39) 4 (8.70) 3 (6.52) 6 (13.04) 6 (13.04) 0 (0.00) 0 (0.00) 46

Total 7 38 29 10 8 18 19 8 2 139

TABLE 62 Proportion of children with at least a 2-point reduction in severity of their pre-treatment ADIS-C/P
primary anxiety diagnosis at 12 months

Treatment n n (%) with 2 or more point reduction p-valuea

CCBT 43 33 (76.7)

CCBT + MCBT 50 37 (74.0) 0.760

CCBT + MCI 46 40 (87.0) 0.210
a Chi-squared test, comparison with control group.

48
NIHR Journals Library www.journalslibrary.nihr.ac.uk
 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

Analysis of questionnaire data at 12-month follow-up assessments

Analyses of questionnaire results were conducted on the change scores from baseline to the relevant time
point owing to the skewed distribution of the raw scores at each time point. The change scores were more
normally distributed. The change scores were modelled using linear regression, adjusted for baseline scores
and minimisation factors.

In this section, only patients who are included in the analysis are included in the summary tables.

Adjusted analysis of change in child-reported questionnaire scores at

12 months (intention-to-treat analysis)
As shown in Table 63, no significant differences were seen. A summary of the descriptive statistics is given
in Appendix 5, Table 139.

Adjusted analysis of change in mother-reported questionnaire scores at

12 months (intention-to-treat analysis)
As shown in Table 64, no significant differences were seen. A summary of descriptive statistics is given in
Appendix 5, Table 140.

Adjusted analysis of change in teacher-reported questionnaire scores at

12 months (intention-to-treat analysis)
As shown in Table 65, no significant differences were seen. A summary of descriptive statistics is given in
Appendix 5, Table 141.

Note the small number of observations when looking at these results.

TABLE 63 Adjusted analysis of change in child-reported questionnaire scores at 12 months

Adjusteda mean change Adjusteda mean difference

Variable name Treatment n (95% CI) (95% CI) p-value

CAIS-c total score CCBT 29 –12.83 (–17.14 to –8.51) Ref. –

CCBT + MCBT 33 –9.25 (–13.41 to –5.09) 3.57 (–2.59 to 9.74) 0.2525

CCBT + MCI 37 –11.71 (–15.48 to –7.93) 1.12 (–4.59 to 6.83) 0.6978

SCAS-c total score CCBT 31 –18.11 (–23.18 to –13.03) Ref. –

CCBT + MCBT 34 –18.92 (–23.82 to –14.01) –0.81 (–7.96 to 6.34) 0.8225

CCBT + MCI 37 –17.98 (–22.59 to –13.38) 0.12 (–6.73 to 6.97) 0.9718

SDQ-c conduct CCBT 31 –1.21 (–1.87 to –0.55) Ref. –

subscale
CCBT + MCBT 34 –0.94 (–1.58 to –0.30) 0.27 (–0.65 to 1.18) 0.5622
CCBT + MCI 38 –1.00 (–1.59 to –0.40) 0.21 (–0.68 to 1.10) 0.6373

SMFQ-c total score CCBT 28 –4.08 (–5.95 to –2.21) Ref. –

CCBT + MCBT 35 –4.20 (–5.91 to –2.49) –0.12 (–2.71 to 2.48) 0.9284

CCBT + MCI 37 –2.09 (–3.72 to –0.47) 1.99 (–0.48 to 4.46) 0.1132

Ref., reference category.
a Adjusted for child age, child gender, type of child anxiety disorder (GAD, social phobia, SAD, other), baseline severity
(ADIS-C/P CSR) of the child’s primary anxiety disorder, baseline severity (ADIS-IV mother self-report) of the mother’s
primary anxiety disorder and baseline questionnaire score.

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
49
addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
Park, Southampton SO16 7NS, UK.
 TRIAL RESULTS

TABLE 64 Adjusted analysis of change in mother-reported questionnaire scores at 12 months

Adjusteda mean change Adjusteda mean difference

Variable name Treatment n (95% CI) (95% CI) p-value

CAIS-p total score CCBT 28 –9.50 (–12.44 to –6.56) Ref. –

CCBT + MCBT 27 –12.11 (–15.19 to –9.04) –2.61 (–6.88 to 1.66) 0.2270

CCBT + MCI 31 –12.15 (–14.99 to –9.32) –2.65 (–6.72 to 1.42) 0.1985

SCAS-p total score CCBT 30 –22.37 (–26.62 to –18.12) Ref. –

CCBT + MCBT 31 –16.36 (–20.58 to –12.15) 6.01 (–0.01 to 12.02) 0.0502

CCBT + MCI 33 –20.74 (–24.78 to –16.71) 1.62 (–4.27 to 7.51) 0.5850

SDQ-p conduct CCBT 32 –1.04 (–1.56 to –0.53) Ref. –

subscale
CCBT + MCBT 32 –0.89 (–1.40 to –0.38) 0.16 (–0.57 to 0.89) 0.6685

CCBT + MCI 38 –0.85 (–1.31 to –0.38) 0.20 (–0.50 to 0.89) 0.5755

SMFQ-p total score CCBT 30 –5.14 (–6.81 to –3.48) Ref. –

CCBT + MCBT 29 –4.54 (–6.25 to –2.82) 0.61 (–1.82 to 3.04) 0.6194

CCBT + MCI 33 –5.97 (–7.55 to –4.39) –0.83 (–3.11 to 1.46) 0.4739

Ref., reference category.
a Adjusted for child age, child gender, type of child anxiety disorder (GAD, social phobia, SAD, other), baseline severity
(ADIS-C/P CSR) of the child’s primary anxiety disorder, baseline severity (ADIS-IV mother self-report) of the mother’s
primary anxiety disorder and baseline questionnaire score.

TABLE 65 Adjusted analysis of change in teacher-reported questionnaire scores at 12 months

Adjusteda mean change Adjusteda mean difference

Variable name Treatment n (95% CI) (95% CI) p-value

CAS-t total score CCBT 9 –2.56 (–4.76 to –0.37) Ref. –

CCBT + MCBT 10 –0.04 (–2.23 to 2.14) 2.52 (–0.62 to 5.66) 0.1099

CCBT + MCI 12 –0.40 (–2.29 to 1.48) 2.16 (–0.77 to 5.09) 0.1391

SCAS-t total score CCBT 4 –7.90 (–17.17 to 1.37) Ref. –

CCBT + MCBT 4 –0.04 (–18.30 to 18.22) 7.86 (–12.83 to 28.55) 0.2437

CCBT + MCI 5 –11.90 (–23.14 to –0.66) –4.00 (–18.25 to 10.25) 0.3510

SDQ-t conduct CCBT 9 –0.09 (–1.21 to 1.03) Ref. –

subscale
CCBT + MCBT 11 –0.27 (–1.30 to 0.75) –0.18 (–1.71 to 1.34) 0.8051
CCBT + MCI 12 0.41 (–0.54 to 1.36) 0.50 (–0.99 to 2.00) 0.4903
Ref., reference category.
a Adjusted for child age, child gender, type of child anxiety disorder (GAD, social phobia, SAD, other), baseline severity
(ADIS-C/P CSR) of the child’s primary anxiety disorder, baseline severity (ADIS-IV mother self-report) of the mother’s
primary anxiety disorder and baseline questionnaire score.

50
NIHR Journals Library www.journalslibrary.nihr.ac.uk
 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

Secondary research questions

The extent to which improvement in child anxiety was associated with changes in maternal anxiety and
parenting responses is shown in the following tables of correlations (see Tables 66–75). In each case
Pearson’s correlation coefficient (r), the p-value and the number of observations are shown. For each of
the three child anxiety variables that are used to correlate with other variables, a higher score implies a
worse outcome for the child (as we are looking at the change from baseline).

Associations between change in maternal anxiety and child anxiety

outcomes immediately post treatment (assessment 2)
Table 66 (assessment 1B) and Table 67 (assessment 2) show the correlations between child anxiety
(change in SCAS-c total score, change in CSR of primary diagnosis and CGI-I) and maternal anxiety
(change in CSR of primary diagnosis). In these tables none of the correlations are statistically different
from zero.

Similarly to before, the following table (Table 68) shows the correlations between the change in child
anxiety scores from baseline to assessment 2 (SCAS-c, CSR and CGI-I) and mother anxiety questionnaire
change scores (DASS-21).

TABLE 66 Correlation between child and mother anxiety scores at assessment 1B

Child anxiety change scores (baseline to assessment 1B)

Mother anxiety change scores (baseline to
assessment 1B) SCAS-c CSR of primary diagnosis CGI-I

Change in CSR r 0.03295 0.06790 0.05102

p-value 0.6642 0.3419 0.4753

n 176 198 198

TABLE 67 Correlation between child and mother anxiety scores at assessment 2

Child anxiety change scores (baseline to assessment 2)

Mother anxiety change scores (baseline to
assessment 2) SCAS-c CSR of primary diagnosis CGI-I

Change in CSR r 0.01689 0.03667 0.09354

p-value 0.8447 0.6339 0.2237

n 137 171 171

TABLE 68 Correlations between child and mother anxiety questionnaire change scores at assessment 2

Change in child anxiety (baseline to assessment 2)

Mother anxiety change scores (baseline to
assessment 2) SCAS-c CSR of primary diagnosis CGI-I

DASS-21 anxiety r –0.06825 –0.0036 0.05363

p-value 0.5227 0.9710 0.5943

n 90 101 101

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
51
addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
Park, Southampton SO16 7NS, UK.
 TRIAL RESULTS

Associations between change in maternal parenting responses and child

anxiety outcomes
Table 69 shows the correlations between the same child anxiety ratings and each of the behavioural
change scores at assessment 2. There are significant correlations between change in CSR and change in
overprotection (r = –0.1956; p = 0.0225), CGI-I and change in overprotection (r = –0.3123; p = 0.0002),
CGI-I and change in quality of relationship (r = –0.1097; p = 0.0450).

Similarly, Table 70 shows the correlations between the same child anxiety change scores and each of the
cognition change scores at assessment 2. None of the correlations are statistically different from zero.

TABLE 69 Correlation between change in child anxiety scores and change in mother behavioural change scores
(baseline to assessment 2)

Child anxiety change scores (baseline to assessment 2)

Mother–child behavioural change scores
(baseline to assessment 2) SCAS-c CSR of primary diagnosis CGI-I

Positive behaviour r 0.00914 –0.01251 –0.06857

p-value 0.9220 0.8851 0.4294

n 117 136 135

Overprotection r 0.03525 –0.19558 –0.31226

p-value 0.7059 0.0225 0.0002

n 117 136 135

Promotion of avoidance r 0.02498 –0.04638 0.07694

p-value 0.7892 0.5918 0.3751

n 117 136 135

Intrusiveness r 0.14039 –0.01128 –0.02442

p-value 0.1311 0.8963 0.7786

n 117 136 135

Anxiety r –0.06341 –0.00024 –0.10791

p-value 0.4970 0.9978 0.2129

n 117 136 135

Quality of relationship r –0.03089 –0.15215 –0.17282

p-value 0.7409 0.0770 0.0450

n 117 136 135

POI r 0.17777 –0.00642 0.07565

p-value 0.0848 0.9479 0.4409

n 95 106 106
POI, Parent Over-Involvement Questionnaire.

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NIHR Journals Library www.journalslibrary.nihr.ac.uk
 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

TABLE 70 Correlation between change in child anxiety scores and change in mother cognition change scores
(baseline to assessment 2)

Child anxiety change scores (baseline to assessment 2)

Mother–child cognition change scores
(baseline to assessment 2) SCAS-c CSR of primary diagnosis CGI-I

Pre-task ‘scared’ r 0.15092 0.00701 0.16665

p-value 0.1122 0.9367 0.0581

n 112 131 130

Pre-task ‘anxious’ r –0.02832 0.01928 0.07960

p-value 0.7669 0.8270 0.3680

n 112 131 130

Pre-task ‘child in control’ r –0.03400 –0.04478 –0.08487

p-value 0.7219 0.6115 0.3370

n 112 131 130

Pre-task ‘mother in control’ r 0.17628 0.04862 0.04707

p-value 0.0630 0.5813 0.5949

n 112 131 130

Associations between change in maternal anxiety and child anxiety

outcomes 6 and 12 months post treatment (assessments 3 and 4)
Tables 71 and 72 show correlations between change in child anxiety scores and change in mother anxiety
questionnaire scores from baseline to the 6- and 12-month post-treatment follow-up assessment.
At the 6-month time point none of the correlations were statistically significant. At 12 months, maternal
general anxiety (DASS-21) was significantly associated with change in the CSR of the child’s primary
diagnosis (p = 0.0195).

TABLE 71 Correlations between change in child anxiety scores and change in mother anxiety questionnaire score
at 6 months (assessment 3)

Child change scores (baseline to 6 months)

Mother change scores (baseline to
6 months) SCAS-c CSR of primary diagnosis CGI-I

DASS-21 anxiety r 0.08825 –0.06079 0.06979

p-value 0.3875 0.5359 0.4772

n 98 106 106

TABLE 72 Correlations between change in child anxiety scores and change in mother anxiety questionnaire score
at 12 months

Child change scores (baseline to 12 months)

Mother change scores (baseline to
12 months) SCAS-c CSR of primary diagnosis CGI-I

DASS-21 anxiety r –0.05089 –0.25755 –0.05375

p-value 0.6624 0.0195 0.6315

n 76 82 82

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
53
addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
Park, Southampton SO16 7NS, UK.
 TRIAL RESULTS

Observations of parental behaviours and cognitions were not made at the 6- and 12-month follow-up
assessments, so associations between change in these variables and longer-term outcomes were assessed
on the basis of maternal behavioural and cognition change scores at assessment 2 and child anxiety
outcomes at 6 and 12 months (Tables 73 and 74). Change in maternal overprotection at assessment 2 was
associated with CGI-I at 6 months (p = 0.044) and change in child anxiety symptoms (SCAS-c) at
12 months (p = 0.004). Change in maternal intrusiveness was significantly associated with child CGI-I
at 12 months (p = 0.009). In relation to maternal cognitions, change in pre-task expectations of how
much the mother would be in control of her child’s response was significantly associated with change in
child anxiety symptoms at 6 months (SCAS-c) (p = 0.022).

Parent-reported overinvolvement was assessed at all assessments so concurrent change in this variable
could be correlated with child outcomes at the 6- and-12 month assessments, as shown in Table 75.
There were no significant correlations.

TABLE 73 Correlation between change in child anxiety scores at 6 and 12 months and change in mother
behavioural change scores (baseline to assessment 2)

Child anxiety change scores (baseline Child anxiety change scores (baseline
to 6 months) to 12 months)

Mother–child behavioural CSR of CSR of

change scores (baseline to primary primary
assessment 2) SCAS-c diagnosis CGI-I SCAS-c diagnosis CGI-I
Positive r 0.14050 –0.02741 0.02782 –0.00056 0.00176 0.03081
behaviour
p-value 0.1489 0.7615 0.7581 0.9958 0.9850 0.7416

n 107 125 125 90 117 117

Overprotection r 0.12875 0.05708 –0.18019 0.30408 0.03819 –0.09012

p-value 0.1863 0.5272 0.0443 0.0036 0.6827 0.3339

n 107 125 125 90 117 117

Promotion r 0.01996 –0.05951 0.03262 –0.02830 0.03669 0.05961

of avoidance
p-value 0.8383 0.5098 0.7180 0.7912 0.6945 0.5232

n 107 125 125 90 117 117

Intrusiveness r 0.03897 0.11560 –0.05094 –0.05594 –0.07602 –0.24017

p-value 0.6902 0.1992 0.5726 0.6005 0.4153 0.0091

n 107 125 125 90 117 117

Expressed anxiety r –0.09444 –0.10867 –0.11103 –0.14463 –0.02053 –0.16905

p-value 0.3333 0.2277 0.2177 0.1738 0.8261 0.0685

n 107 125 125 90 117 117

Quality of r –0.03542 –0.09344 –0.06767 0.00020 –0.10428 –0.11616

relationship
p-value 0.7172 0.3000 0.4534 0.9985 0.2632 0.2123

n 107 125 125 90 117 117

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NIHR Journals Library www.journalslibrary.nihr.ac.uk
 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

TABLE 74 Correlation between change in child anxiety scores at 6 and 12 months and change in mother cognition
change scores (baseline to assessment 2)

Child anxiety change scores (baseline to Child anxiety change scores (baseline
6 months) to 12 months)

Mother–child cognition CSR of CSR of

change scores (baseline to primary primary
assessment 2) SCAS-c diagnosis CGI-I SCAS-c diagnosis CGI-I

Pre-task ‘scared’ r 0.05618 0.13760 0.06005 0.14249 –0.05847 –0.02565

p-value 0.5711 0.1323 0.5129 0.1906 0.5384 0.7874

n 104 121 121 86 113 113

Pre-task r 0.00674 0.07552 –0.00865 –0.04708 –0.02433 –0.06011

‘anxious’
p-value 0.9458 0.4103 0.9249 0.6669 0.7981 0.5271

n 104 121 121 86 113 113

Pre-task ‘child r 0.06490 –0.16300 –0.05574 0.12284 0.00607 –0.01974

in control’
p-value 0.5127 0.0740 0.5437 0.2598 0.9492 0.8356
n 104 121 121 86 113 113

Pre-task r 0.22508 0.06698 0.03040 0.20293 –0.05837 0.01778

‘mother control’
p-value 0.0216 0.4654 0.7406 0.0609 0.5391 0.8517

n 104 121 121 86 113 113

TABLE 75 Correlation between change in child anxiety scores and change in maternal-reported overprotection at
6 and 12 months

POI change scores SCAS-c CSR of primary diagnosis CGI-I

Baseline to 6-month follow-up r 0.11522 –0.05258 0.07649

p-value 0.2488 0.5854 0.4270

n 102 110 110

Baseline to 12-month follow-up r 0.09522 –0.06828 0.04747

p-value 0.3860 0.5201 0.6568

n 85 91 90
POI, Parent Over-Involvement Questionnaire.

Adverse events

Adverse events were defined as follows:

Adverse or unexpected events resulting in physical or psychological injury that arise from the
administration of research procedures or the provision of treatment within the trial. This will include
events such as breach of confidentiality, adverse therapeutic interventions, diagnostic error, improper
staff behaviour, falls and injury.

There were no adverse events.

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
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 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

Chapter 4 Economic evaluation: cost–utility

analysis of treatment of childhood anxiety disorder in
the context of maternal anxiety disorder

Introduction

The aim of the economic evaluation was to assess the cost-effectiveness of the CCBT + MCBT and
CCBT + MCI treatment arms compared with the CCBT treatment arm. This design mirrored the study
research questions, and hence was equivalent to conducting two separate economic evaluations, that
is CCBT + MCBT versus CCBT, and CCBT + MCI versus CCBT. An incremental comparison between
CCBT + MCBT and CCBT + MCI was not a research question and the statistical and economic analyses
were not powered for this comparison. The primary economic analyses followed an ITT approach and
adopted a health service provider perspective. The economic analyses aligned with the primary aim
of the trial, namely to evaluate whether or not the CCBT treatment arm could be improved by the
addition of (i) treatment of maternal anxiety disorders (MCBT), or (ii) treatment focused on maternal
responses (MCI). Secondary economic analyses complemented the results of the primary analyses by
measuring additional mother and child resource use of health and personal social services beyond the
main costs of the treatment. Broader impacts on other sectors, including education and employment, were
also measured. Data were collected on time off school for children and time off work and usual activities
for mothers/carers.

Methods

The primary economic analyses for both comparisons consisted of a cost–utility analysis (CUA) conducted
from a health service provider perspective. Secondary economic analyses supplemented the primary results
by identifying, measuring and valuing resource use impacts from a wider social and personal social service
perspective in addition to measuring the impact on the education and employment sectors. Recent
methods guidance on the conduct, reporting and presentation of economic evaluations were adhered.75–77
Costs and outcomes were combined within a CUA framework and presented using incremental
cost-effectiveness ratios (ICERs) with uncertainty represented using the cost-effectiveness plane. The results
were also reported using net monetary benefit (NMB). Prices were reported in 2011/12 as the base year,
adjusted for inflation using Retail Price Index (RPI) 201278 or Hospital and Community Health Service
(HCHS) index 2011/1279 as appropriate. All statistical analyses were performed using Stata version 12.1.
Statistical significance was set at p-values < 0.05.

Identification and measurement of health and social care resource use

Patient-level resource use data, including all associated treatment costs, additional health and personal
social service costs, were identified and measured as an integral part of the trial data collection process.
Resource use data were collected via a ‘bottom up’ approach where detail on the intervention and control
resources used to deliver the CCBT + MCBT, CCBT + MCI and CCBT treatment arms were identified and
measured via the use of a specially designed ‘therapist resource use log’. This log was designed for trial
therapists to complete every time a contact was made. Details for all types of visit (e.g. client face-to-face
visit, phone contact, school visit) were collected by recording all resources used, duration of any contact
with the patient as well as other resources such as travel mileage, rail fares or other expenses incurred
during the contact. See Appendix 3, Health economic logs, for a copy of the therapist resource use log.

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
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 ECONOMIC EVALUATION

A patient-held ‘resource use’ diary was developed to capture any additional health and social care
resources used by the mother and child beyond the therapy sessions (see Appendix 3, Health economics
diary/patient-held resource use diary). The aim of the diary was to aid recall, that is for the use of mothers
as a means of recording relevant resource use information for them and their children during the time
between assessments (baseline to assessment 1B for mid-intervention; assessment 1B to assessment 2
for post intervention; assessment 2 to 6 months for the 6-month follow-up; 6 months to 12 months for
the 12-month follow-up), so that they might be able to complete the mid- and post-intervention
questionnaires more efficiently. The resource use diaries comprised three sections. The first section
included questions on use of primary and secondary care health services (except the main anxiety
intervention), of other social services (e.g. social worker contacts) and of services provided by government
bodies other than the NHS (e.g. education department). The second section aimed to collect information
on drug treatment by asking mothers whether or not they and/or their children made use of medications
and if the latter were GP prescribed or purchased ‘over-the-counter’. Finally, in a bid to capture broader
societal impacts on employment and education, the third section asked mothers to report how much time
they had to take off work and/or usual activities owing to ill health and how many days off school their
children had taken owing to ill health.

Valuation of health and social care resource use

For each trial participant (mother and child), all components of treatment costs stratified by category of
resource use were computed by multiplying units of resource use by their unit costs. These were then
summed over all resource use categories to obtain a total annual cost for each participant. Unit cost
sources included NHS reference costs and unit costs of community care.79–86 Unit costs can be found in
Appendix 3, Table 89. Primary economic analyses focused only on the NHS cost of the alternative anxiety
treatments; preliminary secondary analyses included also wider societal and further health and social care
costs and will be developed further to include cost of medications and time off work. Prescription cost
analysis87 and published literature will be used to identify unit costs of prescribed and ‘over-the-counter’
drugs, respectively, whereas time off work will be valued using the human capital approach, using the
median gross weekly earnings by age and sex.88 Values are expressed in 2011/12 UK pounds sterling (£).
Values available only in 2010/11 or earlier prices were adjusted for inflation using RPI 201278 or the HCHS
pay and price inflation index 2011/12.79 As the duration of the study was 12 months, discounting of future
costs and benefits was not required.

Identifying and measuring outcomes: quality-adjusted life-years

In line with National Institute for Health and Care Excellence (NICE) recommendations, outcomes in the
economic analyses were identified and measured using quality-adjusted life-years (QALYs). Data to
estimate QALYs for mothers were collected through the European Quality of Life-5 Dimensions (EQ-5D)
self-completion questionnaire,89 which was administered to mothers at baseline, assessment 1B
(mid-treatment), assessment 2 (post treatment), and at 6- and 12-month follow-ups. For children the
EQ-5D child-friendly version was used.90 The EQ-5D is a generic measure of health-related quality of life,
designed to estimate QALYs and widely used across disease areas. It contains five questions each
concerned with a different area or ‘domain’ of everyday life: mobility; self-care; usual activities such as
work, study, housework and leisure activities; pain/discomfort; and anxiety/depression. The answers to
these questions provide a description or profile of the respondent’s quality of life and a value is then
attached to each profile using the results of a large UK general population survey.91 The tariff was used to
estimate health-related quality of life (EQ-5D scores) for each child and mother at baseline, assessment 1B
(mid-treatment), assessment 2 (post treatment), and at 6- and 12-month follow-ups. These EQ-5D utilities
were then combined with duration spent in each health state to estimate QALY gain over the 12-month
period of the study, assuming linear changes of utility between measurements and linear interpolation to
identify the area under the curve for the 12-month period.92 QALYs were computed using the area under
the curve approach, weighting the 12-month period by utility measured on a scale from 0 to 1.92

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 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

Reporting and presenting results

Within the primary economic analyses the mean volume of health-care resources associated with each arm
were estimated and reported together with their standard errors (CCBT + MCBT, CCBT + MCI and CCBT).
Mean differences were calculated using ordinary least squares (OLS) regression to reflect the trial
comparisons: first the incremental resources used by the CCBT + MCBT arm versus the CCBT arm, and
second the incremental resources used by the CCBT + MCI arm versus the CCBT arm. Differences in
resource use are reported alongside 95% CIs.

Within the secondary economic analyses, health-care services other than those associated with the
intervention, other personal social services, non-NHS resources and medication use, were investigated both
for the mother and the child in each arm using descriptive statistics on the available data. More specifically,
mean resource use volumes were reported with their SDs for mother and child separately over the following
periods: baseline to assessment 1B (mid-treatment); assessment 1B to assessment 2 (post treatment);
assessment 2 to 6 months follow-up; and from 6 months to 12 months follow-up.

In the primary analyses the total intervention cost per participant (mother and child) was estimated by
multiplying the volume of each item of resource used by the unit cost of that item, then summing each item
cost for each participant. Mean costs were estimated and reported together with their standard errors for
each trial arm. Statistical differences in mean cost estimates across trial arms (CCBT + MCBT vs. CCBT; and
CCBT + MCI vs. CCBT) were evaluated using OLS regression. Robustness checks were conducted using
generalized linear modelling estimates to account for skewedness of cost data. Similar analyses were
conducted in relation to wider health and social care costs in the preliminary secondary analyses. In those
cases, however, total cost per patient was first calculated over each period between measurements,
namely from baseline to assessment 1B (mid-treatment); from assessment 1B to assessment 2 weeks (post
treatment); from assessment 2 to 6 months follow-up; and from 6 months to 12 months follow-up, and then
summed for each patient in order to obtain a total cost over the 12-month period. Cost estimates were
calculated for mother and child separately and then combined into one variable.

In order to inform whether or not either intervention is cost-effective, current methods recommended by
NICE technology assessment guidance have been adopted to report and present the results of the
incremental costs and QALYs for each comparison (CCBT + MCBT vs. CCBT; CCBT + MCI vs. CCBT). The
methods recommended by NICE are to combine incremental costs and outcomes within an ICER and to
report the joint distribution of the bootstrapped ICERs on a cost-effectiveness plane to provide information
on the associated uncertainty around this point estimate. Currently NICE uses a threshold range of
£20,000–30,000 per QALY gained (i.e. any ICER within or below this range would be deemed a cost-effective
use of resources). Mean incremental cost of the intervention and mean child QALYs were combined within
an ICER for CCBT + MCBT versus CCBT and CCBT + MCI versus CCBT, respectively. Uncertainty around
matched costs and QALY dyads were explored using both a parametric (Fieller’s theorem93,94) and
non-parametric (bootstrap method95,96) approach. Within the bootstrap approach, uncertainty was
investigated using 1000 bootstrapped samples to generate multiple cost–effect pairs, and displayed and
analysed using cost-effectiveness acceptability curves (CEACs).97 CEACs show the probability of a treatment
being cost-effective given a wide range of willingness-to-pay threshold values for health gains. In addition, a
linear representation of the CEAC, incorporating values for societal willingness to pay, NMB, was calculated
for CCBT + MCBT and CCBT + MCI versus CCBT, respectively, as:

NMBi (λ) = λE i − C i , (1)

where Ei and Ci are the observed differences in effects (E) and costs (C), respectively, for patient ‘i’ and λ is
the societal willingness to pay for a health gain. Where NMB is positive, this suggests the intervention is a
worthwhile use of resources. The NMB framework can be seen as an alternative way of representing
the ICER.

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
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addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
Park, Southampton SO16 7NS, UK.
 ECONOMIC EVALUATION

In the secondary analyses, days off school for the child and days off work and/or usual activities for the
mother due to ill health were investigated using descriptive statistics. Further analyses will be developed to
explore mean differences statistically and to include a valuation of lost productivity using the human capital
approach with standard valuations to avoid bias.98

Sensitivity analysis
Sensitivity analysis around key variables is performed in a bid to determine the key factors influencing
cost-effectiveness. A key question is uncertainty in the cost-effectiveness analysis related to the impact of
reducing the treatment costs of non-specific interventions. Hence, sensitivity analysis was conducted by
setting the treatment costs related to non-specific interventions to zero. Treatment costs related to
non-specific interventions included NDC and the FH control delivered to balance groups for therapist
contact. Exploring the impact of reducing these costs was intended to reflect what would happen in reality
if the interventions were adopted in current practice. Further sensitivity analysis will be developed by
altering other key assumptions to explore their consequences for the results at the 12-month follow-up.
In particular, an exploration of the incorporation of broader societal impacts on the cost-effectiveness
results will be carried out, as well as further exploration of the results of the cost-effectiveness analysis to
include combined child and maternal QALYs in the full CUA. The latter were not included in the primary
analyses (only the child QALYs) in order to mirror the main trial outcomes.

Handling missing data

The primary economic evaluation adopted an ITT approach and missing data on resource use and health
outcomes were imputed using two different methods. For face-to-face therapist contacts, where missing
data values were highly deterministic (i.e. readily identifiable and standardised given observed practice), a
conditional imputation method was conducted whereby missing data were estimated as an average of
know durations for that client and session type. For the other resource use (mainly supervision time), costs
(i.e. reward costs) and health outcomes (EQ-5D), where missing data were presented in higher
percentages, multiple imputation was performed using a chained equation procedure99 and 20 imputed
data sets were generated using the Stata command ‘mi impute chained’. Prediction equations for each
imputation variable were customised and allowed to differ. Conditional models for imputed variables are
specified in Appendix 3, Health economic supplementary material section 1.

Results

Data completeness
Data were missing because questionnaires were not fully completed at all time points. However, a high
percentage of complete data were obtained from the likely key drivers, the therapist log for the
intervention and control service costs (e.g. 76.8% complete for MCBT contact time). Complete EQ-5D data
from mothers and child-friendly EQ-5D data for children ranged from 47.9% to 91.3% for mother
and from 46.5% to 98.6% for children. Detailed percentages of missing data are presented in Appendix 3,
Tables 90 and 91 to maximise transparency and aid interpretation of results. A complete case analysis was
not possible owing to the high percentage of missing data across resource use and health outcomes.
Restricting the sample to those children who had the EQ-5D measured at each assessment reduced the
sample size to just above one-third of the initial sample (77 vs. 211). These results were underpowered and
are therefore unreliable hence not reported, but they are available from the authors on request.

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 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

Resource use: therapy time

Utilising data obtained from the therapists’ log, Table 76 provides a detailed descriptive breakdown of the
specific components of health-care resources used across each trial’s arm (face-to-face contact with
patients, supervision time, preparation time, travel time and mileage). The principal resource used for the
intervention was the staff time that the therapists spent directly with the patient, preparation time and
travelling time.

Table 77 reports the incremental mean time differences in minutes between CCBT + MCBT and CCBT.
Although the total time difference between the groups is not statistically significant, individual items
including duration of treatment for maternal anxiety, travel time and mileage are all significantly higher in
the CCBT + MCBT arm.

Table 78 reports incremental differences between the CCBT + MCI and CCBT treatment arms. Total
time differences between the arms are not statistically significant; however, there are statistically significant
differences among individual items including time spent providing CCBT, MCBT/NDC, MCI/FH; treatment
and supervision time for MCBT/NDC; and treatment and supervision time for MCI/FH.

TABLE 76 Detailed treatment resource use volumes

CCBT + MCBT (n = 69), CCBT + MCI (n = 71), CCBT (n = 71), mean

Resource use item mean (SD) (minutes) mean (SD) (minutes) (SD) (minutes)

CCBT 423.95 (143.26) 454.31 (147.13) 391.74 (183.95)

MCBT 380.79 (106.30) NA NA

Maternal counselling (NDC) NA 108.77 (20.27) 329.73 (110.05)

a
MCI treatment (MCI; mother only) NA 399.79 (132.24) NA
a
MCI treatment (MCI; mother and child) NA 58.94 (37.56) NA

FH 143.41 (65.11) NA 138.61 (70.85)

Supervision time for CCBT (therapist time) 26.22 (3.42)b 30.43 (3.77)b 26.22 (3.55)b

Supervision time for CCBT (supervisor time) 26.22 (3.42)b 30.43 (3.77)b 26.22 (3.55)b
Supervision time for MCBT/NDC 46.03 (4.59)b 35.50 (5.09)b 52.21 (6.62)b
(therapist time)

Supervision time for MCBT/NDC 46.03 (4.59)b 35.50 (5.09)b 52.21 (6.62)b
(supervisor time)

Supervision time for MCI/FH (therapist time) 8.77 (2.36)b 24.99 (2.55)b 9.09 (2.06)b

Supervision time for MCI/FH (supervisor time) 8.77 (2.36)b 24.99 (2.55)b 9.09 (2.06)b

Travel (duration) 317.13 (437.18) 221.48 (379.50) 191.08 (298.52)

Travel (mileage) 181.31 (260.03) 127.73 (231.39) 105.69 (180.75)

Other 33.04 (48.06) 20.61 (49.35) 30.26 (86.41)

Extra time associated to ‘not attended’ 0.80 (4.67) 3.52 (17.14) 0.42 (3.56)
sessions (e.g. waiting time, phone call, etc.)
Reward (monetary only) £0.97 (2.14) £1.07 (2.34) £0.86 (2.14)

Parking (monetary only) £0.10 (0.84) £0.03 (0.24) £0

NA, not applicable.
a One child/mother belonging to the MCBT treatment arm also received MCI ‘mother only’ (minutes = 420) and ‘child and
mother’ treatment (minutes = 35) (see Chapter 2, Statistical analysis).
b Standard error in parentheses, as variable is multiply imputed or is derived from other multiply imputed variables.

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
61
addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
Park, Southampton SO16 7NS, UK.
 ECONOMIC EVALUATION

TABLE 77 Treatment resource use mean differences: CCBT + MCBT vs. CCBT

Mean differences
CCBT + MCBT CCBT (n = 71), (minutes):
(n = 69), mean (SD) mean (SD) CCBT + MCBT – CCBT
Resource use item (minutes) (minutes) (95% CI) p-value
CCBT 423.95 (143.26) 391.74 (183.95) 32.21 (–22.99 to 87.41) 0.251

MCBT/NDC 380.79 (106.30) 329.73 (110.05) 51.06 (14.89 to 87.24) 0.006

MCI/FH 150.00 (72.94) 138.61 (70.85) 11.39 (–12.63 to 35.43) 0.350

a a
Supervision time for CCBT 26.22 (3.42) 26.22 (3.55) 0.0019596 (–9.10 to 9.10) 1.000
(therapist time)
Supervision time for CCBT 26.22 (3.42)a 26.22 (3.55)a 0.0019596 (–9.10 to 9.10) 1.000
(supervisor time)

Supervision time for MCBT/NDC 46.03 (4.59)a 52.21 (6.62)a –6.18 (–22.77 to 10.42) 0.456
(therapist time)

Supervision time for MCBT/NDC 46.03 (4.59)a 52.21 (6.62)a –6.18 (–22.77 to 10.42) 0.456
(supervisor time)

Supervision time for MCI/FH 8.77 (2.36)a 9.09 (2.06)a –0.32 (–5.88 to 5.24) 0.905
(therapist time)

Supervision time for MCI/FH 8.77 (2.36)a 9.09 (2.06)a –0.32 (–5.88 to 5.24) 0.905
(supervisor time)

Preparation time and record 376.22 (192.47) 404.28 (191.75) –28.06 (–92.27 to 36.15) 0.39
keeping

Travel (duration) 317.13 (437.18) 191.08 (298.52) 126.05 (1.25 to 250.84) 0.048

Travel (mileage) 181.31 (260.03) 105.69 (180.75) 75.63 (0.97 to 150.29) 0.047
Other 33.04 (48.06) 30.26 (86.41) 2.78 (–20.68 to 26.24) 0.815

Extra time associated to ‘not 0.80 (4.67) 0.42 (3.56) 0.37 (–1.01 to 1.76) 0.594
attended’ sessions (e.g. waiting
time, phone call, etc.)

Total therapy resource useb 1843.98 (81.78)a 1661.18 (78.67)a 182.79 (–40.92 to 406.51) 0.108
(minutes)
a Standard error in parentheses, as variable is multiply imputed or is derived from other multiply imputed variables.
b Excluding travel mileage, which is not expressed in minutes.

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 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

TABLE 78 Treatment resource use mean differences: CCBT + MCI vs. CCBT

Mean differences
CCBT (n = 71), (minutes):
CCBT + MCI (n = 71), mean (SD) CCBT + MCI – CCBT
Resource use item mean (SD) (minutes) (minutes) (95% CI) p-value
CCBT 454.31 (147.13) 391.74 (183.95) 62.57 (7.30 to 117.84) 0.027

MCBT/NDC 108.77 (20.27) 329.73 (110.05) –220.97 (–247.22 to –194.71) 0.000

MCI/FH 458.73 (148.85) 138.61 (70.85) 320.12 (281.45 to 358.80) 0.000

a a
Supervision time for CCBT 30.43 (3.77) 26.22 (3.55) 4.21 (–6.52 to 14.94) 0.436
(therapist time)
Supervision time for CCBT 30.43 (3.77)a 26.22 (3.55)a 4.21 (–6.52 to 14.94) 0.436
(supervision time)

Supervision time for MCBT/NDC 35.50 (5.09)a 52.21 (6.62)a –16.72 (–32.21 to –1.22) 0.035
(therapist time)

Supervision time for MCBT/NDC 35.50 (5.09)a 52.21 (6.62)a –16.72 (–32.21 to –1.22) 0.035
(supervision time)

Supervision time for MCI/FH 24.99 (2.55)a 9.09 (2.06)a 15.90 (9.30 to 22.49) 0.000
(therapist time)

Supervision time for MCI/FH 24.99 (2.55)a 9.09 (2.06)a 15.90 (9.30 to 22.49) 0.000
(supervision time)

Preparation time and record 346.93 (157.95) 404.28 (191.75) –57.36 (–115.64 to 0.93) 0.054
keeping

Travel (duration) 221.48 (379.50) 191.08 (298.52) 30.39 (–82.89 to 143.68) 0.597

Travel (mileage) 127.73 (231.39) 105.69 (180.75) 22.05 (–46.85 to 90.94) 0.528
Other 20.61 (49.35) 30.26 (86.41) –9.65 (–32.99 to 13.70) 0.415

Extra time associated to ‘not 3.52 (17.14) 0.42 (3.56) 3.10 (–1.01 to 7.21) 0.138
attended’ sessions (e.g. waiting
time, phone call, etc.)

Total therapy resource useb 1796.18 (75.27)a 1661.18 (78.67)a 134.99 (–79.71 to 349.69) 0.216
(minutes)
a Standard error in parentheses, as variable is multiply imputed or is derived from other multiply imputed variables.
b Excluding travel mileage, which is not expressed in minutes.

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
63
addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
Park, Southampton SO16 7NS, UK.
 ECONOMIC EVALUATION

Cost of therapy
Resource differences in time for CCBT + MCBT versus CCBT are translated into cost differences in Table 79
below and reveal a borderline statistically significant difference in total cost between the groups, with
CCBT + MCBT being £233.55 more expensive than the CCBT arm.

Resource differences in time for CCBT + MCI versus CCBT are translated into cost differences in Table 80
and reveal a borderline statistically significant difference in total cost between the groups, with the
CCBT + MCI arm being £233.16 more expensive that the CCBT arm.

TABLE 79 Treatment cost mean differences: CCBT + MCBT vs. CCBT

CCBT + MCBT CCBT (n = 71), Mean differences:

Costa (n = 69), mean (SD) mean (SD) CCBT + MCBT – CCBT (95% CI) p-value

CCBT £621.65 (210.07) £574.42 (269.72) £47.23 (–£33.72 to £128.17) 0.251

MCBT/NDC £558.37 (155.87) £483.50 (161.38) £74.87 (£21.83 to £127.91) 0.006

MCI/FH £219.96 (106.96) £203.24 (103.88) £16.71 (–£18.52 to £51.95) 0.350

Supervision time for £17.11 (2.23)b £17.11 (2.32)b £0.001 (–£5.94 to £5.94) 1.000
CCBT (therapist time)
Supervision time for £30.93 (4.03)b £30.92 (4.19)b £0.002 (–£10.73 to £10.74) 1.000
CCBT (supervision time)

Supervision time for £30.04 (2.99)b £34.07 (4.32)b –£4.03 (–£14.87 to £6.80) 0.456
MCBT/NDC
(therapist time)

Supervision time for £54.29 (5.41)b £61.59 (7.80)b –£7.29 (–£26.88 to £12.29) 0.456
MCBT/NDC
(supervision time)
Supervision time for £5.72 (1.54)b £5.93 (1.35)b –£0.21 (–£3.84 to £3.42) 0.905
MCI/FH (therapist time)

Supervision time for £10.34 (2.79)b £10.72 (2.43)b –£0.38 (–£6.94 to £6.18) 0.905
MCI/FH (supervision time)
Preparation time and £245.49 (125.58) £263.80 (125.11) –£18.31 (–£60.21 to £23.59) 0.389
record keeping

Travel (duration) £206.93 (285.26) £124.68 (194.78 £82.24 (£0.82 to £163.67) 0.048

Travel (mileage) £97.91 (140.42) £57.07 (97.60) £40.84 (£0.52 to £81.16) 0.047
Other £21.56 (31.36) £19.75 (56.39) £1.81 (–£13.50 to £17.12) 0.815

Extra time associated to £0.52 (3.05) £0.28 (2.32) £0.24 (–£0.66 to £1.15) 0.594
‘not attended’ sessions
(e.g. waiting time,
phone call, etc.)

Rewards £3.95 (0.46)b £4.22 (0.48)b –£0.27 (–£1.72 to £1.18) 0.763

Parking £0.10 (0.84) £0 NA £0.10 (–£0.10 to £0.30) 0.312

b b
Treatment total cost £2124.85 (84.98) £1891.30 (87.14) £233.55 (–£6.81 to £473.92) 0.057
NA, not applicable.
a Time delivering treatments (CCBT, MCBT/NDC, MCI/FH) was cost at the therapist–client contact hourly rate, whereas the
other therapist’s time was cost at the therapist standard hourly rate.
b Standard error in parentheses, as variable is multiply imputed or is derived from other multiply imputed variables.

64
NIHR Journals Library www.journalslibrary.nihr.ac.uk
 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

TABLE 80 Treatment cost mean differences: CCBT + MCI vs. CCBT

CCBT + MCI Mean differences:

(n = 71), CCBT (n = 71), CCBT + MCI – CCBT + MCBT
Costa mean (SD) mean (SD) (95% CI) p-value

CCBT £666.18 (215.74) £574.42 (269.72) £91.75 (£10.71 to £172.80) 0.027

MCBT/NDC £159.49 (29.72) £483.50 (161.38) –£324.01 (–£362.51 to –£285.51) 0.000

MCI/FH £672.65 (218.26) £203.24 (103.88) £469.41 (£412.69 to £526.13) 0.000

Supervision time for CCBT £19.85 (2.46)b £17.11 (2.32)b £2.75 (–£4.25 to £9.75) 0.436
(therapist time)
Supervision time for CCBT £35.89 (4.44)b £30.92 (4.19)b £4.96 (–£7.69 to £17.62) 0.436
(supervision time)

Supervision time for £23.16 (3.32)b £34.07 (4.32)b –£10.91 (–£21.02 to –£0.80) 0.035
MCBT/NDC (therapist time)
Supervision time for £41.87 (6.00)b £61.59 (7.80)b –£19.72 (–£37.99 to–£1.44) 0.035
MCBT/NDC
(supervision time)
Supervision time for MCI/FH £16.31 (1.66)b £5.93 (1.35)b £10.37 (£6.07 to £14.68) 0.000
(therapist time)

Supervision time for MCI/FH £29.48 (3.01)b £10.72 (2.43)b £18.75 (£10.97 to £26.53) 0.000
(supervision time)

Preparation time and £226.37 (103.06) £263.80 (125.11) –£37.42 (–£75.46 to £0.61) 0.054
record keeping

Travel (duration) £144.52 (247.62) £124.68 (194.78) £19.83 (–£54.09 to £93.75) 0.597

Travel (mileage) £68.97 (124.95) £57.07 (97.60) £11.90 (–£25.30 to £49.11) 0.528
Other £13.45 (32.20) £19.75 (56.39) –£6.30 (–£21.53 to £8.94) 0.415

Extra time associated to £2.30 (11.19) £0.28 (2.32) £2.02 (–£0.66 to £4.70) 0.138
‘not attended’ sessions
(e.g. waiting time, phone
call, etc.)
Reward £3.96 (0.49)b £4.22 (0.48)b –£0.26 (–£1.77 to £1.25) 0.727

Parking £0.03 (0.24) £0 £0.03 (–£0.03 to £0.08) 0.319

b b
Treatment total cost £2124.46 (83.06) £1891.30 (87.14) £233.16 (–£6.81 to £473.92) 0.054
a Time delivering treatments (CCBT, MCBT/NDC, MCI/FH) was cost at the therapist client contact hourly rate, while the
other therapist’s time was cost at the therapist standard hourly rate.
b Standard error in parentheses, as variable is multiply imputed or is derived from other multiply imputed variables.

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
65
addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
Park, Southampton SO16 7NS, UK.
 ECONOMIC EVALUATION

Cost of additional health, personal social and non-NHS services

The total cost variable for use in the CUA comparing CCBT + MCBT with CCBT and CCBT + MCI with
CCBT was derived using the treatment costs only. Limited data were available from the additional health
and social service use patient diaries and three monthly resource use questionnaires (see Appendix 3,
Tables 92–115) owing to small numbers completed (reported in Appendix 3, Table 91). The results from
these analyses provide an indication of the broad health and social care resources used by this group.
Tables 81 and 82 report a summary of these results for CCBT + MCBT versus CCBT and for CCBT + MCI
versus CCBT. Further, detailed sensitivity analyses using chained equations to impute missing data will
consider this wider societal perspective. The analyses will include these health and social care resources
and costs beyond the resources/cost of the treatment, as well as resource use/cost from other sectors of
the economy (e.g. education). Furthermore, additional information on productivity loss (i.e. days off school
for children, and days off work and usual activities for mothers) will be included in these sensitivity
analyses (see Appendix 3, Tables 112–115).

TABLE 81 Cost of other health and social care resources and other non-NHS services: child, mother and overall
(available data only) – CCBT + MCBT vs. CCBT

CCBT + MCBT, CCBT, Mean differences:

Cost n mean (SD) n mean (SD) CCBT + MCBT – CCBT (95% CI) p-value

Child

Baseline to 35 £191.10 (281.97) 32 £148.01 £43.10 (–£99.46 to £185.66) 0.548

assessment 1B (302.32)

Assessment 1B to 17 £202.02 (648.96) 20 £121.76 £80.25 (–£265.66 to £426.18) 0.641

assessment 2 (369.93)

Assessment 2 to 32 £161.53 (267.83) 30 £385.78 –£224.25 (–£605.70 to £157.19) 0.244

assessment 3 (1043.20)

Assessment 3 to 23 £103.47 (158.66) 30 £327.45 –£223.98 (–£721.84 to £273.88) 0.371

assessment 4 (1178.54)

Total over 12 months 54 £327.26 (546.50) 51 £560.16 –£232.90 (–£742.72 to £276.90) 0.367
(child) (1803.80)

Mother

Baseline to 35 £145.32 (189.04) 32 £223.66 –£78.33 (–£237.89 to £81.22) 0.330

assessment 1B (429.56)
Assessment 1B to 17 £202.95 (272.91) 20 £382.62 –£179.66 (–£625.18 to £265.85) 0.418
assessment 2 (867.47)

Assessment 2 to 32 £194.44 (323.03) 30 £313.20 –£118.76 (–£453.43 to £215.91) 0.481

assessment 3 (886.12)

Assessment 3 to 23 £299.35 (537.12) 30 £206.27 £93.09 (–231.09 to 417.27) 0.567

assessment 4 (614.93)

Total over 12 months 54 £400.81 (622.99) 51 £595.95 –£195.13 (–£758.53 to £368.25) 0.494
(mother) (1987.14)
Child and mother
Total over 12 months 54 £728.07 (860.19) 51 £1156.11 –£428.048 (–£1453.25 to £597.16) 0.410
(child and mother) (281.97)

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 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

TABLE 82 Cost of other health and social care resources and other non-NHS services: child, mother and overall
(available data only) – CCBT + MCI vs. CCBT

CCBT + MCI, CCBT, Mean differences:

Cost n mean (SD) n mean (SD) CCBT + MCI – CCBT (95% CI) p-value

Child

Baseline to assessment 1B 47 £172.17 32 £148.01 £24.16 (–£138.91 to £187.24) 0.769

(390.05) (302.32)

Assessment 1B to 25 £120.25 20 £121.76 –£1.51 (–£212.19 to £209.17) 0.989

assessment 2 (330.03) (369.93)

Assessment 2 to 31 £89.51 30 £385.78 –£296.28 (–£676.18 to £83.63) 0.124

assessment 3 (169.73) (1043.20)

Assessment 3 to 23 £132.54 30 £327.45 –£194.90 (–£698.31 to £308.51) 0.441

assessment 4 (258.41) (1178.54)

Total over 12 months 60 £282.03 51 £560.16 –£278.139 (–£767.21 to £210.93) 0.262

(child) (586.32) (1803.80)

Mother

Baseline to assessment 1B 47 £122.15 32 £223.66 –£101.512 (–£250.56 to £47.54) 0.179

(232.82) (429.56)
Assessment 1B to 25 £129.19 20 £382.62 –£253.42 (–£621.46 to £114.61) 0.172
assessment 2 (259.35) (867.47)

Assessment 2 to 31 £82.67 30 £313.20 –£230.53 (–£552.31 to £91.25) 0.157

assessment 3 (127.86) (886.12)

Assessment 3 to 23 £151.26 30 £206.27 –£55.01 (–£324.56 to £214.55) 0.684

assessment 4 (213.60) (614.93)

Total over 12 months 60 £250.21 51 £595.95 –£345.74 (–£861.08 to £169.59) 0.186

(mother) (311.15) (1987.14)
Child and mother

Total over 12 months 60 £311.15 51 £1156.11 –£623.88 (–£1595.28 to £347.52) 0.206

(child and mother) (814.58) (281.97)

Quality-adjusted life-years
Table 83 reports the results of the child EQ-5D utility values and QALYs for CCBT + MCBT versus CCBT.
There are no statistically significant differences in QALYs at 12 months.

Table 84 reports the results of the child EQ-5D utility values and QALYs for CCBT + MCI versus CCBT.
There are no statistically significant differences in QALYs at 12 months.

Table 85 reports the results of the mother EQ-5D utility values and QALYs for CCBT + MCBT versus CCBT.
There are no statistically significant differences in QALYs at 12 months.

Table 86 reports the results of the mother EQ-5D utility values and QALYs for CCBT + MCI versus CCBT.
There are no statistically significant differences in QALYs at 12 months.

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
67
addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
Park, Southampton SO16 7NS, UK.
 ECONOMIC EVALUATION

TABLE 83 Child EQ-5D utility values and QALYs gained: CCBT + MCBT vs. CCBT

CCBT + MCBT (n = 69), CCBT (n = 71), Mean differences:

Time of assessment mean (SE) mean (SE) CCBT + MCBT – CCBT (95% CI) p-value

EQ-5D utility values

Baseline 0.706 (0.028) 0.684 (0.036) 0.022 (–0.070 to 0.113) 0.641

Assessment 1B 0.727 (0.030) 0.773 (0.034) –0.046 (–0.135 to 0.042) 0.300

Assessment 2 0.798 (0.028) 0.862 (0.028) –0.065 (–0.144 to 0.015) 0.108

6-month follow-up 0.823 (0.033) 0.840 (0.034) –0.018 (–0.116 to 0.081) 0.723

12-month follow-up 0.821 (0.038) 0.862 (0.034) –0.042 (–0.150 to 0.067) 0.440

QALYs gained

Baseline to 0.110 (0.004) 0.112 (0.004) –0.002 (–0.013 to 0.009) 0.741

assessment 1B

Assessment 1B to 0.117 (0.004) 0.126 (0.004) –0.009 (–0.019 to 0.002) 0.097

assessment 2

Assessment 2 to 0.156 (0.005) 0.164 (0.005) –0.008 (–0.023 to 0.007) 0.291

6 months
6–12 months 0.411 (0.015) 0.426 (0.015) –0.015 (–0.059 to 0.030) 0.508

Total over 12 months 0.794 (0.022) 0.827 (0.024) –0.033 (–0.101 to 0.035) 0.332
SE, standard error.

TABLE 84 Child EQ-5D utility values and QALYs gained: CCBT + MCI vs. CCBT

CCBT + MCI (n = 71), CCBT (n = 71), Mean differences:

Time of assessment mean (SE) mean (SE) CCBT + MCI – CCBT (95% CI) p-value

EQ-5D utility values

Baseline 0.729 (0.036) 0.684 (0.036) 0.045 (–0.058 to 0.147) 0.393

Assessment 1B 0.798 (0.026) 0.773 (0.034) 0.025 (–0.059 to 0.109) 0.559

Assessment 2 0.867 (0.023) 0.862 (0.028) 0.004 (–0.068 to 0.076) 0.904

6-month follow-up 0.897 (0.023) 0.840 (0.034) 0.057 (–0.026 to 0.139) 0.175

12-month follow-up 0.864 (0.031) 0.862 (0.034) 0.001 (–0.083 to 0.086) 0.973

QALYs gained

Baseline to 0.118 (0.004) 0.112 (0.004) 0.005 (–0.006 to 0.017) 0.370

assessment 1B

Assessment 1B to 0.128 (0.003) 0.126 (0.004) 0.002 (–0.007 to 0.012) 0.637

assessment 2

Assessment 2 to 0.170 (0.004) 0.164 (0.005) 0.006 (–0.007 to 0.018) 0.358

6 months

6–12 months 0.440 (0.012) 0.426 (0.015) 0.015 (–0.021 to 0.050) 0.424
Total over 12 months 0.855 (0.018) 0.827 (0.024) 0.028 (–0.030 to 0.086) 0.342
SE, standard error.

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 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

TABLE 85 Mother EQ-5D utility values and QALYs gained: CCBT + MCBT vs. CCBT

CCBT + MCBT (n = 69), CCBT (n = 71), Mean differences:

Time of assessment mean (SE) mean (SE) CCBT + MCBT – CCBT (95% CI) p-value

EQ-5D utility values

Baseline 0.833 (0.022) 0.816 (0.025) 0.017 (–0.050 to 0.084) 0.613

Assessment 1B 0.848 (0.022) 0.810 (0.036) 0.038 (–0.044 to 0.120) 0.358

Assessment 2 0.865 (0.026) 0.842 (0.030) 0.022 (–0.060 to 0.103) 0.597

6-month follow-up 0.861 (0.026) 0.855 (0.026) 0.007 (–0.069 to 0.082) 0.860

12-month follow-up 0.824 (0.030) 0.841 (0.034) –0.017 (–0.101 to 0.067) 0.689

QALYs gained

Baseline to 0.129 (0.003) 0.125 (0.004) 0.004 (–0.005 to 0.014) 0.384

assessment 1B

Assessment 1B to 0.132 (0.003) 0.127 (0.004) 0.005 (–0.006 to 0.015) 0.381

assessment 2

Assessment 2 to 0.166 (0.004) 0.163 (0.004) 0.003 (–0.011 to 0.016) 0.690

6 months
6–12 months 0.421 (0.011) 0.424 (0.013) –0.003 (–0.036 to 0.031) 0.878

Total over 12 months 0.848 (0.019) 0.839 (0.023) 0.009 (–0.050 to 0.068) 0.763
SE, standard error.

TABLE 86 Mother EQ-5D utility values and QALYs gained: CCBT + MCI vs. CCBT

CCBT + MCI (n = 71), CCBT (n = 71), Mean differences:

Time of assessment mean (SE) mean (SE) CCBT + MCI – CCBT (95% CI) p-value

EQ-5D utility values

Baseline 0.799 (0.028) 0.816 (0.025) –0.017 (–0.091 to 0.058) 0.655

Assessment 1B 0.822 (0.027) 0.810 (0.036) 0.012 (–0.079 to 0.104) 0.789

Assessment 2 0.843 (0.027) 0.842 (0.030) 0.0003 (–0.082 to 0.083) 0.995

6-month follow-up 0.829 (0.026) 0.855 (0.026) –0.026 (–0.097 to 0.045) 0.474

12-month follow-up 0.857 (0.029) 0.841 (0.034) 0.016 (–0.067 to 0.100) 0.696

QALYs gained

Baseline to 0.125 (0.004) 0.125 (0.004) –0.0003 (–0.011 to 0.010) 0.950

assessment 1B

Assessment 1B to 0.128 (0.004) 0.127 (0.004) 0.001 (–0.011 to 0.013) 0.869

assessment 2

Assessment 2 to 0.161 (0.004) 0.163 (0.004) –0.002 (–0.015 to 0.010) 0.705

6 months

6–12 months 0.422 (0.012) 0.424 (0.013) –0.002 (–0.036 to 0.032) 0.893

Total over 12 months 0.835 (0.021) 0.839 (0.023) –0.004 (–0.065 to 0.057) 0.894

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
69
addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
Park, Southampton SO16 7NS, UK.
 ECONOMIC EVALUATION

Cost–utility analysis
Table 87 and Figures 8–10 report the results of the CUA from a health-care perspective for CCBT + MCBT
compared with CCBT. The bootstrapped ICERs for this comparison are shown in the cost-effectiveness
plane in Figure 8. With higher mean costs (albeit statistically insignificant) and lower mean utility (albeit
statistically insignificant) differences between the groups, Figure 8 reveals that, given current thresholds
for commonly accepted levels of cost-effectiveness (£20,000–30,000), CCBT + MCBT is not likely to
be a cost-effective alternative to CCBT. The CEAC shown in Figure 9 reveals that the probability that
CCBT + MCBT will be cost-effective in comparison with CCBT is < 10%. The NMB curve (see Figure 10)
confirms that CCBT + MCBT confers no monetary benefit over CCBT for a broad range of societal
willingness-to-pay thresholds and would not be deemed cost-effective given commonly accepted
threshold values representing value for money.

TABLE 87 Cost–utility analysis (health service perspective): ITT approach – CCBT + MCBT vs. CCBT

CUA results CCBT + MCBT (n = 69), mean (SE) CCBT (n = 71), mean (SE)

Cost of intervention £2124.85 (84.98) £1891.30 (87.14)

QALY gain 0.794 (0.022) 0.827 (0.024)

Incremental cost (95% CI) £233.55 (–£6.81 to £473.92)

Incremental QALY gain (95% CI) –0.033 (–0.101 to 0.035)

ICER, incremental cost per QALY gain –£7077

(95% CI) bootstrap method Lower limit, £12,373; upper limit, –£91

(95% CI) Fieller’s method Lower limit, £10,000; upper limit, £187

NMB for WTP = £20,000 –0.033 × £20,000 – £233.55 = –£893.55

NMB for WTP = £30,000 –0.033 × £30,000 – £233.55 = –£1223.55

SE, standard error; WTP, willingness to pay.

654.87
Difference in cost (£)

368.76 Replicates
LL
PE_line
UL

82.64

–203.46
–0.128 –0.085 –0.042 0.001 0.045
Difference in effect

FIGURE 8 Cost-effectiveness plane showing bootstrapped replicates of the ICER: CCBT + MCBT vs. CCBT. LL, lower
limit; PE, point estimate; UL, upper limit.

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 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

1.00

0.75
% acceptable

0.50

0.25

0.00
0 25 50 75 100 125
Willingness to pay (£000)

FIGURE 9 Cost-effectiveness acceptability curve showing the probability that the intervention is cost-effective at
different willingness-to-pay thresholds: CCBT + MCBT vs. CCBT.

0
NMB (£000)

LL
NMB
UL

–5

–10

0 25 50 75 100 125
Willingness to pay (£000)

FIGURE 10 Net monetary benefit curve and limit curves: CCBT + MCBT vs. CCBT. LL, lower limit; UL, upper limit.

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
71
addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
Park, Southampton SO16 7NS, UK.
 ECONOMIC EVALUATION

Table 88 and Figures 11–13 present the results of the CUA from a health-care perspective for CCBT + MCI
compared with CCBT. The bootstrapped ICERS for this comparison are shown in the cost-effectiveness
plane in Figure 11. With higher mean costs (albeit statistically insignificant) and higher mean utility (albeit
statistically insignificant) differences between the groups, Figure 11 reveals that, given the distribution of
the ICERS, CCBT + MCI is highly likely to be a cost-effective alternative to CCBT. The CEAC shown in
Figure 12 reveals that, given current NICE thresholds for accepted levels of willingness to pay for an extra
QALY (£20,000–30,000), the probability that CCBT + MCI will be cost-effective in comparison with CCBT is
around 75%. The NMB curve (see Figure 13) confirms that CCBT + MCI confers additional monetary
benefit over CCBT alone and would be deemed a cost-effective alternative given commonly accepted
threshold values representing value for money.

TABLE 88 Cost–utility analysis (health service perspective): ITT approach – CCBT + MCI vs. CCBT

CUA results CCBT + MCI (n = 71), mean (SE) CCBT (n = 71), mean (SE)

Cost of intervention £2124.46 (83.06) £1891.30 (87.14)

QALYs 0.855 (0.018) 0.827 (0.024)

Incremental cost (95% CI) £233.16 (–£6.81 to £473.92)

Incremental benefit, QALY gain (95% CI) 0.028 (–0.030 to 0.086)

ICER, incremental cost per QALY gain £8327

(95% CI) bootstrap method Lower limit, –£173; upper limit, –£11,021
(95% CI) Fieller’s method Lower limit, –£95; upper limit, –£8881

NMB for WTP = £20,000 0.028 × £20,000 – £233.16 = £326.84

NMB for WTP = £30,000 0.028 × £30,000 – £233.16 = £606.84

SE, standard error; WTP, willingness to pay.

769.54
Difference in cost (£)

457.18 Replicates
LL
PE_line
UL

144.82

–167.53
–0.061 –0.011 0.039 0.089 0.140
Difference in effect

FIGURE 11 Cost-effectiveness plane showing bootstrapped replicates of the ICER: CCBT + MCI vs. CCBT. LL, lower
limit; PE, point estimate; UL, upper limit.

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 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

1.00

0.75
% acceptable

0.50

0.25

0.00
0 25 50 75 100 125
Willingness to pay (£000)

FIGURE 12 Cost-effectiveness acceptability curve showing the probability that the intervention is cost-effective at
different willingness-to-pay thresholds: CCBT + MCI vs. CCBT.

10

5
LL
NMB (£000)

NMB
UL

–5

0 25 50 75 100 125
Willingness to pay (£000)

FIGURE 13 Net monetary benefit curve and limit curves: CCBT + MCI vs. CCBT. LL, lower limit; UL, upper limit.

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
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addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
Park, Southampton SO16 7NS, UK.
 ECONOMIC EVALUATION

Sensitivity analysis
A key question of uncertainty in the cost-effectiveness analysis related to the impact of reducing the
treatment costs of non-specific interventions. Hence, sensitivity analysis was conducted by setting
the treatment costs related to non-specific interventions to zero. Treatment costs related to non-specific
interventions included NDC and a generic FH control intervention delivered to balance groups for therapist
contact. Although this analysis was conducted with the intention to reflect what would happen in reality
if the interventions were adopted in current practice, it relied on the strong assumption that the non-specific
interventions had no impact at all on the child anxiety outcomes. By increasing the cost difference between
interventions and control, but maintaining the difference in effects invariant (as counterfactual outcomes
in absence of non-specific interventions could not be measured), no evidence was found that either
CCBT + MCBT or CCBT + MCI would offer any added value for money in improving child anxiety outcomes
beyond what was already suggested in the primary analyses. Detailed results are reported in Appendix 3,
Tables 116 and 117, and Figures 14–19.

Further sensitivity analysis will be developed by altering other key assumption to explore their
consequences for the results at 12 months follow-up. In particular, an exploration of the incorporation of
broader societal impacts and of the combined child and maternal QALYs on the cost-effectiveness results
will be carried out.

Limitations of the data

The high level of missing data in the follow-up health and social care resource use beyond the treatment
costs is a limitation for this economic evaluation. If the health and personal social service costs reported for
the CCBT + MCBT versus CCBT comparison were representative of this population and included in the ICER,
as they typically would be, the costs in the CCBT arm would increase by £428, thereby placing CCBT + MCBT
into the lower cost/lower effectiveness zone of the cost-effectiveness plane (south west) and a different
scenario to the cost-ineffective scenario arising when treatment only costs were included in the ICER. If the
health and social care resources reported for the CCBT + MCI versus CCBT comparison were representative
of this population and included in this analysis, the costs in the control arm would increase by £624. This
would have placed the CCBT + MCI arm in the realms of being highly cost-effective (south-east quadrant of
the cost-effectiveness place), that is dominating the CCBT arm and being both less costly and more effective,
a clear win–win scenario. Another limitation of the data was the high percentage of missing data. This was
dealt with using appropriate data imputation techniques; however, imputation cannot account for potentially
non-random reasons for missing data.

Discussion

The aim of the economic evaluation was to assess the cost-effectiveness of the CCBT + MCBT and
CCBT + MCI treatment arms in relation to the CCBT treatment arm from a health service perspective.
The economic analyses aligned with the primary aim of the trial, namely to evaluate whether or not CCBT
could be improved by the addition of (i) treatment of maternal anxiety disorders (MCBT), or (ii) treatment
focused on maternal responses (MCI). Combining the total treatment costs with maternal and child QALYs
revealed that, within commonly accepted levels of value for money (i.e. £20,000–30,000 per extra QALY
gained), CCBT + MCBT was not likely to be a cost-effective alternative to CCBT. However, combining the
total treatment costs with child QALYs revealed that in the comparison of the CCBT + MCI with CCBT
treatment arms, the CCBT + MCI treatment arm was highly likely to be a cost-effective alternative to the
CCBT arm. A limitation of these analyses, however, was that the resource use and costs of additional health
and personal social services, beyond the current treatment costs, were not included in the primary analyses
owing to very small sample sizes for these data components. Insufficient statistical power meant that
conclusions could not be drawn about the impact of these additional costs on the overall cost-effectiveness.
These additional data, however, do provide insights about the type and range of services this group of
children and mothers use. Children undergoing treatment for anxiety disorders can be seen to be accessing
a broad range of services beyond treatment from GPs, including social workers, psychologists, psychiatrists,

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 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

education welfare officers, family liaison officers, teachers, paediatricians, audiologists, ophthalmology,
accident and emergency (A&E), dieticians, physiotherapists, mental health workers and ‘other services’.
Notwithstanding the limited evidence these small sample sizes convey, comparisons of CCBT + MCBT and
CCBT + MCI with the CCBT treatment arm reveal increasing costs prevalent in the CCBT arm in the majority
of the assessment periods. Furthermore, counting the number of services accessed by each group it can be
seen that overall participants in the CCBT arm were accessing approximately one-third more services than
those in the CCBT + MCBT and CCBT + MCI arms. In addition, the total costs are always higher in the CCBT
arm for both comparisons. If these differences translated into actual differences then this would only
increase the likelihood of the CCBT + MCBT and CCBT + MCI arms being more cost-effective than the CCBT
arm. It is only by replicating these data collection exercises with larger samples that these results can be
confirmed or refuted. On a cautionary note, however, it is important to outline that increased use of services
may not represent an inferior quality-of-life outcome owing to the benefits of increased awareness about
the health and well-being advantages of accessing additional services.

Broader impacts on other sectors, including impacts on education, employment and impacts on leisure
time including time off school for children and time off work and usual activities for their mothers,
were also presented but not included in the primary analyses. Further analyses will explore the impact of
these effects on a broader societal perspective.

Conclusions

These CUAs have shown that when adopting a health service perspective, only the addition of MCI to
standard CCBT is highly likely to represent a cost-effective use of resources for these mother/child pairs
within commonly accepted thresholds of cost-effectiveness. Further, analyses reveal that when adopting a
health service perspective only the addition of MCBT to standard CCBT is unlikely to be a cost-effective
use of resources for these mother/child pairs. However, the latter result should be interpreted with caution
because of the high percentage of missing data in some variables which, despite being dealt with using
appropriate imputation techniques, may still be viewed as a shortcoming. However, further analysis
incorporating the additional health and social care costs has indicated that, depending on the
representativeness of these data, there are possible improvements in the cost-effectiveness of both
CCBT + MCBT and CCBT + MCI depending on the assumptions made about these costs. Further analysis
of the data exploring inclusion of the additional health and personal social service costs and employment
and educational impacts using multiple imputations within sensitivity analyses may provide further
insight to the cost-effectiveness of these interventions. This economic evaluation provides insight to the
broad range of services accessed by this client group, hence it is recommended that future economic
evaluations in this area incorporate data collection on this full range of services to fully capture the impact
of new interventions.

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
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addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
Park, Southampton SO16 7NS, UK.
 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

Chapter 5 Discussion and conclusions

Summary of findings

Children with anxiety disorders whose mothers are also highly anxious have been shown to have a
poorer response to treatment than those whose mothers are not anxious,9,100 yet the impact on children
of treating the maternal anxiety has been unclear. Further, the clinical impact on children with anxiety
disorders of targeting potentially anxiogenic maternal behaviours has not previously been evaluated
systematically. The current study set out to address both these issues in a large RCT.

There was some evidence that the MCBT and MCI treatments were successful in altering the maternal factors
which they were designed to address. Specifically, MCBT conferred short-term benefits in maternal recovery
from primary diagnoses. However, by the post-treatment assessment, when children in all treatment arms had
received CCBT, mothers in all arms had experienced a good level of recovery from their primary disorder and
differences between treatment arms were no longer apparent. It is important to note that there were no
significant differences between treatment arms on maternal-reported symptoms of anxiety at any time
point. For the CCBT + MCI treatment arm there was evidence of change in maternal overprotection and
expectations relating to a lack of child coping with challenge. There were no differences between treatment
arms in change in other potentially anxiogenic parenting responses (such as expressed anxiety and
positive behaviours).

Despite the success in changing some aspects of maternal anxiety and parenting responses, adding neither
treatment of maternal anxiety (MCBT) nor treatment of maternal responses (MCI) conferred a significant
benefit on children on the basis of the primary child treatment outcomes. Although both adjunct treatments
achieved higher child recovery and global improvement rates post treatment than the group in which neither
maternal anxiety nor potentially anxiogenic parenting received specific therapeutic attention, the advantages
were neither statistically significant nor consistent across treatment arms and outcome measures.

There was some evidence of an advantage for the CCBT + MCI treatment arm on the primary outcomes at
the 6-and 12-month follow-up assessments, but this did not reach statistical significance. There was a
significant advantage of CCBT + MCI over CCBT on change in child anxiety severity at the 6-month
follow-up, and a similar pattern existed at the 12-month follow-up (although it was no longer statistically
significant). There was a general lack of significant differences between treatment arms on child-,
mother- and teacher-reported anxiety symptom questionnaires. Where statistically significant differences
did exist, these were contrary to expectations, with children in the CCBT group reporting a greater reduction
in symptoms of anxiety and low mood than children in the CCBT + MCI arm at the post-treatment
assessment. In contrast, mothers in the CCBT + MCI arm reported a greater reduction in child conduct
problems at the 12-month follow-up assessment than mothers in the CCBT arm.

The secondary research questions considered whether or not improvement in child anxiety was significantly
associated with change in (i) maternal anxiety, and (ii) maternal parenting responses. No significant
associations were found between change in maternal anxiety and change in child anxiety symptoms,
severity or improvement at the mid-treatment, post-treatment and 6-month follow-up assessments.
Contrary to expectations, greater change in maternal anxiety symptoms was associated with less change
in the severity of the child’s primary anxiety diagnosis. It is important to note that a large number of
correlations were conducted to examine this research question and the lack of a consistent pattern
of results highlights the fact that no clear conclusions can be drawn. In relation to maternal parenting
responses, significant associations were found between change in maternal behaviours and change in child
anxiety, most commonly for maternal overprotection. Specifically, and contrary to expectations, a greater
increase in overprotection was associated with a greater reduction in the severity of the child’s primary

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
77
addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
Park, Southampton SO16 7NS, UK.
 DISCUSSION AND CONCLUSIONS

anxiety diagnosis post treatment and global improvement at both the post-treatment and the 6-month
follow-up assessments. These indices are both assessor rater; when child symptom ratings were used the
opposite pattern was found, with a greater reduction in maternal overprotection being associated with
greater reduction in child anxiety symptoms. The difference in the pattern of findings according to who is
reporting on child anxiety is interesting and warrants further investigation, but for now clear conclusions
about mechanisms of change cannot be drawn.

Economic evaluation

The CUAs demonstrated that, when adopting a health service perspective, the addition of MCI to standard
CCBT is highly likely to represent a cost-effective use of resources for these mother/child pairs within
commonly accepted thresholds of cost-effectiveness. Further, analyses reveal that when adopting a health
service perspective the addition of MCBT to standard CCBT is unlikely to be a cost-effective use of resources
for these mother/child pairs. Those cost-effectiveness results should be interpreted with caution owing to the
high percentage of missing data on some variables which, despite being dealt with using appropriate
imputation techniques, may still be viewed as a shortcoming. Furthermore, analysis incorporating the
additional health and social care costs has indicated that, depending on the representativeness of these
data, there are possible improvements in the cost-effectiveness of both CCBT + MCBT and CCBT + MCI
depending on the assumptions made about these costs. Further analysis of the data exploring inclusion of
the additional health and personal social service costs and employment and educational impacts using
multiple imputations within sensitivity analyses may provide further insight to the cost-effectiveness of these
interventions. The economic evaluation provides insight into the broad range of services accessed by this
client group; hence, it is recommended that future economic evaluations in this area incorporate data
collection on this full range of services when evaluating new interventions.

Strengths and limitations

The study had several notable strengths, including the referred clinical sample, the use of reliable, blind
raters to make assessments of child and maternal anxiety and maternal behaviours before and after
treatment, and a design which allowed for isolating the effects of specifically targeting maternal anxiety
and parenting responses. A further strength of the study was the inclusion of non-specific interventions
designed to balance therapist contact. However, the data collected for health economic analyses indicated
that therapist contact did not end up entirely balanced within each phase of treatment. Most notably,
more therapist time was spent delivering the eight sessions of MCBT treatment than the eight sessions of
NDC that were delivered in the CCBT arm. Similarly, the MCI treatment took more time to deliver than the
FH-oriented control. In both cases this may have resulted from the more directive treatment manuals in
the MCBT and MCI treatments requiring longer sessions, or from therapist difficulties in maintaining
engagement in the NDC and FH treatments so moving through the material more quickly. This suggestion
is consistent with the fact that the highest rate of dropout was found during the eight-session NDC
phase of treatment. Despite these differences, the overall time and cost of interventions across the entire
treatment period was not significantly different across arms, supporting a good balance overall in therapist
contact across treatment arms.

The strengths of the study need to be considered in the light of various other limitations. Although we
allowed for 20% loss to follow-up, by the 1-year post-treatment assessment retention was down to 61%
in the CCBT condition. This limits the conclusions that can be drawn about differences between treatment
conditions in the longer term. Although there were no clear baseline differences between completers
and those who dropped out, it is of concern that the greatest amount of dropout occurred during the
eight-session maternal counselling phase. Therefore, this form of intervention appears not to have been an
acceptable treatment approach for some families. This finding presents a challenge for future research;
the inclusion of non-specific interventions presents a conservative test of the specific effects of particular

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interventions but requires the delivery of credible, alternative interventions. Whether longer-term dropouts
over-represented those with good or bad treatment outcomes cannot be determined, although the
sensitivity analyses that were conducted suggest that this was not the case. Our impression was that, in
some cases, those that dropped out from follow-up assessments did so because they felt that their child
had made a good recovery and had ‘moved on’ (and so did not want them to have to take part in a long
diagnostic assessment). Future studies might benefit from an abridged follow-up assessment which places
a minimal burden on participants. The degree to which long-term outcome was also influenced by
involvement with help seeking elsewhere is also unclear. Although families agreed not to initiate any other
treatment during the course of the intervention, they may have sought help elsewhere during the
follow-up period. However, as indicated in the economic analyses (see Appendix 3, Tables 91–111), use of
other resources was low across all treatment arms.

The lack of additional health and social care resource use beyond the treatment costs is a limitation for the
economic evaluation presented here. Unfortunately there was a large amount of missing data on this
measure which precluded its inclusion in these analyses. However, preliminary analysis incorporating the
limited data available on the additional health and social care costs has indicated that, depending on
the representativeness of these data, there are possible improvements in the cost-effectiveness of both
CCBT + MCBT and CCBT + MCI depending on the assumptions made about these costs. Further analysis of
the data exploring inclusion of the additional health and personal social service costs and employment and
educational impacts using multiple imputations within sensitivity analyses may provide further insight to
the cost-effectiveness of these interventions.

Other limitations include the relatively restricted demographic characteristics of the participating group, who
were predominantly of non-minority ethnicity and relatively high socioeconomic status (SES), although this
was lower than in a comparable trial on the basis of parent education.19 Our study population also had
somewhat higher rates of child- and parent-rated anxiety levels than in similar studies.19 In terms of marital
status, the population was representative of the wider population.101 We elected to focus on middle
childhood (ages 7–12 years) and intervening with mothers as a methodological expediency as it is likely that
the nature of parental influences on child anxiety varies with child age102,103 and parent gender;34 however, as
a result, the findings cannot be generalised to young children or adolescents or to interventions with fathers
or other caregivers. The extent to which characteristics of other parental figures (e.g. paternal anxiety and
parenting responses) moderate treatment outcomes warrants further examination. In our trial each phase of
treatment was delivered by a different therapist, this meant that there was a very large number of different
combinations of therapists (116 combinations) which precluded us from examining therapist effects.

The study also included children and mothers with a broad range of anxiety disorders. There is emerging
evidence that generic treatment approaches, of the sort provided in the study, may be more beneficial for
some child anxiety disorders than others104 and that particular potentially anxiogenic parental responses may
be disorder specific.64,105 Both of these sets of findings suggest that further work needs to be done which
takes account of the precise form of parental and child anxiety, as well as particular forms of parenting
responses. The inclusion of mothers with a broad range of disorders also meant that it was most appropriate
for a transdiagnostic anxiety treatment to be delivered. Although there is evidence for the effectiveness of
this approach (both here and in previous studies),38 it is unclear if disorder-specific treatments would have
conferred greater benefits in terms of maternal anxiety. Furthermore, anxiety disorders are commonly
comorbid with depression;32 the extent to which maternal depression moderates treatment outcomes in the
context of maternal anxiety disorders warrants further attention. Finally, although we recruited a referred
clinical population, their experience of treatment will have been very different from routine child mental
health services because of the intensive research assessments and the adjunct interventions that were
essential for our research purposes. Further insights in to the experiences of patients and therapists
participating in this trial would be of value.

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
79
addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
Park, Southampton SO16 7NS, UK.
 DISCUSSION AND CONCLUSIONS

Interpretation of results

The findings suggest that adding specific interventions targeting maternal anxiety or the MCIs to individual CBT
for children with anxiety disorders in the context of maternal anxiety disorder do not confer significant benefits
in terms of child outcomes when compared with individual CBT (supplemented with non-specific therapist
support); although some cost–benefit may obtain from the addition of an intervention to target the MCI.

Our findings, in relation to the treatment of parental anxiety disorder, are consistent with those obtained
in a recent study by Hudson and colleagues.19 Their study also specifically focused on children with anxiety
disorders who had a parent with an anxiety disorder, and they also failed to find a significant benefit of
the addition of parental anxiety management to CCBT. The findings also run contrary to the idea that
changing parental responses is necessary for successful treatment of child anxiety disorder in the context of
parental anxiety disorder.23 Notably, however, the CCBT treatment arm in the current study performed
considerably better than expected: immediately post treatment, 48% of children were free of their primary
anxiety disorder, and 64% were ‘much’ or ‘very much’ improved; a year after treatment, 72% were free of
their primary diagnosis and 77% were ‘much’/‘very much’ improved. These outcomes are particularly
notable given the relatively brief nature of the CCBT intervention.106 They are also higher than the 33% of
children (with a parent with an anxiety disorder) who were free of their primary anxiety disorder in the
study reported by Hudson and colleagues.19 Indeed, the success rates reported here are similar to those
found from more intensive (14-session) CBT for children with anxiety disorders, regardless of parental
anxiety disorder status, where 60% and 72% were ‘much’/’very much’ improved at post treatment55
and 6-month follow-up,107 respectively. The lack of consistent differences between groups on clinical
outcomes and the failure to find consistent, significant associations between the hypothesised mechanisms
of change and child outcomes, may suggest that the association that has been commonly found between
maternal anxiety disorder and child treatment outcomes may be the result of some third factor, for
example other stressors experienced by the family, or shared associations with particular child or maternal
comorbidities. The fact that we obtained higher child outcomes than expected following CCBT suggests
that it is possible that this third factor variable was addressed to some extent by the generic support
received by all mothers in this trial.

One consideration in making sense of the lack of main effects of the two active adjunct interventions
(MCI/MCBT) is statistical power, given the higher than anticipated success rate on the CCBT arm. However,
the extent of differences found between our treatment arms was below our a priori criteria for clinical
significance (30% more children free of their anxiety diagnoses). The unexpectedly high rate of recovery
within the CCBT group in the current study is unlikely to be a function of particular features of our sample,
as our study population was a referred sample with systematically confirmed anxiety diagnoses, comparable
to other clinic samples in the literature. One possible explanation may lie in the potential added value of the
non-specific interventions. These both provided some level of parental support. Although the design used for
the current study was appropriate for determining whether or not the MCBT and MCI interventions conferred
specific benefits, controlling for therapist contact time using non-specific interventions is a conservative
approach and the effects of the non-specific treatments are unclear. The absence of a significant main effect
of either CCBT + MCBT or CCBT + MCI also needs to be considered in the light of the degree to which the
adjunctive interventions were successful in altering their respective targets. In the one previous study that
assessed the impact of adding CBT for parental anxiety disorders to CBT for child anxiety disorders,12 the
failure to find differences in child outcomes was attributed to the fact that the parental CBT did not confer a
benefit in terms of reducing parental anxiety compared with when only the children received CBT (i.e. 35.5%
vs. 32.7% of mothers were free of their primary anxiety disorder, respectively). In the current study, a more
intensive CBT intervention was delivered to the mothers and, as predicted, CCBT + MCBT was associated
with a significant reduction in the frequency of maternal anxiety disorder compared with when mothers
received NDC (58.5% vs. 36.5% diagnosis free). However, by the end of the CCBT treatment phase there
were no group differences in maternal anxiety disorder, with all groups showing high rates of recovery from
maternal anxiety disorder (52–66%). The fact that a marked reduction in anxiety disorders across all groups
was found following CCBT is consistent with recent findings indicating that reduction in child anxiety
promotes reduction in parental anxiety.25

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 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

This study is the first of which we are aware to report on observational assessments of parental responses
before-and-after treatment for child anxiety disorders. We were able to rigorously evaluate the extent to
which the MCI intervention successfully altered maternal responses to her child when confronted with a
challenge. These assessments provided evidence that, in terms of a reduction in overprotective behaviours,
the MCI treatment was indeed successful. It is notable that this observation-based finding was confirmed by
maternal self-report data. The MCI intervention was also associated with change in maternal cognitions
associated with confidence in child coping (i.e. reduced predictions regarding child fear and increased
predictions regarding child control). Despite these positive benefits of the MCI intervention, no significant
benefit to child outcomes was conferred on primary outcome measures (although MCI added to CCBT
seemed to represent good value for money). One possible reason for this may be that the changes were not
of sufficient magnitude to be of benefit in terms of the clinical outcomes. Another possibility is that the
factors that did change are not central to the maintenance of child anxiety. Indeed, although scores on
the self-report maternal overprotection scale used have been found to be associated with the development
of child anxiety,108 others have found that they do not discriminate clinically anxious children from their
non-anxious peers.66 It will be important to evaluate whether the association between maternal anxiety
disorder and child treatment outcomes is in fact mediated by other shared factors, for example other stressors
experienced by the family, which might have been addressed to some extent by the generic support received
by all mothers in this trial. It is of interest that no specific benefit was apparent for the MCI intervention on
the measures of maternal expressed anxiety, intrusiveness or positive behaviours. Although it is, of course,
possible that the intervention was ineffective with respect to these dimensions, it is also possible that these
findings reflect a lack of sensitivity of the laboratory-based observational tasks. It is also possible that
these parental behaviours changed equally across groups in response to improvements in child anxiety.13

Although there were no significant differences between treatment arms on the primary outcome measures
at the post-treatment assessment, an advantage for CCBT + MCI was found on indices of change in
anxiety disorders severity and an advantage which approached significance in terms of being free of the
primary anxiety diagnosis at the 6-month follow-up assessment. There was also a trend for an advantage
of CCBT + MCI over the CCBT arm in terms of the proportion of children who were free of all their anxiety
diagnoses. These findings are consistent with the health economic outcomes which suggest that the
CCBT + MCI is a cost-effective use of resources in comparison with the CCBT intervention. As the inclusion
of two non-specific interventions within the CCBT arm would be expected to reduce its cost-effectiveness,
sensitivity analyses were conducted in which zero costs were attributed to the non-specific interventions.
This is a conservative test given that the non-specific interventions might be expected to confer some
benefit to children and mothers, yet there was still evidence to support the cost-effectiveness of the
CCBT + MCI intervention in this context. As noted above, the mechanisms by which CCBT + MCI conferred
a cost–benefit advantage remain unclear.

It is notable that there was also a trend for CCBT + MCBT to have an advantage over CCBT in terms of
general improvement post treatment. However, differences between arms were not consistent across time
points or measures. Thus, although there is a possibility that MCBT helped support the generalisation of
benefits in the short term, this speculation received only weak support.

Some unexpected findings should also be noted. In particular, on the basis of child self-reported anxiety
symptoms, the CCBT + MCBT group did less well than the CCBT group at the post-treatment assessment.
Both the CCBT + MCI and CCBT + MCBT groups also reported less of a reduction in low mood than the
CCBT groups. None of these findings were maintained at the later assessment (although CCBT + MCBT
had the poorest overall outcomes by the 12-month assessment); however, they are surprising given the
content of the child treatment was the same across groups. Whether or not the full course of NDC
(eight sessions) received by the mothers in the CCBT group led to some short-term benefit in terms of
children’s perceptions of their symptoms remains unclear. There were also some unexpected findings in
relation to the secondary research questions, which addressed the extent to which change in maternal
anxiety and parenting responses was associated with change in child anxiety. However, as the pattern of
findings was not consistent across measures and assessment time points no clear conclusions can be drawn.

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
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addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
Park, Southampton SO16 7NS, UK.
 DISCUSSION AND CONCLUSIONS

It is important to note that the sample size for this study was based on providing enough power to assess the
primary outcomes. Other outcomes are secondary and, owing to the large number of tests, the results must
be interpreted with caution.

Implications for health care

l The novel intervention that focused on modifying maternal parenting responses was associated with
some benefit to children and mothers with anxiety disorders, and is likely to be cost-effective (although
the latter result needs to be considered with caution because of the high percentage of missing data
in the economic analyses). Incorporating effective measures to address maternal cognitions and
behaviours when interacting with her child may improve health outcomes for children with anxiety
disorders in the context of maternal anxiety disorder.
l We can be confident that supplementing individual CCBT with CBT to target the maternal anxiety
disorder is unlikely to confer substantial health benefits and is unlikely to be cost-effective (although
the latter result needs to be considered with caution owing to the high percentage of missing data in
the economic analyses). Given the intensity of this intervention and its general lack of effectiveness we
think it is unlikely that supplementing CCBT with this intervention will improve child outcomes.

Implications for future research

l Given that CCBT alone was sufficient for a good number of patients, it is possible that a benefit of the
CCBT + MCI and CCBT + MCBT interventions may be enhanced in particular contexts, for example in
the context of particular maternal or child anxiety disorders or high levels of severity. Future research
that directly addresses these possibilities is warranted.
l The relatively low level of association between change in parental anxiety and responses and child
anxiety may suggest that other factors may account for the modest treatment outcomes typically found
among children with anxiety disorders who have mothers with anxiety disorders (such as genetic or
broader social/environmental factors). Future research is warranted to address these issues.
l The economic evaluation provides insight as to the broad range of services accessed by this client
group, hence it is recommended that future economic evaluations in this area incorporate data
collection on this full range of services when evaluating new interventions.

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 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

Acknowledgements
W e thank the children and their mothers who took part in this research for their help.
We also thank the external members of the Steering Committee [Jonathan Hill (Chair), Sara Ingham,
Pasco Fearon, Paul Stallard and Natasha Connor] and the Data Management and Ethics Committee
[John Geddes (Chair) and Max Parmar] for their support and guidance; Jeff Wood for providing
consultation on the development of the MCI intervention; and Ron Rapee for making the Cool Kids
programme available free of charge. We thank Patricia Howard, Monika Parkinson, Katherine Lawrence,
Kerstin Thirwall, Lorraine Carpenter-Emory, Kate Moberley, Laura Wheen, Sarah Cook, Zoe Hughes,
Katie Adolphus, Polly Waite, Jill Fletcher and Sally Greenfield for assistance in delivering the therapy;
Jenny Crosby, Rebecca O’Grady, Sarah Cook, Amy Corcoran, Ray Percy, Anna Alkozei, Sarah Shildrick,
Ray Percy, Zoe Hughes and Jessica Karalus for assistance with carrying out assessments; Kiri Clarke,
Nina Melunsky, Elizabeth Houghton, Jennifer Bradbury, Adela Apetroaia, Mandy Lau, Emma Cosham,
Lucy Foulkes, Michaela Muggeo, Ashton Kissoon, Joanne Priestly, Sara Andergachew, Catherine Broadway,
Ruth Hammond, Richard Bushell, Gemma Denton and Kelsey Heard for assistance with coding parental
behaviours and therapy sessions; and Jackie Barton, Susie Fornby, Ian Gallimore and Brendan Lawrence for
administrative assistance. We are grateful to Meriel Powell for providing clinical supervision. We are also
grateful to Marie Weber and Katie Hobbs for their help formatting the manuscript.

Contribution of authors

Cathy Creswell and Peter J Cooper had overall responsibility for the study.

Cathy Creswell was responsible for the day-to-day operationalisation and of the study and drafting the
final report.

Susan Cruddace and Rachel Gitau were responsible for day-to-day management of the research and
Lucy Willetts was responsible for clinical management.

Stephen Gerry was responsible for the final statistical analysis of the clinical outcomes, under supervision
of Merryn Voysey and Ly-Mee Yu.

Emma McIntosh led on the design of the economic analysis.

The initial statistical analyses were designed by Jill Mollison.

Lynne Murray and Alan Stein were involved in the design, monitoring the trial and interpretation
of results.

Rosamund Shafran was responsible for developing and overseeing the MCBT intervention.

Mara Violato led on the analysis and drafting of the economic results in collaboration with
Emma McIntosh.

Lucy Willetts and Cathy Creswell were responsible for developing the MCI intervention.

Nicola Williams was responsible for monitoring of randomisation and interim data monitoring.

All authors contributed to drafting the final report.

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
83
addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
Park, Southampton SO16 7NS, UK.
 ACKNOWLEDGEMENTS

Ethical approval

The study was approved by the Berkshire Research Ethics Committee (07/H0505/156) and the University
of Reading Research Ethics Committee (07/48).

Publications

Data from initial assessments of subgroups of participants included in this trial were included in the
following papers:

Creswell C, Apetroaia A, Murray L, Cooper P. Cognitive, affective, and behavioural characteristics of

mothers with anxiety disorders in the context of child anxiety disorder. J Abnorm Psychol 2013;122:26.

Clarke K, Cooper P, Creswell C. The Parental Over-protection Scale: associations with child and parental
anxiety. J Affect Disord 2013;151:618–24.

Orchard F, Cooper PJ, Creswell C. Interpretation and expectations among mothers of children with anxiety
disorders: associations with maternal anxiety disorder. Depress Anxiety 2015;32:99–107.

Publication reporting on trial outcomes

Creswell C, Cruddace S, Gerry S, Murray L, Stein A, Willetts L, et al. Treatment of childhood anxiety
disorder in the context of maternal anxiety disorder: A randomised controlled trial. In preparation.

84
NIHR Journals Library www.journalslibrary.nihr.ac.uk
 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

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Appendix 1 Patient and public involvement

Public involvement in the conduct of the research

A member of the public was a full member of the TSC from initiation to completion of the trial. This lay
member was identified by contacting parents of children that had received treatment for anxiety disorders
at the University of Reading/Berkshire Healthcare NHS Foundation Trust/Berkshire Child Anxiety Clinic. The
individual appointed was the only parent to express an interest who was available to commit to ongoing
participation and so no selection process was needed. The lay member’s contributions to the conduct
of the trial included reviewing information sheets for children and parents, providing feedback on the study
protocol and providing guidance on strategies for successful recruitment. This proved invaluable, particularly
in providing advice on how to best inform potential participants about the trial and recruitment strategies.

Lessons learned

We benefited from the commitment of our one lay representative; however, we were unable to secure a
commitment from other potential lay members, and two general practitioners who gave agreement to join
the TSC were ultimately unable to attend meetings. We clearly recognise the value of patient and public
involvement at all stages of the research process so will include more comprehensive costings to cover the
expenses/lost earnings associated with patient and public involvement and will be more explicit in forming
patient and public involvement relationships (e.g. through honorary appointments) in future grants.

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 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

Appendix 2 Mother and child anxiety trial

study protocol

Treatment of Child Anxiety Disorder in the Context of Maternal Anxiety:

A Randomised Controlled Trial

Trial Acronym: MACh (i.e. mother and child anxiety treatment study)

RATIONALE: The outcome from CBT for children with anxiety disorders is highly variable.
A major factor contributing to this is likely to be the presence of maternal anxiety and the
associated disturbances in mother-child interactions and maternal behaviours. Where parental
anxiety has been addressed in treatment research it has been difficult to assess its contribution
to child outcome. Similarly, where therapeutic measures to address parent-child interactions
have been included, it has not been possible to determine the specific role of such measures in
the treatment package employed.

The trial is a three-arm RCT which aims to determine the extent to which treatments of
maternal anxiety and mother-child interactions enhance standard cognitive behaviour therapy
for children (CCBT) who have anxiety disorders in the context of maternal anxiety disorder
(a group who currently show a poor response to treatment). Index children will receive CCBT
with either additional treatment for maternal anxiety or specific measures to address features
of mother-child interactions; and their outcome will be compared to that of children
receiving standard individual CCBT (together with appropriate control conditions)

A. Background
Childhood Anxiety Disorders
Anxiety disorders are the most common form of psychopathology in children. They have a
significant adverse impact on children’s general socio-emotional functioning and commonly
persist into adulthood.

Treatments of childhood anxiety disorders

Following advances in the development of successful cognitive behavioural therapies (CBT)
for adult anxiety disorders (e.g. Clark & Fairburn, 1996), CBT for child anxiety disorders has
now been developed. Although there is still some uncertainty over the optimal form of such
intervention, recent systematic reviews of outcome research indicate that the general CBT
approach produces significant therapeutic benefit in this patient group. However, it is clear
from these reviews, and from the individual treatment trials, that outcome is highly variable,

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Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
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 APPENDIX 2

with a significant proportion of patients retaining their anxiety diagnoses following treatment
(i.e. 16-61%; James, Soler & Wetherall, 2006).
Predictors of Treatment Outcome
There has been little research into the factors that predict response to CBT in anxious
children, although, in addition to severity of child anxiety, two factors are likely to be
especially significant: anxiety in the mother, and features of mother-child interactions.
i. Anxiety in mothers.
It has been known for some time that the rate of anxiety disorder amongst the parents of
anxious children is raised (Last et al, 1987; Last et al, 1991), but the extent of this elevation
has been uncertain and the implications for treatment outcome of child anxiety have not been
fully considered. Recent research of our own has addressed this issue. In a consecutive series
of children referred for treatment of an anxiety disorder, two thirds of the mothers were found
to have a current DSM-IV anxiety disorder (with no elevated rate of current disorder amongst
the fathers), almost three times the base rate (Cooper et al, 2006). Furthermore, follow up of
the children after treatment revealed a significant association between child response and
level of maternal anxiety (Cooper et al, in press).
ii. Mother-child interactions
Specific features of mother-child interactions have been implicated in the maintenance of
child anxiety, in particular, an over-controlling and over-protective maternal style (see Rapee,
1997; Wood et al, 2003) and associated maternal cognitions and expectations about child
competence (Creswell et al, 2006). Notably, strong associations have been found between
level of maternal anxiety and both maternal behaviours (e.g. Whaley et al, 1999; Bogels &
van Melick, 2004) and maternal expectations of child competence (Wheatcroft & Creswell,
2007). It appears that the disturbances in mother-child interactions which serve to maintain
child anxiety are, at least in part, themselves driven by maternal anxiety. These conclusions
are supported by the findings of further research by our group. We have been conducting a
prospective study of 250 infants born to mothers with anxiety disorders and control mothers
to investigate the intergenerational transmission of anxiety disorders. Recent data from both
this study (Murray et al, 2007), and from an associated experimental study (DeRosnay et al,
2006), have shown that a lack of both appropriate modelling and support, both features of
mothers with anxiety disorders, are associated with the development of anxiety in offspring.

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Implications for optimal treatment outcomes

In so far as CBT treatments of child anxiety disorder commonly require the day-to-day
prosecution of treatment regimes to be managed by the mother (e.g. mothers are typically
required to model positive responses to fear provoking stimuli and to prompt and reinforce
their child’s positive responses), the mother’s own anxiety and the associated disturbances in
mother-child interactions are likely to militate against optimal treatment delivery. Although
the CBT treatments developed to date for the treatment of child anxiety do acknowledge the
importance of both parental anxiety and parenting (e.g. Barrett et al, 1996; Mendlowitz et al,
1999; Nauta et al, 2003; Spence et al, 2000), there has been no systematic evaluation of an
intervention in which both maternal anxiety and mother-child interactions are specifically
addressed. There is, therefore, a need for the development and evaluation of a CBT treatment
for child anxiety disorder in which maternal anxiety and associated disturbances in mother-
child interactions are systematically targeted.
Rationale for the trial
The outcome from CBT for children with anxiety disorders is highly variable. Major factors
contributing to this are likely to be the presence of maternal anxiety and associated
disturbances in mother-child interactions and maternal behaviours. Where parental anxiety
has been addressed in treatment research (e.g. Barrett et al, 1996; Mendlowitz et al, 1999;
Nauta et al, 2003; Spence et al, 2000), for several methodological reasons, it has been
difficult to assess its contribution to child outcome. It is notable, however, that in the single
study in which treatment of parental anxiety was systematically varied, child anxiety outcome
was better where therapeutic measures to address parental anxiety symptoms were included
(Cobham et al, 1998). Whilst this is a finding of critical importance, since the treatment did
not significantly alter levels of parental anxiety it remains unclear what aspect of the
treatment effected the clinical improvement in the children. Similarly, where therapeutic
measures to address parent-child interactions have been included (e.g. Wood et al, 2006), it
has not been possible to determine the specific role of such measures in the complex
treatment package employed. A controlled trial in which both factors – treatment of maternal
anxiety and measures to address mother-child interactions - are systematically varied, would
produce data of both clinical utility and scientific importance.
Research Questions
In an RCT for child anxiety occurring in the context of maternal anxiety, the principal
questions are:

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 APPENDIX 2

1. Is the impact of child CBT (CCBT) enhanced by first providing CBT to the mother
for her own anxiety?
2. Is the impact of CCBT enhanced by the addition of therapeutic measures designed to
improve mother-child interactions?

Secondary questions are:

a. Is sustained improvement in child anxiety significantly associated with a reduction in
maternal anxiety?
b. Is sustained improvement in child anxiety significantly associated with improvements
in maternal modelling, encouragement, over-controlling/over-protective behaviour, and
associated cognitions?

B. Summary
The aim of the trial is to establish the relative effectiveness of treatments of (i) maternal
anxiety and (ii) key features of mother-child interactions for children with anxiety disorders
who have a mother with current anxiety disorder. All treatments will be in addition to
individual Cognitive Behaviour Therapy administered to all children.
Patients who consent to join the trial (participants) will be randomised to one of three
conditions: (i) Child Cognitive Behaviour Therapy (CCBT) plus Cognitive Behaviour
Therapy for Maternal Anxiety (MCBT); (ii) CCBT plus treatment targeting the Mother-Child
Interaction (MCI), (iii) CCBT plus control conditions (see below).

Condition CCBT+MCBT CCBT+MCI CCBT

Standard child CCBT CCBT CCBT
treatment (child: 8 sessions) (child: 8 sessions) (child: 8 sessions)
Treatment of MCBT Counselling control Counselling control
maternal anxiety (mother: 8 sessions) (mother: 2 sessions) (mother: 8 sessions)
Treatment of mother- Family Health MCI Family Health
child interactions Control (child and mother: 2 Control
(child and mother: 2 sessions; mother: 8 (child and mother: 2
sessions; mother: 2 sessions) sessions; mother: 2
sessions) sessions)
Total therapist Child: 8 sessions Child: 8 sessions Child: 8 sessions

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contact Mother: 10 sessions Mother: 10 sessions Mother: 10 sessions

Child and mother: 2 Child and mother: 2 Child and mother: 2
sessions sessions sessions
CCBT: Individual CBT for child anxiety; MCBT: Individual CBT for maternal anxiety; MCI:
Mother-child interaction treatment

C. Eligibility
The trial is open to children with a current primary diagnosis of a major anxiety disorder
(Generalised Anxiety Disorder, Social Phobia, Separation Anxiety Disorder, Panic
Disorder/Agoraphobia, Specific Phobia, as long as co-morbid with another anxiety disorder)
whose mother also has a current major anxiety disorder.
1. Inclusion Criteria
Child:
(i) Aged 7 to 12 years;
(ii) Primary diagnosis of DSM-IV generalised anxiety disorder, social phobia, separation
anxiety disorder, panic disorder/agoraphobia or specific phobia (if co-morbid with another
anxiety disorder).
Mother:
(i) Primary carer;
(ii) Current maternal DSM-IV anxiety disorder.
2. Exclusion Criteria
Participants will not be eligible if the following criteria are met.
Child:
(i) Significant physical1 or intellectual impairment (including ASD)2;
(ii) Current prescription of psychotropic medication (or, if psychotropic medication is
prescribed, it should have been at a stable dose for at least one month with agreement to
maintain that dose throughout the study);

1
Where physical disability would impede treatment delivery (e.g. significant speech/ hearing impairment).
2
Significant intellectual impairment will be determined by children being registered within local learning
disability services. Children will be excluded if they have a current diagnosis of an Autistic Spectrum Disorder
(ASD). In case of undiagnosed ASD, a preliminary assessment will be made at the initial assessment (see
Section S).

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 APPENDIX 2

(iii) Previously received six or more sessions of systematically administered Cognitive-

Behaviour Therapy for an anxiety disorder;
Mother:
(i) Significant intellectual impairment3;
(ii) Severe comorbid disorder (e.g. severe major depressive disorder, psychosis,
substance/alcohol dependence);
(ii) Prescription of psychotropic medication (Or, if psychotropic medication is prescribed, it
should have been at a stable dose for at least one month with agreement to maintain that dose
throughout the study);

3
Significant intellectual impairment will be determined by the mother being registered within local learning
disability services.

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D. Trial Procedures
1. Recruitment schedule

1. Suspected anxiety disorder in child

2. Child aged 7- 12 years
3. Absence of significant physical or intellectual
impairment (including ASD) in child

Assessment by trial assessors at local CAMHS

Does child have current anxiety disorder (Generalised Anxiety Disorder,

Social Phobia, Separation Anxiety Disorder, Panic Disorder +/- Agoraphobia), specific
phobia if co-morbid

NO
YES

Does mother have current Refer back to CAMHS

anxiety disorder? with detailed assessment
report

YES NO
Treatment as Usual
Invite to take part in MRC Trial. (Group CBT)
Does the family agree?

YES

Trial protocol

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 APPENDIX 2

2. Treatment Interventions
There will be two stages of treatment intervention in the trial:
(1) Individual Cognitive Behavioural Treatment for maternal anxiety (MCBT), or control
a. Individual CBT for maternal anxiety
This will consist of an eight session (one hour each) intervention for mothers delivered by a
clinical psychologist (or equivalent) over eight-weeks. Sessions will take place in the
participants’ local CAMHS, within their home, or at the University of Reading. The CBT
programme will follow a manualised transdiagnostic treatment for adult anxiety disorders
(Shafran, unpublished manuscript).
b. Control: Supportive Counselling
This will consist of either two or eight sessions (one hour each) of supportive counselling
(see figure 1), delivered by a clinical psychologist (or equivalent) over eight-weeks. Sessions
will take place in the participants’ local CAMHS, within their home, or at the University of
Reading. The supportive counselling programme will follow a manualised treatment
(Borkovec & Costello, 1993).
(2) Individual Cognitive Behavioural Treatment for child anxiety (CCBT) with Mother
Child Interaction treatment (MCI) or control
Individual CBT for child anxiety
All participating children will receive an eight session (one hour each) intervention based on
the Cool Kids programme (Rapee, 2000), delivered by a clinical psychologist (or equivalent)
over eight-weeks. Sessions will take place in the participants’ local CAMHS, within their
home, or at the University of Reading.
a. Mother-Child Interaction Treatment
This intervention consists of 10 sessions: eight with the mother alone and two with the
mother and child together. This is a novel intervention which specifically targets anxiogenic
features of mother-child interactions. Specifically it aims to enhance maternal cognitions
associated with child competence, reduce maternal overcontrol/overprotection, and enhance
maternal warmth and encouragement. This is achieved through a combination of specific
materials from existing family interventions for childhood anxiety (Rapee & Wignall, 2000;
Wood et al, 2006) and video-feedback techniques developed and piloted by the trial
investigators (Stein et al, 2006; Creswell et al, in press). This intervention is provided by a
clinical psychologist (or equivalent) in parallel with the CCBT sessions. Sessions will
generally take place in the participants’ local CAMHS, within their home, or at the University
of Reading. The two mother and child sessions will be conducted within the laboratory at the

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University of Reading, as these involve the mother and child completing structured tasks
which are video-recorded for feedback purposes.
b. Control: Family Lifestyle Management
This will consist of four sessions, two with the mother alone and two with the mother and
child together. These sessions will focus on promoting a healthy lifestyle with a focus on
family diet and exercise, based on existing packages applied within school settings (British
Dietetic Association, 2003). This intervention is provided by a clinical psychologist (or
equivalent) in parallel with the CCBT sessions. Sessions will generally take place in the
participants’ local CAMHS, within their home, or at the University of Reading.

For all treatment conditions, therapists will routinely rate the extent to which participants
adhere to the intervention (e.g. completion of in-session and homework exercises, session
attendance).
How the second stage interventions run in parallel is illustrated in Section R.

E. Randomisation
Following confirmation of eligibility and informed consent, participants will be randomised
to treatment condition. Randomisation will be performed centrally by facsimile contact at the
Centre for Statistics in Medicine, Oxford (CSM). This will be performed/coordinated by the
Trial Statistician. The randomisation programme will include a minimisation algorithm to
ensure balanced allocation of participants across the three treatment groups for the following
potential prognostic factors: child age, child gender, type of child anxiety disorder (GAD,
Social Phobia, SAD, Other) and baseline severity (ADIS Clinician Severity Rating) of child
and mother’s primary anxiety disorder. To reduce the possibility of outcome measure events
occurring after randomisation and before treatment, intervention will start within 2 weeks of
randomisation.

F. Routine Care Outside of the Trial

Participants (mothers and children) will be asked not to engage in other psychological
interventions during the course of the trial. They will also be asked not to initiate
psychotropic medication and if psychotropic medication is prescribed, this should have been
at a stable dose for at least one month with agreement to maintain that dose throughout the
study. Referrers (Local CAMHS) and General Practitioners will be informed of this
requirement.

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 APPENDIX 2

G. Serious and Unexpected Adverse Events

There are no adverse side-effects of the interventions being delivered. Successful treatment of
anxiety may involve some distress, however this will be managed and contained by qualified
clinical psychologists, receiving regular expert supervision. Although substantial clinical
benefits are anticipated from the interventions, some children and mothers can be expected to
not respond to the interventions. Where children continue to meet criteria for a current
anxiety disorder at the six month post treatment assessment, they will be invited to participate
in a group intervention for anxious children or referred back to their local CAMHS team
following clinical review and liaison. If other significant difficulties emerge these will be
discussed with referrer from the local CAMHS team.

H. Assessment of Outcome
1. Primary outcomes
The primary outcome is child anxiety (assessed both categorically [i.e. diagnosis] and
continuously [i.e. symptoms]). Diagnostic status will be assessed by the ADIS for DSM-IV:
C/P administered to both the mother and child. Assessors will be blind to treatment condition.
Assessors’ beliefs about treatment condition will be formally assessed. Child anxiety
symptoms will be assessed using questionnaires (SCAS; Spence, 1998) administered to the
child, the mother and the child’s teacher. These measures will be administered post-
treatment, and at 6 and 12 month follow-up assessments.

2. Secondary outcomes
Maternal anxiety will be assessed categorically using the ADIS (DSM-IV) and continuously
using questionnaires (i.e. DASS, Lovibond & Lovibond, 1995; PSWQ, Meyer et al, 1990;
SIAS and SPS, Mattick & Clark, 1998). These measures will be administered post-treatment,
and at 6 and 12 month follow-up assessments.
Maternal interactive behaviours will be assessed by filming the mother assisting the child
perform an anxiety provoking task and applying standardised ratings of anxiogenic
behaviours (i.e. modelling, lack of encouragement, overcontrol/overprotection). Interactive
behaviours will be coded by independent, trained, reliable raters. Coders will be blind to the
purpose and conditions of the trial. Maternal cognitions will be assessed by a standardised
interview. These measures will be conducted at the post-treatment assessment.
See Section S for a full assessment schedule.

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3. Health Economic Assessment

An economic evaluation will be undertaken integral to the main trial. The evaluation will
adhere to guidelines for good economic evaluation practice as outlined in the reference case
by Gold et al (1996). The economic analysis will estimate the incremental cost and
effectiveness of each of CCBT/MCBT and CCBT/MCI in relation to the control group as
well as their relative costs. Patient level resource use data, including all health and social care
costs (staff costs for provision of CCBT, MCBT, MCI, and the control interventions, GP
costs, referrals, and other relevant services identified) as well as leisure and productivity
estimates for the parents will be collected within trial forms and valued using appropriate unit
costs. Staff training costs and the costs of staff supervision will also be identified and
allocated pro-rata. The outcome measure for the cost-effectiveness analysis will be the ADIS
as well as a measure of ‘days off school avoided’. In line with recent recommendations from
the National Institute for Health and Clinical Excellence (NICE) the economic evaluation will
also include generic quality of life instruments, the child friendly EuroQol EQ-5D (EuroQol,
1990; Hennesy & Kind, 2002) and HUI2 outcome measure (Feeny et al, 1995), on which
normative data are available. Measures of the impact of anxiety disorders will also be
included, using questionnaires administered to the child and mother (CAIS; Langley et al,
2004) and teacher (School Adjustment/ Teacher Report Form; Achenbach, 1986). These
instruments will be administered at baseline, following treatment and at 6 and 12 months
follow up.

I. Power and Sample Size

A total sample size of 210 pairs of anxious children with anxious mothers will be recruited
into the trial. This sample size is based on calculations relating to the primary outcome of
child anxiety diagnosis for the principal questions.
i. Efficacy of CCBT/MCBT:
Comparison of Group 1 and the Control Group. To detect an absolute difference of 30% in
success (i.e. absence of child anxiety diagnosis) post-treatment for CCBT/MCBT compared
with control (40% to 70%), with 90% power at the 5% significance level (two sided) would
require 56 patients per treatment group. This difference is based on reported effect of CBT
with parental anxiety management in children where at least one parent had high anxiety
(Cobham et al, 1998).
ii. Efficacy of CCBT/MCI:

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
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 APPENDIX 2

Comparison of Group 2 and the Control Group. Assuming that the response to treatment in
the control group is 40% (from Cobham et al, 1998) and the minimum clinical difference in
response due to MCI is 30%, 56 patients per group are required to enable us to detect this
difference with 90% power at the 5% significance level.

Thus, 56 patients are required in each of the three randomised groups. Accounting for a 20%
loss to follow up would require 210 children in total to be recruited to the study. No formal
comparison will be made between Groups 1 and 2 (CCBT/MCBT and CCBT/MCI). The
sample size has been estimated as if two independent trials were conducted, with no
adjustment for multiple testing, as recommended by Machin et al (1997).

A difference of 30% in the proportion of anxiety-free children following completion of the

treatment is considered to be the minimum that would be clinically worthwhile taking into
account the increased resources required and change to service delivery that would be
required if either of these interventions were found to be effective and implemented in
practice.

J. Data Management
Data management will be consistent with MRC Guidelines for Good Clinical Practice in
Clinical Trials (MRC, 1998) and with the Data Protection Act (1998). Principal investigators
will ensure that all personnel are familiar and comply with the MRC guidelines, particularly
section 5.9 ‘Data handling and record keeping’ and section 7 ‘Documentation’.
1. Identifying information
After providing consent, participants will be given a unique, sequential, study identifier. This
will be used for randomisation and data entry purposes.
2. Data entry
Data will be entered in to desktop computers, fitted with SPSS for Windows v13 as standard
allowing for an immediate interactive message to be displayed if an invalid data entry is
made. The Trial Manager will arrange appropriate quality assurance checks.
3. Backing up of data
Immediately after every episode of data entry, data will be backed up onto a portable USB
drive, which will be securely stored locally. These files will be backed up on to a password-
protected system on a weekly basis. A hard copy will be printed and stored locally compliant
with Data Protection Act (1998).

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K. Data Analysis
The principal comparisons will be performed on an intention-to-treat basis. The results from
the trial will be presented as comparative summary statistics (difference in proportion of
anxiety-free children or mean anxiety level) with 95% confidence intervals. The analysis and
reporting of results will follow the general principles of Consolidated Standards of Reporting
Trials (CONSORT; Moher et al, 2001).

The primary analysis will focus on the effect of the intervention following completion of
treatment (post-treatment/16 week assessment). Analysis of the 6 and 12 month outcome
data will utilize all outcome assessments (post treatment, 6 and 12 months) using multilevel
repeated measures analysis, to establish maintenance of change.

Child anxiety diagnosis (ADIS for DSM-IV C/P): The proportion of anxiety-free children in
the two groups following treatment will be compared using the Chi squared test. Testing for a
treatment effect after adjustment for minimisation factors will be conducted using multiple
logistic regression.

Child anxiety symptoms: Change in anxiety scores following treatment will be analysed using
multiple linear regression with baseline score and minimisation factors entered as covariates.
We will formally assess the distribution of the change in anxiety scores for evidence of
departure from normality. If necessary, data will either be transformed or analysed using a
non-parametric equivalent. Change in anxiety scores at 6 and 12 months will be analysed
using a multilevel repeated measures analysis, adjusted for baseline anxiety score and
minimisation covariates.

The secondary research questions will be explored using univariate tests (e.g. Chi squared
test, t-test and correlation) to examine whether the particular factors identified are associated
with sustained improvement in child anxiety. Multiple logistic and linear regression will be
adopted to investigate the independent factors predictive of sustained improvement in child
anxiety.
A comprehensive statistical analysis plan will be produced prior to any data being seen.

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
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 APPENDIX 2

L. Management Structure
1. Trial Management
The Trial Management Group (TMG) comprises the five grant holders, the clinical director
(LW) and the Trial Manager (RG). The group will meet periodically throughout the trial as
requested by the Principal applicant (PJC).
The day to day administration of the trial will be the overall responsibility of the principal
applicant (PJC) who will monitor all aspects of recruitment, treatment and assessment, as
well as the budget.
The child anxiety clinics will be under the direction of the Clinical Director (LW). She will
coordinate all clinical referrals, and, together with her assistant, carry out initial clinical
assessments of all referred children. Where both child and mother are found to have a current
anxiety disorder, the trial manager (RG) will recruit to the trial and, in liaison with the trial
statistician (NA), will ensure randomisation to treatment condition and assign to the
appropriate therapists. The Trial Manager will also coordinate and supervise the maternal and
child assessments. Assessment and coding of the mother-child interactions will be the under
the supervision of Professor Lynne Murray.
Professor Roz Shafran (Reading) will train and supervise the adult therapists providing
treatment to mothers. The therapists providing the non-directive counseling (control
condition) will be supervised by an experienced counseling practitioner and supervisor to
ensure adherence to protocol. The Clinical Director (LW) will supervise the two child
therapists delivering CCBT to the children and the mother-child interaction treatment as well
as the healthy lifestyle sessions (control). Professor Alan Stein will provide supervision to Dr
Willetts on the interaction treatment.
The Trial Manager (RG) will have responsibility for the data file which will be handed over
to the Trial statistician for analysis. The Trial Manager will also liaise with Dr McIntosh to
ensure that all health economic data are collected appropriately.
2. Trial Steering Committee (TSC)
Overall responsibility for the trial will lie with the Trial Steering Committee comprising:
Professor Jonathon Hill (Chair), Dr Gavin Malloch (MRC), Dr Natasha Conner and Vicky
Taylor (Berkshire Healthcare NHS Foundation Trust), Dr Pasco Fearon (Reading) and a
consumer representative. Their function is to maintain the overall integrity of the trial, to
receive and consider reports from both the Trial Management Group and IDMEC and take
action if appropriate. The Trial Steering Committee will meet before the trial is initiated and
then every 6 months throughout the trial.

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3. Independent Data Monitoring and Ethics Committee (IDMEC)

The Independent Data Monitoring and Ethics Committee will be chaired by Professor
Jonathon Geddes (Oxford). Other members are Dr Craig Ramsay (Aberdeen) and a
representative from Berkshire Healthcare NHS Foundation Trust). The Trial statistician will
also attend meetings to present reports. The IDMEC will monitor: recruitment to the trial,
protocol adherence and serious adverse events as well as the difference between trial
treatments on the primary outcome measures. The IDMEC will consider reports prepared by
the Trial Statistician and any other relevant studies published during the timeframe of the
trial. Recommendations of IDMEC will be passed on to the Chair of the Steering Committee.
The Data Monitoring and Ethics Committee will meet throughout the trial as determined by
the Chair.

M. Indemnity
University of Reading indemnity will apply:
i. To meet the potential legal liability of the University of Reading for harm to participants
arising from the management and design of the research.
ii. To meet the potential legal liability of the investigators/collaborators arising from harm to
participants in the conduct of the research.
iii. For payment of compensation in the event of harm to the research participants where no
legal liability arises.

N. Ethics
Berkshire Local Research Ethics Committee has given a favourable opinion of this study
(07/H0505/156), as has the University of Reading Research Ethics Committee (07/48). All
aspects of the study will be conducted in line with MRC Guidelines for Good Clinical
Practice in Clinical Trials (MRC, 1998).

O. Informed Consent
Information about the trial will be provided to both the mother and child in person from the
Clinical Director (LW) as well as in written information. A copy will be provided for the
participants to keep. Written consent will be obtained from parents by the Clinical Director
(LW). Assent will be obtained from children. Following treatment completion, participants
will be asked whether they would be happy for video-taped material to be used for teaching
and training purposes. Where participants agree, separate written consent will be obtained.

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
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addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
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 APPENDIX 2

P. Publications and Ancillary Studies

1. Publications
A meeting of the Trial Management Group will be held on completion of the study to allow
discussion of the main results among the collaborators. The results will then be presented to a
combined meeting of the TSC and IDMEC for comment. Public presentations pertaining to
the main trial must not be made without the prior agreement of the Trial Management Group.
2. Ancillary studies
Ancillary studies will be conducted by Dr Cathy Creswell (MRC Clinician Scientist
Fellowship, Reading), Mr Ray Percy (PhD student, Reading) and Dr Thalia Eley (Institute of
Psychiatry, London), in collaboration with Peter Cooper. The protocols for these studies will
be referred to the Trial Steering Committee, whose responsibility is to safeguard the integrity
of the trial, for final approval. Any further proposals for ancillary studies should initially be
referred to the Trial Management group for consideration. Studies considered appropriate by
the TMG will then be submitted to the TSC for final approval. In principle it is preferable for
the trial to be kept as simple as possible with few further add-on studies.

Q. Proposed Timetable
Main tasks Proposed timetable
Finalise protocols May- November 2007

Submit Ethics & Trust approval August 2007

Register Trial 1 September 2007

Receipt of MRC award
In post:
Cathy Creswell (Trial Manager; MRC)
Lucy Willetts (Clinic Manager;
NHS/MRC)

Ethics Outcomes November 2007

Invite referrals from East and West Berks September- December 2007
(establish wait-list for assessments)

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Recruit remaining University & Trust

staff
Establish satellite clinics
Convene Trial Steering Committee and
IDMEC

Training University and Trust staff January – February 2008

Initiation of assessments January 2008

Initiation of treatment March 2008

Recruitment ends 30 August 2010

Treatments end 31 January 2011

Trials end 30 June 2012

Recruitment assessments will be conducted from January 2008 until end of August 2010 (32
month), therefore we aim to recruit 6-7 new cases to the trial every month.

R. Stage 2 Treatment (CCBT/MCI/FH) Outline

Week CCBT MCI FH
(child 8 sessions) (mother 8; mother& (mother 2; mother
child 2) & child 2)

1 Session 1 Introduction- 1. Mother Mother

Getting to know each 1. Introduction- 1. Introduction-
other psycho-education and healthy family
2. Psychoeducation rationale. lifestyle

2 Session 2 1. Update & review Mother

2. How I feel depends 1. Update & Review

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
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 APPENDIX 2

on what I think; 2. Promoting

Detective Thinking autonomy (i):Self-
help skills: giving
choices, allowing
struggle, attention
(ii) Feedback on video
from research
assessment: highlight
parental positive
impact on child
through autonomy
granting,
encouragement,
modelling, cognitions
re child coping)
3 Session 3 1. Update & review Mother
2. How I feel depends 1. Update & Review
on what I think; 2. Promoting
Detective Thinking autonomy
Practice (i) Alternative
strategies: managing
child’s anxious
thoughts

4 Session 1. Update & review Mother Mother & Child

4A 2. Rewards 1. Update & review Family diet
2. Promoting
autonomy:
encouraging brave
behaviour; inc CALM
strategy (reflective
listening, selective
attention , planned

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ignoring), positive
encouragement
(verbal and
nonverbal), modelling
brave behaviours

4 Session Mother & Child

4B Video Task: setting
up an exposure
hierarchy
5 Session 5 1.Update &review Mother
2. Problem solving 1. Update & Review
2. Video feedback (to
highlight successful
autonomy granting).
3. Promoting
autonomy: Family
problem-solving
6 Session 1. Update & review Mother Mother & Child
6A 2. Practice 1. Update and review Family exercise
2. Promoting
autonomy: New roles
6 Session Mother & Child
6B Challenging task
7 Session 7 1. Update & review Mother
2. Practice 1. Update & Review
2. Video feedback (to
highlight successful
autonomy granting,
modelling,
encouragement
(verbal/nonverbal),
positive cognitions re

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
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Park, Southampton SO16 7NS, UK.
 APPENDIX 2

child coping).
8 Session 8 1. Update & review Mother Mother
2. You did it 1. Update & Review Healthy family
2. You did it- what lifestyle
helped? Future plans/ Review and
Relapse Prevention summary

S. Assessment Schedule

l clinical assessment Structured clinical interviews:

Conducted within local CAMH 1. Anxiety Disorders Interview Schedule-

service Child/Parent version (ADIS-C/P)
2. Anxiety Disorders Interview Schedule (ADIS)
(Mother self-report)

Questionnaires:

1. Spence Children’s Anxiety Scale –parent/child

version (SCAS-c/p)
2. Child Anxiety Impact Scale- parent/child version
(CAIS-c/p)
3. Depression Anxiety Stress Scales (DASS)
4. Penn State Worry Inventory
5. Mattick Social Phobia Scale and Social Interaction
Assessment Scale (SPS, SIAS)
6. Over-involvement questionnaire (POI) parent self-
report
7. Social Communication Questionnaire (SCQ)
8.The Short Moods and Feelings Questionnaire-
Child/Parent version (SMFQ-C/P)
9.The Strengths and Difficulties Questionnaire -
Child/Parent version (SDQ-C/P)

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Research assessment 1. (pre- 1. Laboratory assessment of mother-child interaction

treatment) and associated cognitions

Conducted at University of Reading 2. Spence Children’s Anxiety Scale-teacher report

(SCAS-T)
3. Teacher Report Form (TRF)
4. Teacher report- child adjustment to school
5. Health economic assessments (EQ-5D, HUI-2,
diaries)
Research assessment 1b. (mid-
treatment) Structured clinical interviews:

Conducted at University of Reading/ 1. Anxiety disorders Interview Schedule-

Local CAMH service Child/Parent version (ADIS-C/P)
2. Anxiety Disorders Interview Schedule (ADIS)
(Mother self-report)

Questionnaires:

1. Spence Children’s Anxiety Scale –parent/child

version (SCAS-c/p)
2. Child Anxiety Impact Scale- parent/child version
(CAIS-c/p)
3. Depression Anxiety Stress Scales (DASS)
4. Penn State Worry Inventory
5. Mattick (SPS, SIAS)
6. Over-involvement questionnaire (POI) parent self-
report
7. The Short Moods and Feelings Questionnaire-
Child/Parent version (SMFQ-C/P)
8. The Strengths and Difficulties Questionnaire -
Child/Parent version (SDQ-C/P)

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
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 APPENDIX 2

9. Therapy Questionnaire
10. Health economic assessments (EQ-5D, HUI-2,
diaries)

Research assessment 2 (post- Structured clinical interviews:

treatment)
1. Anxiety Disorders Interview Schedule-
Conducted at University of Reading Child/Parent version (ADIS-C/P)
2. Anxiety Disorders Interview Schedule (ADIS)
(Mother self-report)

Questionnaires:

1. Spence Children’s Anxiety Scale –parent/child

version (SCAS-c/p)
2. Child Anxiety Impact Scale- parent/child version
(CAIS-c/p)
3. Depression Anxiety Stress Scales (DASS)
4. Penn State Worry Inventory
5. Mattick (SPS, SIAS)
6. Over-involvement questionnaire (POI) parent self-
report
7. The Short Moods and Feelings Questionnaire-
Child/Parent version (SMFQ-C/P)
8. The Strengths and Difficulties Questionnaire -
Child/Parent version (SDQ-C/P)

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9. Health economic assessments (EQ-5D, HUI-2,

diaries)

Other

1. Laboratory assessment of mother-child interaction

and associated cognitions

Research assessment 3 (6 months Structured clinical interviews:

post-treatment)
1. Anxiety Disorders Interview Schedule-
Conducted at University Of Reading/ Child/Parent version (ADIS-C/P)
Local CAMH service
Questionnaires:

1. Spence Children’s Anxiety Scale –parent/child

version (SCAS-c/p)
2. Child Anxiety Impact Scale- parent/child version
(CAIS-c/p)
3. Depression Anxiety Stress Scales (DASS)
4. Penn State Worry Inventory
5. Mattick (SPS, SIAS)
6. Over-involvement questionnaire (POI) parent self-
report
7. The Short Moods and Feelings Questionnaire-
Child/Parent version (SMFQ-C/P)
8. The Strengths and Difficulties Questionnaire -
Child/Parent version (SDQ-C/P)
9. Spence Children’s Anxiety Scale-teacher report
(SCAS-T)
10. Teacher Report Form (TRF)
11. Teacher report- child adjustment to school

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
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addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
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 APPENDIX 2

12. Health economic assessments (EQ-5D, HUI-2,

diaries)

Research assessment 4 (12 months Structured clinical interviews:

post-treatment)
1. Anxiety disorders Interview Schedule-
Conducted at University Of Reading/ Child/Parent version (ADIS-C/P)
Local CAMH service
Questionnaires:

1. Spence Children’s Anxiety Scale –parent/child

version (SCAS-c/p)
2. Child Anxiety Impact Scale- parent/child version
(CAIS-c/p)
3. Depression Anxiety Stress Scales (DASS)
4. Penn State Worry Inventory
5. Mattick (SPS, SIAS)
6. Over-involvement questionnaire (POI) parent self-
report
7. The Short Moods and Feelings Questionnaire-
Child/Parent version (SMFQ-C/P)
8. The Strengths and Difficulties Questionnaire -
Child/Parent version (SDQ-C/P)
9. Spence Children’s Anxiety Scale-teacher report
(SCAS-T)
10. Teacher Report Form (TRF)
11. Teacher report- child adjustment to school
12. Health economic assessments (EQ-5D, HUI-2,
diaries)

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Appendix 3 Health economic measures

Health economic logs

MaCh ECONOMIC LOG

Log for recording resources used, and duration of,

any clinical contact

Important: Please complete a new log every time a

contact is made (client visit, phone contact, school
visit e.t.c.)

Patient ID:

Date:

Type of contact Session No. Duration of contact

Maternal CBT

Maternal Counselling

Child CBT

MCI

Healthy Living

Supervision time
(time spent
discussing this
particular patient)

Preparation time &

record keeping

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
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 APPENDIX 3

Other* (please state)

* Please record all phone contact, school visits, home visits and
any other types of visit.

Additional Resources used (Staff only)

Please record below any travel mileage, rail fares or other

expenses incurred during this contact

_______________________________________________
____

_______________________________________________
____

_______________________________________________
____

_______________________________________________
_

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 Health economics diary/patient-held resource use diary

Participant number:
Assessment:
Date:
Diary 1

Park, Southampton SO16 7NS, UK.

DOI: 10.3310/hta19380

One component of this study is to provide the NHS with information about the costs of different treatments and the overall
impact this has on the use of other health and social services, as well as medications, time off work and time off school for
children. In order to do this we would like you to use this diary to record you and your child‛s use of such services, and
treatments that you and your child have had.
This is a 'Diary' (or record) of your use of services, medications and time off work and school between now and your next assessment
appointment, for any cause. It is for your use only, to fill in each time you come into contact with any of the health professionals or
use any of the facilities listed over the page. We would also like you to keep a record of any prescription drugs and medications taken
as well as days off work and school.
For example: If you or your child visits the GP surgery we would like you to tick one of the circles on the line 'Family Doctor (GP)'.
One tick = one visit. If you are prescribed a drug then we would like to know the name of it and whether it is for you or your child.
This Diary covers the period from Study Entry to your next trial assessment. At your next assessment we will ask you about your
‘resource use‛ during this time period. Please remember to bring your diary along to this appointment so that you may use it to
complete this questionnaire.
We will give you new diaries every time a ‘resource use‛ questionnaire has been completed so that you can use the diary to keep a record
of your use of services ready to complete the next questionnaire.
N.B: Please do not include any appointments related to the study itself such as the therapy sessions.

Berkshire Child Anxiety Clinic

University of Reading
Berkshire Research Ethics reference number: 07/H0505/156-157-176
University of Reading Ethics reference number: 07/48-49-50
Version 1.4 (31.07.08)

provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for

addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

121
 122
Starting from when you entered the trial, should you or your child come into contact with any of the people/facilities listed below, please tick one of
the circles.
APPENDIX 3

YOU: If the contact/visit was for yourself, YOUR CHILD: If the contact/visit was for your child,
tick one of the circles in this section: tick one of the circles in this section:
Family Doctor (GP)
Social Worker
Practice nurse
Psychologist
Psychiatrist
Community Psychiatric Nurse

NIHR Journals Library www.journalslibrary.nihr.ac.uk

Education Welfare Officer
Educational Psychologist
Family Liaison Officer (School)
Teacher (other than usual contact)
Paediatrician (children’s doctor)
Audiology
Speech and language
Opthalmology
Hospital A&E department
Occupational Therapist
Paediatric Dietician
Paediatric Physiotherapist
Paediatric Play Specialist
Family Therapist
Community Children’s Nurse
Child & Adolescent Mental Health Nurse
Primary Mental Health Worker
Housing Department
Citizens Advice Bureau
Family centre
Home-start
Alcohol or drug counselling
Other (please specify) * _ _ _ _ _ _ _ _ _ _
Other (please specify) *_ _ _ _ _ _ _ _ _ _
 * If you can only remember the name of the person you saw then please write the name down.
Drug Treatments
In this following section we would like to know whether you or your child have been prescribed, or purchased, any drugs or medications.
Please keep a record below of any drugs/medications and whether it was prescribed by your GP or purchased yourself:

Park, Southampton SO16 7NS, UK.

DOI: 10.3310/hta19380

Drug name Prescription Duration of Treatment For yourself or your child (circle)
___________ Yes/No __________________ Yourself/child
___________ Yes/No __________________ Yourself/child
___________ Yes/No __________________ Yourself/child
___________ Yes/No __________________ Yourself/child

Time off work and School

Finally, we are interested in whether you have taken any time off work or your usual activities and whether you child has had to have
days off school due to ill health.
If you are in paid employment please keep a record of the days off work you take due to you or your child‛s ill health:
Please tick one circle for every day you take off due to ill health:
If you are not in paid employment please keep a record of the days, if any, of your usual activities you have had to give up due to you or
your child‛s ill health:
Please tick one circle for every day you take off your usual activities (e.g. child care, hobbies, shopping):

Your Child: Time off School

Please keep a record of the number of whole days your child has off school Number of half days off school

Travel Costs
Finally, if you have incurred any travel expenses since your last assessment as a result of the treatment we have provided please enter
the approximate amount:
Nb: Please don‛t divulge the number of treatment sessions you have received to your research assistants!

provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for

addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

123
 APPENDIX 3

Your use of Health and Social Services in the last 8 weeks

SERVICES THAT YOU AND YOUR CHILD HAVE USED IN THE LAST 8 WEEKS

Have you or your child had any visits or visited any of the following
services since you joined the study? If so, please write the number of
visits for yourself or your child in the appropriate box. If you cannot
remember the exact number of visits, don‛t worry, please just give your
best guess. Please ignore any services that you have not used. If you
have used the diary about your use of services we sent you at the
beginning of the study then please use that to fill in the answers below.
Please do not include any appointments related to the trial itself such as
the CBT therapy sessions. Thank you.

Visits to/from Yourself Your Child

Example GP 1 3
Family Doctor (GP)

Social Worker

Practice nurse

Psychologist

Psychiatrist

Community Psychiatric Nurse

Education Welfare Officer

Educational Psychologist

Family Liaison Officer (School)

Teacher (other than usual contact)

Paediatrician (children’s doctor)

Obstetrician (woman’s doctor)

Audiology

Speech and language

Opthalmology

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 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

Hospital A & E Department

Occupational Therapist

Paediatric Dietician

Paediatric Physiotherapist

Paediatric Play Specialist

Family Therapist

Community Children’s Nurse

Child & Adolescent Mental Health Nurse

Housing Department

Citizens Advice Bureau

Family Centre

Home-start

Alcohol or drug counselling

Other (Please specify)

Drug treatments
In this following section we would like to know whether you or your child
have been prescribed, or purchased, any drugs or medications in the last
8 weeks.

Please note the name of the drug/medication and whether it was

prescribed by your GP or purchased yourself:

Drug name Prescription Duration of treatment For yours

___________ Yes/No _______________ Yourself/child
___________ Yes/No _______________ Yourself/child
___________ Yes/No _______________ Yourself/child
___________ Yes/No _______________ Yourself/child

Time off work and School

Finally, we are interested in whether you have taken any time off work or
your usual activities and whether you child has had to have days off
school due to ill health in the last 8 weeks.
Are you in paid employment? Yes/No (circle)

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
125
addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
Park, Southampton SO16 7NS, UK.
 APPENDIX 3

If yes, have you taken time off work in the last 8 weeks due to ill health?
Yes/No (circle)
If yes, please state how many: Days

If you are not in paid employment please state the number of days, if any,
of your usual activities (e.g. child care, hobbies, shopping) you have had to
give up in the last 8 weeks due to ill health: Days

Time off school

Has your child had to have days off school in the last 8 weeks due to ill
health? Yes/No (circle)
If yes, please state how many: Days

Travel costs
Finally, if you have incurred any travel expenses in the last 8weeks as a result
of your CBT treatment please enter the approximate amount:

Thank you for completing this questionnaire. If you have any queries
or concerns please do not hesitate to contact ***** Tel:

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 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

TABLE 89 Unit costs

Item Unit cost (£) Source Notes

Family doctor (GP 40 Personal Social Services Research Table 10.8b. Cost including
consultation in surgery) Unit. Unit Costs of Health and qualifications, excluding other
Social Care 2012. Kent: direct care staff costs
University of Kent; 2012

Social worker 74 Personal Social Services Research Table 11.3. Cost per hour of
Unit. Unit Costs of Health and face-to-face contact, including
Social Care 2012. Kent: qualifications
University of Kent; 2012

Practice nurse (nurse 13.69 Personal Social Services Research Table 10.6. Cost including
consultation in surgery) Unit. Unit Costs of Health and qualifications, excluding other
Social Care 2012. Kent: direct care staff costs and based
University of Kent; 2012 on duration of contact of
15.5 minutes

Psychologist 136 Personal Social Services Research Table 9.5. Cost per hour of client
Unit. Unit Costs of Health and contact (includes A to E: A = wages/
Social Care 2012. Kent: salary; B = salary oncosts;
University of Kent; 2012 C = qualifications; D = overheads;
E = capital overheads)

Consultant: psychiatrist 383 Personal Social Services Research Table 15.7. Cost per face-to-face
Unit. Unit Costs of Health and contact, including qualifications
Social Care 2012. Kent:
University of Kent; 2012

Community psychiatrist nurse 76 Personal Social Services Research Table 10.2. Cost per hour of
(nurse – mental health) Unit. Unit Costs of Health and face-to-face contact
Social Care 2012. Kent: (including qualifications)
University of Kent; 2012

Education welfare officer 20.44 Local Government Earnings Survey Education welfare officer, median
2011/12 – Observed Pay Rates. annual gross pay (FTE). Unit cost
URL: www.local.gov.uk/web/guest/ calculated using information on
local-government-intelligence/-/ local government pension
journal_content/56/10171/ schemes and employer National
3015313/ARTICLE-TEMPLATE Insurance contributions. Adjusted
(accessed 22 April 2013) for inflation using RPI
Educational psychologist 37.29 Local Government Earnings Survey Educational psychologist, median
2011/12 – Observed Pay Rates. annual gross pay (FTE). Unit cost
URL: www.local.gov.uk/web/guest/ calculated using information on
local-government-intelligence/-/ local government pension
journal_content/56/10171/ schemes and employer National
3015313/ARTICLE-TEMPLATE Insurance contributions. Adjusted
(accessed 22 April 2013) for inflation using RPI

Family liaison officer (school) 49 Personal Social Services Research Table 11.8. Costs per hour of
(approximated with family Unit. Unit Costs of Health and client-related work
support worker) Social Care 2012. Kent:
University of Kent; 2012

Teacher 35.41 Department of Education. Statistical Table 9a. Average salary (£) in
First Release. School Workforce in total, publicly funded school.
England, November 2011. URL: Salary oncosts have been
www.education.gov.uk/rsgateway/ included in the calculation of the
DB/SFR/s001062/sfr06–2012v7.pdf unit cost. Adjusted for inflation
(accessed 16 April 2013) using RPI
continued

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
127
addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
Park, Southampton SO16 7NS, UK.
 APPENDIX 3

TABLE 89 Unit costs (continued )

Item Unit cost (£) Source Notes

Paediatrician: outpatient 225 National Schedule of Reference NHS trusts. Consultant led, first
department – paediatrics Costs Year: ‘2011–2012’. attendance, non-admitted, face
URL: www.gov.uk/government/ to face. Service code: 420
publications/nhs-reference-costs-
financial-year-2011-to-2012
(accessed 18 April 2013)

Audiology: outpatient 110 National Schedule of Reference As above. Weighted average

department – paediatric Costs Year: ‘2011–2012’. of (A), (B) and (C). (A) service
audiological medicine (A), URL: www.gov.uk/government/ code 254; (B) service code 310;
audiological medicine (B), publications/nhs-reference-costs- (C) service code 840
audiology (C) financial-year-2011-to-2012
(accessed 18 April 2013)

Speech and language 33 Personal Social Services Research Table 9.3. Cost
(community speech and Unit. Unit Costs of Health and including qualifications
language therapist) Social Care 2012. Kent:
University of Kent; 2012

Ophthalmology: outpatient 107 Personal Social Services Research As above. Weighted average of
department –ophthalmology Unit. Unit Costs of Health and (A), (B), (C) and (D). (A) service
(A), paediatric ophthalmology Social Care 2012. Kent: code 130; (B) service code 216;
(B), medical ophthalmology University of Kent; 2012 (C) service code: 460; (D) service
(C), orthoptics (D), code 655; (E) service code 662
optometry (E)

Hospital A&E department 108 National Schedule of Reference A&E services: no leading to
Costs Year: ‘2011–2012’. admitted. Weighted average of
URL: www.gov.uk/government/ all services in the category
publications/nhs-reference-costs-
financial-year-2011-to-2012
(accessed 18 April 2013)
Occupational therapist 33 Personal Social Services Research Table 9.2. Cost including
Unit. Unit Costs of Health and qualifications
Social Care 2012. Kent:
University of Kent; 2012

Paediatric dietitian 34 Personal Social Services Research Table 13.4. Cost including
Unit. Unit Costs of Health and qualifications
Social Care 2012. Kent:
University of Kent; 2012

Paediatric physiotherapist 74 National Schedule of Reference Community physiotherapy

Costs Year: ‘2011–2012’. services: child, one-to-one
URL: www.gov.uk/government/ services, service code N5C1
publications/nhs-reference-costs-
financial-year-2011-to-2012
(accessed 18 April 2013)
Paediatric play specialist 11.55 Local Government Earnings Survey Playworker, median annual gross
2011/12 – Observed Pay Rates. pay (FTE). Unit cost calculated
URL: www.local.gov.uk/web/guest/ using information on local
local-government-intelligence/-/ government pension schemes
journal_content/56/10171/ and employer National Insurance
3015313/ARTICLE-TEMPLATE contributions. Adjusted for
(accessed 22 April 2013) inflation using RPI

Family therapist (family 49 Personal Social Services Research Table 11.8. Costs per hour of
support worker) Unit. Unit Costs of Health and client-related work
Social Care 2012. Kent:
University of Kent; 2012

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 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

TABLE 89 Unit costs (continued )

Item Unit cost (£) Source Notes

Community children’s nurse 93 National Schedule of Reference Community nursing services:

Costs Year: ‘2011–2012’. nursing services for children,
URL: www.gov.uk/government/ service code CN101
publications/nhs-reference-costs-
financial-year-2011-to-2012
(accessed 18 April 2013)

Child and adolescent mental 68 Personal Social Services Research Table 12.6. Generic
health worker Unit. Unit Costs of Health and single-disciplinary CAMHS
Social Care 2012. Kent:
University of Kent; 2012

Primary mental health worker 68 Personal Social Services Research Table 12.6. Generic
Unit. Unit Costs of Health and single-disciplinary CAMHS
Social Care 2012. Kent:
University of Kent; 2012

Housing department 19.81 Local Government Earnings Survey Housing officer, median annual
2011/12 – Observed Pay Rates. gross pay (FTE) England. Unit cost
URL: www.local.gov.uk/web/guest/ calculated using information on
local-government-intelligence/-/ local government pension
journal_content/56/10171/ schemes and employer National
3015313/ARTICLE-TEMPLATE Insurance contributions. Adjusted
(accessed 22 April 2013) for inflation using RPI

Citizens advice bureau 15.50 Office for National Statistics (UK). Table 5_SIC07. Full-time
Labour Market, Earnings by employees’ pay by industry sector
Industry. Patterns of Pay: Results (SIC 2007), United Kingdom,
from the Annual Survey of Hours April 2008–12. Industry sector:
and Earnings, 1997–2012. other service activities. Unit cost
URL: www.ons.gov.uk/ons/ calculated using information on
taxonomy/search/index.html? stakeholders pension schemes
nscl=Earnings+by+Industry&nscl- and employer National
orig=Earnings+by+Industry& Insurance contributions
content-type=Dataset&content-
type=Reference+table&
sortDirection=DESCENDING&
sortBy=pubdate (accessed on
19 April 2013)
Family centre (family 49 Personal Social Services Research Table 11.8. Costs per hour of
support worker Unit. Unit Costs of Health and client-related work
Social Care 2012. Kent:
University of Kent; 2012

Home-Start 95.59 McIntosh E, Barlow J, Davis H, Table 1, p. 427. Price inflated to

Stewart-Brown. Economic 2011/12 prices using the
evaluation of an intensive HCHS index
home visiting programme: a
cost-effectiveness analysis from a
societal perspective. J Publ Health
2009;3:423–33
Other health and social care 81.12 Authors’ calculations Average of all other unit costs
resource use

Therapist: newly qualified 39.15 (per Health & Social Care Information Table 3. Basic pay and earnings
clinical psychologist hour); 87.98 Centre. NHS Staff Earnings, for Agenda for Change Band 7
(per hour of Estimates – April–June 2012. (spine point 26), and calculated
client contact) URL: www.hscic.gov.uk/catalogue/ according to the methodology
PUB07388 (accessed adopted in Personal Social
23 April 2013) Services Research Unit. Unit Costs
of Health and Social Care 2012.
Kent: University of Kent; 2012.
Table 9.5
continued

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
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addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
Park, Southampton SO16 7NS, UK.
 APPENDIX 3

TABLE 89 Unit costs (continued )

Item Unit cost (£) Source Notes

Supervisor £70.77 (per Health & Social Care Information Table 3. Basic pay and earnings
hour) £159.03 Centre. NHS Staff Earnings, for Agenda for Change Band 8b
(per hour of Estimates – April–June 2012. (spine point 41), and calculated
client contact) URL: www.hscic.gov.uk/catalogue/ according to the methodology
PUB07388 (accessed adopted in Personal Social
23 April 2013) Services Research Unit. Unit Costs
of Health and Social Care 2012.
Kent: University of Kent; 2012.
Table 9.5

Mileage allowance £0.54 per mile NHS Employers. NHS Terms and Car (all types of fuel), annual
conditions of service handbook. mileage up to 3500 miles
Amendment number 25 – Pay (standard rate)
Circular (AforC) 1/2012. URL: www.
nhsemployers.org/∼/media/
Employers/Documents/Pay%20and
%20reward/AfC_tc_of_service_
handbook_fb.pdf (accessed
12 November 2013)
CAMHS, Child and Adolescent Mental Health Services; FTE, full-time equivalent; GP, general practitioner; SIC, standard
industrial classification.
All costs in 2011/12 prices. For 2010/11 prices adjusted for inflation using RPI 2012 or HCHS 2011/12 as appropriate.

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 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

Health economic supplementary material section 1

Conditional models for multiple imputation using chained equations

Variable imputed: each category of supervision time.

Covariates in the model:

l treatment allocation
l minimisation factors, that is child age, child gender, type of child anxiety disorder (GAD, social phobia,
SAD, other)
l baseline severity (ADIS-IV CSR) of the child’s primary anxiety disorder
l baseline severity (ADIS-IV mother self-report) of the mother’s primary anxiety disorder
l mothers’ baseline depression (DASS-21 – depression)
l child baseline depression symptoms (SMFQ-c, child-reported)
l child behavioural problems (SDQ conduct, mother-reported)
l baseline presence of child social phobia
l all other categories of supervision time.

Variable imputed: total rewards.

Covariates in the model:

l treatment allocation
l minimisation factors, that is child age, child gender, type of child anxiety disorder (GAD, social phobia,
SAD, other).

Variable imputed: baseline EQ-5D for child and mother.

Covariates in the model:

l treatment allocation
l minimisation factors, that is child age, child gender, type of child anxiety disorder (GAD, social phobia,
SAD, other)
l baseline severity (ADIS-IV CSR) of the child’s primary anxiety disorder
l baseline severity (ADIS-IV mother self-report) of the mother’s primary anxiety disorder
l mothers’ baseline depression (DASS-21 – depression)
l child baseline depression symptoms (SMFQ-c, child-reported)
l child behavioural problems (SDQ conduct, mother-reported)
l baseline presence of child social phobia.

Variable imputed: follow-up measurements of child and mother EQ-5D.

Covariates in the model:

l treatment allocation
l minimisation factors, that is child age, child gender, type of child anxiety disorder (GAD, social phobia,
SAD, other)
l measurement of outcomes at previous time points.

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
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addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
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 APPENDIX 3

TABLE 90 Health economic data completeness

Item CCBT + MCBT, %a CCBT + MCI, %b CCBT, %c

CCBT time 34.8 25.4 38

MCBT time 23.2 NA NA

MCI time NA 33.8 NA

NDC time NA 2.8 8.5

FH time 27.5 NA 11.3

Supervision time for CCBT 42.03 47.89 33.80

Supervision time for CCBT 13.04 NA NA

Supervision time for MCI NA 42.25 NA

Supervision time for NDC time NA 73.24 59.15

Supervision time for FH 79.71 NA 74.65

Total cost rewards 75.36 70.42 81.69

Child: EQ-5D score – baseline 1.45 2.82 5.63

Child: EQ-5D score – assessment 1B 13.04 8.45 21.13

Child: EQ-5D score – assessment 2 33.33 21.13 32.39

Child: EQ-5D score – 6-month follow-up 36.23 39.44 40.85

Child: EQ-5D score – 12-month follow-up 50.72 46.48 53.52

Mother: EQ-5D score – baseline 8.70 9.86 15.49

Mother: EQ-5D score – assessment 1B 33.33 28.17 38.03

Mother: EQ-5D score – assessment 2 37.68 40.85 43.66

Mother: EQ-5D score – 6-month follow-up 37.68 40.85 43.66

Mother: EQ-5D score – 12-month follow-up 50.72 46.48 52.11
NA, not applicable.
a Percentage calculated with respect to the 69 patients in trial arm 1.
b Percentage calculated with respect to the 71 patients in trial arm 2.
c Percentage calculated with respect to the 71 patients in trial arm 3.

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 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

TABLE 91 Response rates of patient-held resource use diaries

Section CCBT + MCBT, %a CCBT + MCI, %b CCBT, %c

Other health and social care resources: child and mother – period 50.7 66.2 45.1
‘baseline to assessment 1B’
Medication use: child and mother – period ‘baseline to 39.1 39.4 32.4
assessment 1B’
Other health and social care resources: child and mother – period 24.6 35.2 28.2
‘assessment 1B to assessment 2’
Medication use: child and mother – period ‘assessment 1B to 18.8 32.4 26.8
assessment 2’
Other health and social care resources: child and mother – period 46.4 43.6 42.3
‘assessment 2- to 6-month follow-up’
Medication use: child and mother – period ‘assessment 2- to 46.4 43.6 42.3
6-month follow-up’
Other health and social care resources: child and mother – period 28.9 26.8 29.6
‘6–12 months follow-up’
Medication use: child and mother – period ‘6–12 months follow-up’ 33.3 32.4 42.3
a Percentage calculated with respect to the 69 patients in trial arm 1.
b Percentage calculated with respect to the 71 patients in trial arm 2.
c Percentage calculated with respect to the 71 patients in trial arm 3.

TABLE 92 Other health and social care resources: child – period between assessment 1A (baseline) and assessment
1B (mid-treatment)

Mean (SD)

Resource use (contacts): child CCBT + MCBT CCBT + MCI CCBT

Family doctor 1.11 (1.59) 0.36 (0.76) 0.5 (0.80)
Social worker 0.13 (0.88) 0.25 (1.41)
Practice nurse 0.03 (0.17) 0.09 (0.28) 0.06 (0.25)
Psychologist 0.09 (0.50) 0.13 (0.74) 0.06 (0.25)
Education welfare officer 0.021 (0.15) 0.13 (0.71)
Educational psychologist 0.06 (0.34) 0.04 (0.21)
Family liaison officer 0.11 (0.68) 0.04 (0.29)
Teacher 0.34 (1.21) 0.62 (3.10) 0.66 (2.50)
Paediatrician 0.2 (0.63) 0.15 (0.47)
Audiology 0.06 (0.34)
Speech and language 0.03a (0.17) 0.02 (0.15) 0.06 (0.25)
Ophthalmology 0.06 (0.24) 0.04 (0.20)
Hospital A&E department 0.11 (0.47) 0.09 (0.28) 0.06 (0.35)
Occupational therapist 0.09 (0.51)
Paediatric physiotherapist 0.06 (0.32)
Community children’s nurse 0.14 (0.85)
Child and adolescent mental health worker 0.02 (0.15)
Primary mental health worker 0.03 (0.18)
b c
Other 0.57 (1.03) 0.79 (1.59) 0.71c (1.36)
Observations 35 47 32
a Only 22 observations.
b Only 29 observations.
c Only 22 observations.

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
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 APPENDIX 3

TABLE 93 Other health and social care resources: mother – period between assessment 1A (baseline) and
assessment 1B (mid-treatment)

Mean (SD)

Resource use (contacts): mother CCBT + MCBT CCBT + MCI CCBT

Family doctor 1.74 (2.19) 1.04 (1.52) 1.41 (3.24)

Social worker 0.13 (0.88) 0.09 (0.53)

Practice nurse 0.23 (0.49) 0.11 (0.31) 0.22 (0.75)

Psychologist 0.16 (0.57)

Psychiatrist 0.04 (0.29) 0.03 (0.18)

Community psychiatrist nurse 0.22 (1.24)

Education welfare officer 0.02 (0.15) 0.03 (0.18)

Family liaison officer 0.22(1.24)

Teacher 0.23 (0.60) 0.15 (0.72) 0.28 (0.81)

Paediatrician 0.06 (0.25)

Ophthalmologist 0.14 (0.60)

Hospital A&E department 0.09 (0.28) 0.11 (0.37) 0.03 (0.18)

Family therapist 0.06 (0.35)

Community children nurse 0.13 (0.88)

Primary mental health worker 0.03 (0.18)

Housing department 0.02 (0.15) 0.03 (0.18)

Citizens Advice Bureau 0.03 (0.17)

Other 0.77a (1.54) 0.14b (0.58) 0.91c (1.85)

Observations 35 47 32
a Only 22 observations.
b Only 29 observations.
c Only 22 observations.

TABLE 94 Consumption of medications: mother and child – period between assessment 1A (baseline) and
assessment 1B (mid-treatment)

Mean (SD)

Resource use: medications CCBT + MCBT CCBT + MCI CCBT

Mother’s consumption of prescription medications 0.70 (1.10) 0.89 (1.20) 0.78 (1.28)

Mother’s consumption of ‘over-the-counter’ medications 0.15 (0.46) 0.18 (0.55) 0

Child’s consumption of prescription medications 0.48 (0.89) 0.46 (0.84) 0.35 (0.49)

Child’s consumption of ‘over-the-counter’ medications 0.11 (0.32) 0.36 (0.62) 0.22 (0.85)

Observations 27 28 23

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 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

TABLE 95 Other health and social care resources: child – period between assessment 1B (mid-treatment) and
assessment 2 (post treatment)

Mean (SD)

Resource use (contacts): child CCBT + MCBT CCBT + MCI CCBT

Family doctor 0.24 (0.44) 0.64 (1.04) 0.3 (0.47)

Social worker 0.76 (3.15) 0.4 (1.8)

Practice nurse 0.12 (0.49) 0.08 (0.28)

Psychologist 0.32 (1.6)

Education welfare officer 0.18 (0.73)

Family liaison officer 0.04 (0.2)

Teacher 0.24 (0.56) 0.24 (0.83) 0.2 (0.70)

Paediatrician 0.06 (0.24) 0.08 (0.4)

Speech and language 0.06 (0.24)

Ophthalmology 0.04 (0.2)

Hospital A&E department 0.06 (0.24) 0.04 (0.2)

Other 0.25a (0.77) 0.29b (0.77)

Observations 17 25 20
a Only 16 observations.
b Only 17 observations.

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
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addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
Park, Southampton SO16 7NS, UK.
 APPENDIX 3

TABLE 96 Other health and social care resources: mother – period between assessment 1B (mid-treatment) and
assessment 2 (post treatment)

Mean (SD)

Resource use (contacts): mother CCBT + MCBT CCBT + MCI CCBT

Family doctor 1.06 (1.71) 0.8 (0.96) 1.9 (4.94)

Social worker 0.25 (0.79)

Practice nurse 0.06 (0.24) 0.12 (0.33) 0.1 (0.45)

Psychologist 0.4 (1.63)

Community psychiatrist nurse 0.04 (0.2) 1.05 (4.70)

Education welfare officer 0.29 (0.85)

Educational psychologist 0.04 (0.2)

Family liaison officer 0.04 (0.2) 1.2 (4.71)

Teacher 0.12 (0.49) 0.08 (0.4) 0.1 (0.31)

Audiology 0.24 (0.66)

Ophthalmology 0.04 (0.2)

Hospital A&E department 0.2 (0.89)

Occupational therapist 0.18 (0.73)

Housing department 0.41 (1.70) 0.08 (0.28)

Citizens Advice Bureau 0.05 (0.22)
a b
Other 1.77 (3.32) 0.38 (1.53) 1.16c (2.36)

Observations 17 25 20
a Only 13 observations.
b Only 21 observations.
c Only 19 observations.

TABLE 97 Consumption of medications: mother and child – period between assessment 1B (mid-treatment) and
assessment 2 (post treatment)

Mean (SD)

Resource use: medications CCBT + MCBT CCBT + MCI CCBT

Mother’s consumption of prescription medications 0.46 (0.78) 0.96 (1.46) 0.63 (1.38)

Mother’s consumption of ‘over-the-counter’ medications 0.31 (0.63) 0.17 (0.39) 0.05 (0.23)

Child’s consumption of prescription medications 0.38 (0.65) 0.30 (0.63) 0.11 (0.32)

Child’s consumption of ‘over-the-counter’ medications 0.31 (0.48) 0.17 (0.39) 0.05 (0.23)
Observations 13 23 19

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 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

TABLE 98 Other health and social care resources: child – period between assessment 2 (post treatment) and
assessment 3 (6-month follow-up)

Mean (SD)

Resource use (contacts): child CCBT + MCBT CCBT + MCI CCBT

Family doctor 0.66 (1.10) 0.45 (0.77) 0.93 (1.80)

Social worker 0.73 (2.90)

Practice nurse 0.13 (0.43) 0.07 (0.37)

Psychologist 0.13 (0.71) 0.17 (0.75)

Psychiatrist 0.03 (0.18)

Education welfare officer 0.19 (0.90)

Educational psychologist 0.07 (0.37)

Family liaison officer 0.03 (0.18) 0.87 (3.88)

Teacher 0.38 (1.13) 0.35 (1.14) 0.6 (2.43)

Paediatrician 0.19 (0.60) 0.13 (0.50) 0.10 (0.55)

Audiology 0.03 (0.18) 0.10 (0.40)

Ophthalmology 0.03 (0.18) 0.1 (0.40)

Hospital A&E department 0.16 (0.37) 0.06 (0.25) 0.07 (0.25)

Paediatric dietitian 0.03 (0.18) 0.27 (1.46)

Paediatric physiotherapist 0.03 (0.18) 0.03 (0.18)

Paediatric play specialist 0.19 (1.06)

Community children’s nurse 0.03 (0.18)

Child and adolescent mental health worker 0.23 (1.10)

a b
Other 0.83 (1.53) 0.36 (0.92) 0.63c (1.63)

Observations 32 31 30
a Only 12 observations.
b Only 11 observations.
c Only 16 observations.

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
137
addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
Park, Southampton SO16 7NS, UK.
 APPENDIX 3

TABLE 99 Other health and social care resources: mother – period between assessment 2 (post treatment) and
assessment 3 (6-month follow-up)

Mean (SD)

Resource use (contacts): mother CCBT + MCBT CCBT + MCI CCBT

Family doctor 1.34 (1.75) 0.81 (1.05) 1.77 (3.94)

Social worker 0.4 (2.19)

Practice nurse 0.16 (0.45) 0.26 (0.58) 0.13 (0.43)

Psychologist 0.17 (0.75)

Psychiatrist 0.06 (0.25) 0.03 (0.18)

Community psychiatrist nurse 0.31 (1.77) 0.2 (1.10)

Education welfare officer 0.25 (0.92) 0.07 (0.7)

Educational psychologist 0.03 (0.18)

Family liaison officer 0.03 (0.17) 0.73 (3.83)

Teacher 0.41 (1.50) 0.16 (0.73) 0.07 (0.37)

Audiology 0.13 (0.50) 0.10 (0.54) 0.13 (0.73)

Ophthalmology 0.06 (0.25)

Hospital A&E department 0.13 (0.42) 0.06 (0.25) 0.07 (0.26)

Occupational therapist 0.17 (0.91)

Paediatric dietitian 0.06 (0.35)

Family therapist 0.03 (0.18)

Community children’s nurse 0.03 (0.18)

Citizens Advice Bureau 0.09 (0.53) 0.1 (0.55)

a b
Other 0.53 (1.67) 0.69 (1.70) 0.93c (2.28)

Observations 32 31 30
a Only 11 observations.
b Only 13 observations.
c Only 15 observations.

TABLE 100 Consumption of medications: mother and child – period between assessment 2 (post treatment) and
assessment 3 (6-month follow-up)

Mean (SD)

Resource use: medications CCBT + MCBT CCBT + MCI CCBT

Mother’s consumption of prescription medications 0.85 (1.23) 0.69 (0.75) 0.95 (1.24)
Mother’s consumption of ‘over-the-counter’ medications 0.15 (0.49) 0.11 (0.32) 0.05 (0.22)

Child’s consumption of prescription medications 0.60 (0.75) 0.53 (0.84) 0.38 (0.81)

Child’s consumption of ‘over-the-counter’ medications 0.11 (0.46) 0.21 (0.42) 0.05 (0.22)

Observations 20 19 21

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 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

TABLE 101 Other health and social care resources: child – period between assessment 3 (6-month follow-up) and
assessment 4 (12-month follow-up)

Mean (SD)

Resource use (contacts): child CCBT + MCBT CCBT + MCI CCBT

Family doctor 0.96 (1.02) 0.35 (0.65) 0.60 (1.00)

Social worker 0.04 (0.21) 0.53 (2.92)

Practice nurse 0.22 (0.85) 0.27 (0.78)

Psychologist 0.04 (0.21) 0.09 (0.42) 0.57 (2.46)

Psychiatrist 0.03 (0.18)

Education welfare officer 0.03 (0.18)

Educational psychologist 0.04 (0.21) 0.04 (0.21)

Family liaison officer 0.13 (0.63) 0.77 (3.84)

Teacher 0.04 (0.21) 0.17 (0.58) 0.13 (0.43)

Paediatrician 0.13 (0.63) 0.35 (0.93) 0.07 (0.37)

Audiology 0.09 (0.42)

Ophthalmology 0.07 (0.37)

Hospital A&E department 0.04 (0.21) 0.04 (0.2085144) 0.03 (0.18)

Paediatric dietitian 0.23 (1.28)

Paediatric physiotherapist 0.04 (0.21)

Child and adolescent mental health worker 0.03 (0.18)

Primary mental health worker 0.03 (0.18)

a b
Other 0.05 (0.23) 0.05 (0.23) 0.30c (0.93)

Observations 23 23 30
a Only 19 observations.
b Only 19 observations.
c Only 23 observations.

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
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addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
Park, Southampton SO16 7NS, UK.
 APPENDIX 3

TABLE 102 Other health and social care resources: mother – period between assessment 3 (6-month follow-up)
and assessment 4 (12-month follow-up)

Mean (SD)

Resource use (contacts): mother CCBT + MCBT CCBT + MCI CCBT

Family doctor 2.39 (3.49) 1.52 (1.98) 1.37 (1.97)

Social worker 0.22 (1.04) 0.33 (1.83)

Practice nurse 0.04 (0.21) 0.35 (1.27) 0.10 (0.31)

Psychologist 0.39 (1.88) 0.17 (0.83)

Psychiatrist 0.04 (0.21)

Education welfare officer 0.03 (0.18)

Educational psychologist 0.04 (0.21) 0.03 (0.18)

Family liaison officer 0.09 (0.29) 0.73 (3.83)

Teacher 0.13 (0.46) 0.74 (2.53) 0.13 (0.43)

Ophthalmology 0.033 (0.18)

Hospital A&E department 0.17 (0.49) 0.09 (0.42) 0.07 (0.37)

Occupational therapist 0.04 (0.21)

Housing department 0.09 (0.42) 0.03 (0.18)

Citizens Advice Bureau 0.04 (0.21) 0.03 (0.18)

Family centre 0.04 (0.21) 0.07 (0.37)

Home-Start 0.04 (0.21)

Other 0.71a (1.23) 0.37b (1.01) 0.43c (1.04)

Observations 23 23 30
a Only 21 observations.
b Only 19 observations.
c Only 23 observations.

TABLE 103 Consumption of medications: mother and child – period between assessment 3 (6-month follow-up)
and assessment 4 (12-month follow-up)

Mean (SD)

Resource use: medications CCBT + MCBT CCBT + MCI CCBT

a a
Mother’s consumption of prescription medications 0.65 (0.93) 0.45 (0.89) 0.54b (1.07)

Mother’s consumption of ‘over-the-counter’ medications 0.14c (0.35) 0.41 (0.96) 0.26d (0.71)

Child’s consumption of prescription medications 0.52 (0.67) 0.18 (0.50) 0.17 (0.38)
Child’s consumption of ‘over-the-counter’ medications 0.22 (0.67) 0.23 (0.53) 0.21 (0.62)

Observations 23 22 29
a Only 20 observations.
b Only 28 observations.
c Only 22 observations.
d Only 27 observations.

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 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

TABLE 104 Cost of other health and social care resources: child – period between assessment 1A (baseline) and
assessment 1B (mid-treatment)

Mean (SD)

Cost: child CCBT + MCBT CCBT + MCI CCBT

Family doctor £44.57 (63.45) £14.46 (30.56) £20.00 (32.12)

Social worker £26.30 (180.29) £51.50 (291.33)

Practice nurse £0.39 (2.31) £1.16 (3.86) £0.86 (3.37)

Psychologist £11.66 (68.96) £17.36 (100.73) £8.50 (33.45)

Education welfare officer £0.43 (2.98) £2.56 (14.45)

Educational psychologist £2.13 (12.61) £1.62 (7.69)

Family liaison officer £5.60 (33.13) £2.09 (14.29)

Teacher £12.14 (42.89) £21.85 (109.90) £23.24 (88.40)

Paediatrician £45.00 (142.30) £33.51 (104.68)

Audiology £6.29 (37.19)

Speech and language £0.97a (5.65) £0.70 (4.81) £2.06 (8.12)

Ophthalmology £6.11 (25.20) £4.55 (21.83)

Hospital A&E department £12.34 (50.87) £9.19 (30.46) £6.75 (38.18)

Occupational therapist £2.83 (16.73)

Paediatric physiotherapist £4.72 (23.93)

Community children’s nurse £13.28 (78.60)

Child and adolescent mental health worker £1.44 (9.92)

Primary mental health worker 2.13 (12.02)

b c
Other £46.35 (83.41) £64.22 (128.77) £57.26d (110.20)

Observations 35 47 32
a Only 34 observations.
b Only 21 observations.
c Only 24 observations.
d Only 17 observations.

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
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addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
Park, Southampton SO16 7NS, UK.
 APPENDIX 3

TABLE 105 Cost of other health and social care resources: mother – period between assessment 1A (baseline) and
assessment 1B (mid-treatment)

Mean (SD)

Cost: mother CCBT + MCBT CCBT + MCI CCBT

Family doctor £69.71 (87.50) £41.70 (60.70) £56.25 (129.66)

Social worker £26.30 (180.28) £19.31 (109.25)

Practice nurse £3.13 (6.71) £1.45 (4.27) £2.99 (10.28)

Psychologist £21.25 (78.08)

Psychiatrist £16.30 (111.73) £11.97 (67.71)

Community psychiatrist nurse £16.63 (94.05)

Education welfare officer £0.43 (2.98) £0.64 (3.61)

Family liaison officer £10.71 (60.63)

Teacher £8.09 (21.19) £5.27 (25.55) £9.96 (28.77)

Paediatrician £14.06 (55.34)

Ophthalmologist £15.20 (64.32)

Hospital A&E department £9.26 (30.68) £11.49 (40.50) £3.38 (19.09)

Family therapist £3.06 (17.32)

Community children nurse £11.87 (81.39)

Primary mental health worker £2.12 (12.02)

Housing department £0.42 (2.89) £0.619 (3.50)

Citizens Advise Bureau £0.44 (2.62)

Other £62.68a (125.00) £11.19b (47.12) £73.75c (150.02)

Observations 35 47 32
a Only 22 observations.
b Only 29 observations.
c Only 22 observations.

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 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

TABLE 106 Cost of other health and social care resources: child – period between assessment 1B (mid-treatment)
and assessment 2 (post treatment)

Mean (SD)

Cost: child CCBT + MCBT CCBT + MCI CCBT

Family doctor £9.41 (17.49) £25.60 (41.44) £12.00 (18.81)

Social worker £157.53 (649.51) £82.40 (368.50)

Practice nurse £1.61 (6.64) £1.10 (3.79)
Psychologist £43.52 (217.6)
Education welfare officer £3.61 (14.87)

Family liaison officer £1.96 (9.8)

Teacher £8.33 (19.91) £8.50 (29.41) £7.08 (24.64)
Paediatrician £13.24 (54.57) £18 (90.00)
Speech and language £1.94 (8.00)
Ophthalmology £4.28 (21.4)

Hospital A&E department £6.35 (26.19) £4.32 (21.6)

Other £20.28a (62.84) £23.86b (62.60)
Observations 17 25 20
a Only 16 observations.
b Only 17 observations.

TABLE 107 Cost of other health and social care resources: mother – period between assessment 1B (mid-treatment)
and assessment 2 (post treatment)

Mean (SD)

Cost: mother CCBT + MCBT CCBT + MCI CCBT

Family doctor £42.35 (68.51) £32.00 (38.30) £76.00 (197.63)

Social worker £51.50 (161.99)

Practice nurse £0.81 (3.32) £1.64 (4.54) £1.37 (6.12)
Psychologist £54.4 (222.09)
Community psychiatrist nurse £3.04 (15.20) £79.80 (356.88)

Education welfare officer £6.01 (17.35)

Educational psychologist £1.49 (7.46)
Family liaison officer £1.96 (9.80) £58.8 (230.71)
Teacher £4.17 (17.17) £2.83 (14.16) £3.54 (10.90)
Audiology £25.88 (73.06)

Ophthalmology £4.28 (21.40)

Hospital A&E department £21.6 (96.60)
Occupational therapist £5.82 (24.01)
Housing department £8.16 (33.63) £1.58 (5.49)

Citizens Advice Bureau £0.78 (3.47)

a b
Other £143.52 (269.36) £30.90 (124.29) £93.93c (191.70)
Observations 17 25 20
a Only 13 observations.
b Only 21 observations.
c Only 19 observations.

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
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addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
Park, Southampton SO16 7NS, UK.
 APPENDIX 3

TABLE 108 Cost of other health and social care resources: child – period between assessment 2 (post treatment)
and assessment 3 (6-month follow-up)

Mean (SD)

Cost: child CCBT + MCBT CCBT + MCI CCBT

Family doctor £26.25 (43.83) £18.06 (30.70) £37.33 (71.96)

Social worker £151.07 (597.37)

Practice nurse £1.77 (5.85) £0.91 (5.00)

Psychologist £17.00 (96.17) £22.67 (101.54)

Psychiatrist £12.76 (69.93)

Education welfare officer £3.83 (18.31)

Educational psychologist £2.49 (13.62)

Family liaison officer £1.53 (8.66) £42.47 (189.88)

Teacher £13.28 (39.97) £12.56 (40.42) £21.25 (86.04)

Paediatrician £42.19 (133.27) £29.03 (112.38) £22.50 (123.24)

Audiology £3.44 (19.45) £10.65 (43.58)

Ophthalmology £3.34 (18.92) £10.70 (43.08)

Hospital A&E department £16.88 (39.84) £6.97 (26.97) £7.20 (27.40)

Occupational therapist
Paediatric dietitian £1.06 (6.01) £9.07 (49.66)

Paediatric physiotherapist £2.31 (13.08) £2.47 (13.51)

Paediatric play specialist £2.17 (12.25)

Community children’s nurse £2.91 (16.44)

Child and adolescent mental health worker £15.87 (75.09)

a b
Other £67.60 (123.91) £29.50 (74.99) £50.70c (132.05)

Observations 32 31 30
a Only 12 observations.
b Only 11 observations.
c Only 16 observations.

144
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 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

TABLE 109 Cost of other health and social care resources: mother – period between assessment 2 (post treatment)
and assessment 3 (6-month follow-up)

Mean (SD)

Cost: mother CCBT + MCBT CCBT + MCI CCBT

Family doctor £53.75 (70.10) £32.26 (41.85) £70.67 (157.46)

Social worker £82.40 (451.32)

Practice nurse £2.14 (6.13) £3.53 (7.88) £1.83 (5.94)

Psychologist £22.67 (101.54)

Psychiatrist £23.94 (94.19) £12.77 (69.93)

Community psychiatrist nurse £23.75 (134.35) £15.2 (83.25)

Education welfare officer £5.11 (18.72) £1.36 (7.46)

Educational psychologist £1.24 (6.81)

Family liaison officer £1.53 (8.66) £35.93 (187.77)

Teacher £14.39 (53.10) £5.71 (26.02) £2.36 (2.93)

Audiology £13.75 (54.11) £10.65 (59.27) £14.67 (80.33)

Ophthalmology £6.69 (26.32)

Hospital A&E department £13.50 (45.49) £6.97 (26.97) £7.20 (27.40)

Occupational therapist £5.50 (30.12)

Paediatric dietitian £2.13 (12.02)

Family therapist £1.53 (8.66)

Community children’s nurse £2.91 (16.44)

Citizens Advice Bureau £1.45 (8.22) £1.55 (8.49)

a b
Other £81.12 (135.73) £56.16 (138.08) £75.71c (185.15)

Observations 32 31 30
a Only 11 observations.
b Only 13 observations.
c Only 15 observations.

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
145
addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
Park, Southampton SO16 7NS, UK.
 APPENDIX 3

TABLE 110 Cost of other health and social care resources: child – period between assessment 3 (6-month
follow-up) and assessment 4 (12-month follow-up)

Mean (SD)

Cost: child CCBT + MCBT CCBT + MCI CCBT

Family doctor £38.26 (40.86) £13.91 (25.89) £24 (40.14)

Social worker £8.96 (42.95) £109.87 (601.76)

Practice nurse £2.98 (11.64) £3.65 (10.75)

Psychologist £5.91 (28.36) £11.83 (56.72) £77.07 (334.44)

Psychiatrist £12.77 (69.93)

Education welfare officer £0.68 (3.73)

Educational psychologist £1.62 (7.78) £1.62 (7.78)

Family liaison officer £6.39 (30.65) £37.57 (188.10)

Teacher £1.54 (7.38) £6.16 (20.40) £4.72 (15.37)

Paediatrician £29.35 (140.75) £78.26 (210.29) £15.00 (82.16)

Audiology £9.57 (45.87)

Ophthalmology £7.13 (39.07)

Hospital A&E department £4.70 (22.52) £4.70 (22.52) £3.60 (19.72)

Paediatric dietitian £7.93 (43.45)

Paediatric physiotherapist £3.22 (15.43)

Child and adolescent mental health worker £2.27 (12.42)

Primary mental health worker £2.27 (12.42)

a b
Other £4.27 (18.61) £4.27 (18.61) £24.69c (75.13)

Observations 23 23 30
a Only 19 observations.
b Only 19 observations.
c Only 23 observations.

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 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

TABLE 111 Cost of other health and social care resources: mother – period between assessment 3 (6-month
follow-up) and assessment 4 (12-month follow-up)

Mean (SD)

Cost: mother CCBT + MCBT CCBT + MCI CCBT

Family doctor £95.65 (139.47) £60.87 (78.97) £54.67 (78.95)

Social worker £44.78 (214.77) £68.67 (376.10)

Practice nurse £0.60 (2.85) £4.76 (17.32) £1.37 (4.18)

Psychologist £53.22 (255.22) £23.65 (113.43)

Psychiatrist £16.65 (79.86)

Education welfare officer £0.68 (3.73)

Educational psychologist £1.62 (7.78) £1.24 (6.81)

Family liaison officer £4.26 (14.12) £35.93 (187.77)

Teacher £4.62 (16.21) £26.17 (89.46) £4.72 (15.37)

Ophthalmology £3.57 (19.54)

Hospital A&E department £18.78 (53.03) £9.39 (45.04) £7.20 (39.44)

Occupational therapist £1.43 (6.88)

Housing department £1.72 (8.26) £0.66 (3.62)

Citizens Advice Bureau £0.67 (3.23) £0.52 (2.83)

Family centre £2.13 (10.22) £3.27 (17.89)

Home-Start £4.16 (19.93)

Other £57.94a (103.07) £29.89b (82.06) £35.27c (84.11)

Observations 23 23 30
a Only 21 observations.
b Only 19 observations.
c Only 23 observations.

TABLE 112 Time off school (days) for the child and time off work and usual activities (days) for the mother: period
between assessment 1A (baseline) and assessment 1B (mid-treatment)

Mean (SD)

Time off (days) CCBT + MCBT CCBT + MCI CCBT

Time off school (days): child 1.46 (1.97) 0.28 (0.92) 1.88 (2.91)

Time off work (days): mother 0.50a (1.38) 0.28b (0.92) 2.00 (6.42)

Time off usual activities (days): mother 1.14 (3.04) 0.57 (2.38) 0.78 (2.76)
Observations 35 47 32
a Only 34 observations.
b Only 45 observations.

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
147
addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
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 APPENDIX 3

TABLE 113 Time off school (days) for the child and time off work and usual activities (days) for the mother: period
between assessment 1B (mid-treatment) and assessment 2 (post treatment)

Mean (SD)

Time off (days) CCBT + MCBT CCBT + MCI CCBT

Time off school (days): child 2.12 (4.09) 1.84 (2.64) 3.38 (10.02)

Time off work (days): mother 0.41 (1.70) 0.72 (1.74) 2.65 (8.29)

Time off usual activities (days): mother 0.06 (0.24) 1.96 (6.09) 0.65 (2.68)

Observations 17 25 20

TABLE 114 Time off school (days) for the child and time off work and usual activities (days) for the mother: period
between assessment 2 (post treatment) and assessment 3 (6-month follow-up)

Mean (SD)

Time off (days) CCBT + MCBT CCBT + MCI CCBT

Time off school (days): child 3.38 (6.74) 1.32 (2.28) 2.55 (4.69)

Time off work (days): mother 0.59 (1.62) 0.42 (1.12) 3.03 (8.66)

Time off usual activities (days): mother 1.00 (2.75) 1.06 (3.72) 0.23 (1.28)

Observations 32 31 30

TABLE 115 Time off school (days) for the child and time off work and usual activities (days) for the mother: period
between assessment 3 (6-month follow-up) and assessment 4 (12-month follow-up)

Mean (SD)

Time off (days) CCBT + MCBT CCBT + MCI CCBT

Time off school (days): child 3.23 (4.82) 0.61 (1.53) 3.15 (6.34)
Time off work (days): mother 1.45 (3.29) 1.00 (3.12) 1.03a (2.38)

Time off usual activities (days): mother 0.64 (2.98) 1.68 (1.99) 1.69a (6.43)

Observations 22 23 30
a Only 29 observations.

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 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

TABLE 116 Cost–utility (health service perspective): ITT approach – CCBT + MCBT vs. CCBT

CUA results CCBT + MCBT (n = 69), mean (SE) CCBT (n = 71), mean (SE)

Cost of intervention £1888.84 (78.65) £1092.25 (61.88)

QALY gain 0.794 (0.022) 0.827 (0.024)

Incremental cost (95% CI) £796.59 (£599.48 to £993.70)

Incremental benefit, QALY gain (95% CI) –0.033 (–0.101 to 0.035)

ICER, incremental cost per QALY gain –£24,139

(95% CI) bootstrap method Lower limit, £47,106; upper limit, –£10,094
(95% CI) Fieller’s method Lower limit, –£9251; upper limit, £46,271

NMB for WTP = £20,000 –0.033 × £20,000 – £796.59 = –£1456.00

NMB for WTP = £30,000 –0.033 × £30,000 – £796.59 = –£1786.59

SE, standard error; WTP, willingness to pay.

TABLE 117 Cost–utility (health service perspective): ITT approach – CCBT + MCI vs. CCBT

CUA results CCBT + MCI (n = 71), mean (SE) CCBT (n = 71), mean (SE)
Cost of intervention £1899.95 (80.72) £1891.30 (87.14)

QALY gain 0.855 (0.018) 0.827 (0.024)

Incremental cost (95% CI) £807.70 (£606.55 to £1008.85)

Incremental benefit, QALY gain (95% CI) 0.028 (–0.030 to 0.086)

ICER, incremental cost per QALY gain £28,846

(95% CI) bootstrap method Lower limit, £10,129; upper limit, –£41,264

(95% CI) Fieller’s method Lower limit, £10,207; upper limit, –£41,499
NMB for WTP = £20,000 0.028 × £20,000 – £807.70 = –£247.70

NMB for WTP = £30,000 0.028 × £30,000 – £807.70 = £32.30

SE, standard error; WTP, willingness to pay.

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
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 APPENDIX 3

1284.20

Difference in cost (£)

856.13
Replicates
LL
PE_line
UL
428.07

0
–0.113 –0.068 –0.024 0.021 0.065
Difference in effect

FIGURE 14 Cost-effectiveness plane showing bootstrapped replicates of the ICER: ITT analysis – CCBT + MCBT vs.
CCBT. LL, lower limit; PE, point estimate; UL, upper limit.

1.0

0.75
% acceptable

0.50

0.25

0.0

0 25 50 75 100 125
Willingness to pay (£000)

FIGURE 15 Cost-effectiveness acceptability curve showing the probability that the intervention is cost-effective at
different willingness-to-pay thresholds: ITT analysis – CCBT + MCBT vs. CCBT.

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 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

LL
NMB (£000)

NMB
–5 UL

–10

0 25 50 75 100 125
Willingness to pay (£000)

FIGURE 16 Net monetary benefit curve and limit curves: ITT analysis – CCBT + MCBT vs. CCBT. LL, lower limit;
UL, upper limit.

1278.90
Difference in cost (£)

852.60 Replicates
LL
PE_line
UL

426.30

0.00
–0.057 –0.005 0.047 0.099 0.150
Difference in effect

FIGURE 17 Cost-effectiveness plane showing bootstrapped replicates of the ICER: ITT analysis – CCBT + MCI vs.
CCBT. LL, lower limit; PE, point estimate; UL, upper limit.

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
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 APPENDIX 3

1.00

0.75
% acceptable

0.50

0.25

0.0

0 25 50 75 100 125
Willingness to pay (£000)

FIGURE 18 Cost-effectiveness acceptability curve showing the probability that the intervention is cost-effective at
different willingness-to-pay thresholds: ITT analysis – CCBT + MCI vs. CCBT.

10

5
LL
NMB (£000)

NMB
UL

–5
0 25 50 75 100 125
Willingness to pay (£000)

FIGURE 19 Net monetary benefit curve and limit curves: ITT analysis – CCBT + MCI vs. CCBT. LL, lower limit;
UL, upper limit.

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 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

Appendix 4 Teacher-reported questionnaire

Child adjustment to school: teacher report

Instructions
For each item mark the box for not true, somewhat true or certainly true. It would help us if you answered
all items as best you can, even if you are not absolutely certain or the item seems daft! Please give your
answers on the basis of the child’s behaviour over the previous 2 weeks of school.

Not true Somewhat true Certainly true

Avoids or gets worried about presenting work or showing things to

the class

Avoids or gets worried about participating in group or sports activities

Avoids or gets worried about approaching a group of children to ask to
join in

Avoids or gets worried about standing up for him/herself with peers

Avoids or gets worried about answering questions in class

Avoids or gets worried about speaking in class

Avoids or gets worried about asking questions in class

Avoids or gets worried about telling a teacher if he/she doesn’t

understand something

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
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 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

Appendix 5 Summary statistics

TABLE 118 Descriptive statistics: SCAS questionnaires

Questionnaire Treatment n n missing Mean (SD) Median (IQR) Minimum Maximum

SCAS-c

Total score baseline CCBT 67 4 40.24 (21.29) 35.0 (24.0–53.0) 2 105

CCBT + MCBT 67 2 41.33 (18.26) 41.0 (29.0–56.0) 7 80

CCBT + MCI 69 2 39.16 (17.38) 39.0 (29.0–47.0) 4 92

Total score 6 months CCBT 44 27 21.05 (16.24) 18.0 (8.0–28.5) 0 73

CCBT + MCBT 43 26 24.42 (17.41) 19.0 (12.0–39.0) 0 63

CCBT + MCI 43 28 23.88 (17.37) 22.0 (9.0–35.0) 1 67

Total score 12 months CCBT 33 38 18.24 (13.31) 16.0 (9.0–27.0) 1 54

CCBT + MCBT 34 35 23.09 (14.92) 21.0 (10.0–34.0) 0 52

CCBT + MCI 39 32 21.15 (18.65) 15.0 (9.0–34.0) 0 68

SCAS-c/p

Total score baseline CCBT 64 7 43.17 (15.64) 43.0 (32.5–50.0) 16 94

CCBT + MCBT 63 6 42.19 (15.53) 39.0 (32.0–50.0) 17 82

CCBT + MCI 65 6 41.60 (16.75) 40.0 (29.0–52.0) 16 94

Total score 6 months CCBT 40 31 22.40 (16.33) 19.0 (14.0–27.5) 1 93

CCBT + MCBT 43 26 23.21 (13.53) 19.0 (14.0–31.0) 3 61

CCBT + MCI 39 32 22.26 (11.19) 22.0 (14.0–28.0) 5 51

Total score 12 months CCBT 34 37 19.44 (13.14) 15.5 (10.0–29.0) 1 51

CCBT + MCBT 32 37 24.63 (15.37) 25.0 (12.0–32.5) 1 66

CCBT + MCI 36 35 18.28 (12.80) 17.0 (9.0–24.0) 2 58

CCBT + MCBT 20 49 4.05 (3.02) 3.5 (2.0–5.5) 0 12

CCBT + MCI 26 45 5.04 (3.46) 5.0 (3.0–7.0) 0 13

SCAS-t

Total score baseline CCBT 25 46 17.60 (13.39) 15.0 (10.0–22.0) 0 49

CCBT + MCBT 37 32 14.38 (14.57) 9.0 (5.0–16.0) 1 66

CCBT + MCI 42 29 18.67 (12.98) 15.0 (10.0–26.0) 0 47

Total score 6 months CCBT 11 60 11.91 (13.16) 6.0 (1.0–15.0) 0 43

CCBT + MCBT 16 53 8.63 (7.05) 6.5 (3.5–12.0) 2 29

CCBT + MCI 22 49 11.68 (11.51) 7.0 (4.0–16.0) 0 46

Total score 12 months CCBT 9 62 9.44 (9.86) 6.0 (5.0–8.0) 1 32

CCBT + MCBT 8 61 15.75 (11.51) 14.0 (8.0–20.5) 2 39

CCBT + MCI 10 61 7.70 (5.19) 7.5 (3.0–11.0) 0 17
IQR, interquartile range.

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
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 APPENDIX 5

TABLE 119 Descriptive statistics: CAIS questionnaires

Questionnaire Treatment n n missing Mean (SD) Median (IQR) Minimum Maximum

CAIS-c

Total score baseline CCBT 66 5 18.29 (12.83) 16.5 (9.0–24.0) 1 58

CCBT + MCBT 67 2 23.15 (16.34) 20.0 (10.0–37.0) 0 70

CCBT + MCI 68 3 18.91 (14.02) 15.0 (7.5–28.0) 0 63

Total score 6 months CCBT 42 29 7.48 (7.39) 5.0 (2.0–11.0) 0 27

CCBT + MCBT 43 26 10.02 (8.56) 8.0 (3.0–14.0) 0 29

CCBT + MCI 43 28 9.74 (9.39) 7.0 (2.0–16.0) 0 39

Total score 12 months CCBT 32 39 6.75 (7.36) 4.0 (1.0–11.0) 0 29

CCBT + MCBT 33 36 11.82 (15.16) 7.0 (2.0–18.0) 0 78

CCBT + MCI 38 33 7.82 (11.23) 3.5 (1.0–10.0) 0 49

CAIS-c/p

Total score baseline CCBT 58 13 23.17 (16.04) 18.5 (11.0–32.0) 1 66

CCBT + MCBT 56 13 25.46 (15.07) 25.0 (15.0–34.5) 0 60

CCBT + MCI 58 13 20.55 (12.66) 17.0 (10.0–28.0) 1 58

Total score 6 months CCBT 40 31 13.18 (12.87) 9.0 (3.0–22.0) 0 54

CCBT + MCBT 43 26 11.65 (9.67) 9.0 (5.0–16.0) 1 44

CCBT + MCI 42 29 11.17 (9.17) 9.0 (4.0–18.0) 0 38

Total score 12 months CCBT 33 38 11.48 (12.14) 9.0 (3.0–16.0) 0 58

CCBT + MCBT 33 36 14.39 (12.15) 14.0 (6.0–19.0) 0 45

CCBT + MCI 38 33 7.92 (6.58) 7.0 (3.0–13.0) 0 24

IQR, interquartile range.

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TABLE 120 Descriptive statistics: SDQ conduct questionnaires

Questionnaire Treatment n n missing Mean (SD) Median (IQR) Minimum Maximum

SDQ-c conduct

Score baseline CCBT 68 3 2.97 (2.01) 3.0 (1.0–4.0) 0 8

CCBT + MCBT 66 3 3.05 (1.88) 3.0 (2.0–4.0) 0 8

CCBT + MCI 70 1 2.84 (1.72) 3.0 (2.0–4.0) 0 8

Score 6 months CCBT 44 27 2.07 (1.61) 2.0 (1.0–3.0) 0 6

CCBT + MCBT 44 25 2.05 (1.38) 2.0 (1.0–3.0) 0 6

CCBT + MCI 43 28 2.14 (1.93) 2.0 (1.0–3.0) 0 6

Score 12 months CCBT 33 38 1.64 (1.48) 2.0 (0.0–3.0) 0 5

CCBT + MCBT 35 34 2.06 (1.66) 2.0 (1.0–2.0) 0 8

CCBT + MCI 39 32 1.95 (2.31) 1.0 (0.0–3.0) 0 8

SDQ-c/p conduct

Score baseline CCBT 65 6 2.46 (1.96) 2.0 (1.0–3.0) 0 8

CCBT + MCBT 65 4 3.05 (1.82) 3.0 (2.0–4.0) 0 9

CCBT + MCI 70 1 2.57 (1.88) 2.0 (1.0–4.0) 0 8

Score 6 months CCBT 41 30 2.00 (1.90) 2.0 (1.0–3.0) 0 8

CCBT + MCBT 43 26 1.77 (1.62) 1.0 (1.0–3.0) 0 6

CCBT + MCI 42 29 1.45 (1.40) 1.0 (0.0–2.0) 0 6

Score 12 months CCBT 34 37 1.26 (1.64) 1.0 (0.0–2.0) 0 8

CCBT + MCBT 34 35 1.97 (1.47) 2.0 (1.0–3.0) 0 5

CCBT + MCI 38 33 1.82 (2.04) 1.0 (0.0–3.0) 0 8

IQR, interquartile range.

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
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 APPENDIX 5

TABLE 121 Descriptive statistics: SMFQ questionnaires

Questionnaire Treatment n n missing Mean (SD) Median (IQR) Minimum Maximum

SMFQ-c

Total score baseline CCBT 67 4 7.81 (6.76) 5.0 (2.0–13.0) 0 24

CCBT + MCBT 68 1 9.03 (5.52) 8.5 (5.0–12.0) 0 24

CCBT + MCI 69 2 7.42 (5.70) 6.0 (3.0–10.0) 0 23

Total score 6 months CCBT 43 28 4.51 (5.29) 3.0 (0.0–7.0) 0 19

CCBT + MCBT 44 25 5.20 (4.99) 4.5 (0.5–10.0) 0 16

CCBT + MCI 41 30 4.00 (5.17) 1.0 (0.0–7.0) 0 22

Total score 12 months CCBT 31 40 3.00 (3.91) 1.0 (0.0–5.0) 0 12

CCBT + MCBT 35 34 4.31 (5.42) 3.0 (0.0–6.0) 0 25

CCBT + MCI 38 33 4.61 (6.74) 1.0 (0.0–6.0) 0 26

SMFQ-c/p

Total score baseline CCBT 59 12 9.39 (6.61) 7.0 (4.0–14.0) 0 24

CCBT + MCBT 58 11 10.74 (7.24) 10.0 (5.0–15.0) 0 26

CCBT + MCI 62 9 8.79 (7.25) 7.0 (3.0–14.0) 0 25

Total score 6 months CCBT 41 30 5.12 (5.81) 3.0 (1.0–9.0) 0 25

CCBT + MCBT 43 26 4.65 (5.25) 3.0 (1.0–7.0) 0 20

CCBT + MCI 42 29 4.33 (4.74) 3.5 (1.0–7.0) 0 23

Total score 12 months CCBT 34 37 4.06 (5.43) 1.5 (0.0–6.0) 0 20

CCBT + MCBT 34 35 6.29 (5.84) 5.0 (1.0–10.0) 0 22

CCBT + MCI 38 33 3.71 (4.78) 1.0 (0.0–6.0) 0 18

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TABLE 122 Summary of behavioural scores at baseline and assessment 2, and the change from baseline to
assessment 2

Questionnaire Treatment n Mean (SD) Median (IQR) Minimum Maximum

Positive behaviour

Difference CCBT 42 0.01 (0.40) –0.01 (–0.26 to 0.35) –1.20 0.75

baseline–assessment 2
CCBT + MCBT 45 0.01 (0.33) 0.02 (–0.28 to 0.24) –0.57 0.94
CCBT + MCI 49 0.08 (0.42) 0.10 (–0.19 to 0.37) –1.19 1.04

Score 2 CCBT 42 3.17 (0.36) 3.22 (2.93 to 3.43) 2.32 3.82

CCBT + MCBT 45 3.07 (0.36) 3.04 (2.86 to 3.31) 2.30 3.96

CCBT + MCI 49 3.16 (0.47) 3.17 (2.95 to 3.49) 1.81 4.34

Total score baseline CCBT 42 3.16 (0.45) 3.14 (2.88 to 3.47) 2.08 4.03

CCBT + MCBT 45 3.06 (0.39) 3.04 (2.75 to 3.38) 2.29 4.03

CCBT + MCI 49 3.08 (0.55) 3.11 (2.74 to 3.39) 1.89 4.33

Overprotection

Difference CCBT 42 –0.04 (0.18) 0.00 (–0.07 to 0.00) –1.00 0.28

baseline–assessment 2
CCBT + MCBT 45 –0.03 (0.10) 0.00 (–0.02 to 0.00) –0.33 0.22

CCBT + MCI 49 –0.04 (0.09) 0.00 (–0.07 to 0.00) –0.33 0.07

Score 2 CCBT 42 1.04 (0.10) 1.00 (1.00 to 1.00) 1.00 1.50

CCBT + MCBT 45 1.02 (0.05) 1.00 (1.00 to 1.00) 1.00 1.22

CCBT + MCI 49 1.01 (0.03) 1.00 (1.00 to 1.00) 1.00 1.11

Total score baseline CCBT 42 1.08 (0.17) 1.00 (1.00 to 1.11) 1.00 2.00

CCBT + MCBT 45 1.05 (0.09) 1.00 (1.00 to 1.08) 1.00 1.33

CCBT + MCI 49 1.05 (0.09) 1.00 (1.00 to 1.07) 1.00 1.33

Promotion of avoidance

Difference CCBT 42 –0.04 (0.13) 0.00 (–0.11 to 0.00) –0.47 0.28

baseline–assessment 2
CCBT + MCBT 45 –0.01 (0.13) 0.00 (–0.07 to 0.00) –0.53 0.33

CCBT + MCI 49 –0.04 (0.11) 0.00 (–0.07 to 0.00) –0.40 0.13

Score 2 CCBT 42 1.06 (0.10) 1.00 (1.00 to 1.08) 1.00 1.44

CCBT + MCBT 45 1.05 (0.09) 1.00 (1.00 to 1.07) 1.00 1.33

CCBT + MCI 49 1.03 (0.06) 1.00 (1.00 to 1.07) 1.00 1.33

Total score baseline CCBT 42 1.10 (0.12) 1.08 (1.00 to 1.13) 1.00 1.47

CCBT + MCBT 45 1.06 (0.09) 1.00 (1.00 to 1.08) 1.00 1.53

CCBT + MCI 49 1.06 (0.10) 1.00 (1.00 to 1.11) 1.00 1.40

Intrusiveness
Difference CCBT 42 –0.06 (0.47) –0.04 (–0.28 to 0.13) –1.45 1.28
baseline–assessment 2
CCBT + MCBT 45 0.01 (0.46) 0.05 (–0.14 to 0.28) –1.08 1.00

CCBT + MCI 49 –0.10 (0.46) –0.05 (–0.27 to 0.13) –1.43 0.87

Score 2 CCBT 42 1.52 (0.44) 1.48 (1.20 to 1.84) 1.00 2.88

CCBT + MCBT 45 1.60 (0.39) 1.47 (1.31 to 1.84) 1.00 2.45

CCBT + MCI 49 1.48 (0.38) 1.41 (1.13 to 1.78) 1.00 2.43

continued

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
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addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
Park, Southampton SO16 7NS, UK.
 APPENDIX 5

TABLE 122 Summary of behavioural scores at baseline and assessment 2, and the change from baseline to
assessment 2 (continued )

Questionnaire Treatment n Mean (SD) Median (IQR) Minimum Maximum

Total score baseline CCBT 42 1.58 (0.52) 1.48 (1.16 to 1.88) 1.00 2.93
CCBT + MCBT 45 1.60 (0.50) 1.40 (1.20 to 1.87) 1.00 2.86

CCBT + MCI 49 1.58 (0.49) 1.51 (1.16 to 1.80) 1.00 2.99

Expressed anxiety

Difference CCBT 42 0.03 (0.34) 0.04 (–0.23 to 0.22) –0.64 0.96

baseline–assessment 2
CCBT + MCBT 45 0.02 (0.38) –0.01 (–0.17 to 0.24) –1.16 0.94

CCBT + MCI 49 –0.04 (0.40) –0.04 (–0.26 to 0.19) –1.03 1.43

Score 2 CCBT 42 1.61 (0.36) 1.59 (1.37 to 1.73) 1.07 2.74

CCBT + MCBT 45 1.64 (0.41) 1.56 (1.33 to 1.92) 1.00 2.66

CCBT + MCI 49 1.59 (0.36) 1.57 (1.41 to 1.79) 1.00 2.96

Total score baseline CCBT 42 1.58 (0.27) 1.49 (1.37 to 1.75) 1.18 2.23

CCBT + MCBT 45 1.62 (0.33) 1.54 (1.40 to 1.86) 1.11 2.62

CCBT + MCI 49 1.63 (0.38) 1.53 (1.36 to 1.83) 1.00 2.60

Quality of relationship

Difference CCBT 42 0.00 (0.36) 0.05 (–0.20 to 0.22) –0.83 0.87

baseline–assessment 2
CCBT + MCBT 45 0.06 (0.37) 0.04 (–0.13 to 0.30) –0.72 0.83
CCBT + MCI 49 0.01 (0.44) –0.02 (–0.33 to 0.31) –0.95 1.42

Score 2 CCBT 42 3.37 (0.33) 3.38 (3.17 to 3.63) 2.40 3.93

CCBT + MCBT 45 3.36 (0.42) 3.38 (3.13 to 3.67) 2.36 4.32

CCBT + MCI 49 3.34 (0.39) 3.33 (3.20 to 3.60) 2.36 4.13

Total score baseline CCBT 42 3.37 (0.40) 3.44 (3.04 to 3.67) 2.53 4.07

CCBT + MCBT 45 3.30 (0.42) 3.37 (2.93 to 3.56) 2.27 4.00

CCBT + MCI 49 3.33 (0.51) 3.40 (3.08 to 3.56) 1.91 4.55

POI

Difference CCBT 34 –5.94 (10.15) –6.0 (–11.0 to 2.0) –36 9

baseline–assessment 2
CCBT + MCBT 38 –6.53 (11.26) –6.0 (–15.0 to 0.0) –32 35

CCBT + MCI 34 –10.35 (10.22) –8.5 (–15.0 to 4.0) –41 7

Score 2 CCBT 34 21.74 (13.27) 20.0 (12.0 to 32.0) 2 56

CCBT + MCBT 38 21.82 (13.87) 20.0 (10.0 to 28.0) 3 59

CCBT + MCI 34 17.76 (9.18) 16.5 (10.0 to 25.0) 1 39

Total score baseline CCBT 34 27.68 (13.45) 27.0 (17.0 to 40.0) 5 49

CCBT + MCBT 38 28.34 (11.58) 29.5 (20.0 to 35.0) 8 54

CCBT + MCI 34 28.12 (11.99) 27.5 (19.0 to 36.0) 4 54

IQR, interquartile range; POI, Parent Over-Involvement Questionnaire.

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 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

TABLE 123 Summary of mothers’ self-report questionnaires at baseline and assessment 1B, and change from
baseline to assessment 1B

Questionnaire Treatment n Mean (SD) Median (IQR) Minimum Maximum

PSWQ

Difference CCBT 40 –3.4 (10.2) –2.5 (–7.0 to 2.5) –37 18

baseline–assessment 1B
CCBT + MCBT 42 –5.3 (12.5) –1.5 (–12.0 to 3.0) –41 17
CCBT + MCI 44 –3.0 (8.0) –3.0 (–8.0 to 4.5) –20 9

Self-report total score CCBT 40 35.9 (13.8) 38.0 (25.0 to 47.0) 9 64

assessment 1B
CCBT + MCBT 42 35.6 (14.3) 36.0 (25.0 to 45.0) 12 64

CCBT + MCI 44 33.9 (13.5) 35.0 (22.0 to 46.0) 3 59

Self-report total CCBT 40 39.2 (13.7) 41.5 (28.5 to 49.5) 15 64

score baseline
CCBT + MCBT 42 40.9 (13.4) 42.0 (34.0 to 52.0) 6 62

CCBT + MCI 44 36.8 (13.2) 36.5 (28.5 to 45.5) 8 62

SIAS

Difference CCBT 41 –0.9 (8.4) –1.0 (–4.0 to 2.0) –23 22

baseline–assessment 1B
CCBT + MCBT 44 –1.6 (8.7) –1.5 (–6.0 to 4.5) –28 15

CCBT + MCI 47 –0.1 (8.3) 0.0 (–6.0 to 5.0) –21 16

Self-report total score CCBT 41 22.9 (14.2) 21.0 (12.0 to 30.0) 3 67

assessment 1B
CCBT + MCBT 44 25.0 (13.5) 25.0 (14.5 to 31.5) 4 63

CCBT + MCI 47 23.5 (14.6) 18.0 (13.0 to 36.0) 0 62

Self-report total CCBT 41 23.8 (12.8) 23.0 (14.0 to 31.0) 1 55
score baseline
CCBT + MCBT 44 26.5 (15.4) 24.0 (13.5 to 38.5) 6 66

CCBT + MCI 47 23.7 (13.7) 22.0 (15.0 to 31.0) 0 61

SPS

Difference CCBT 41 –0.9 (9.5) 0.0 (–5.0 to 2.0) –31 26

baseline–assessment 1B
CCBT + MCBT 45 –0.6 (7.2) 0.0 (–6.0 to 3.0) –16 18

CCBT + MCI 46 0.5 (7.3) 0.5 (–3.0 to 2.0) –22 22

Self-report total score CCBT 41 13.5 (12.4) 9.0 (4.0 to 20.0) 0 53
assessment 1B
CCBT + MCBT 45 16.6 (14.1) 14.0 (6.0 to 26.0) 0 65

CCBT + MCI 46 13.7 (12.7) 10.0 (4.0 to 18.0) 0 47

Self-report total CCBT 41 14.4 (11.5) 12.0 (5.0 to 21.0) 0 42

score baseline
CCBT + MCBT 45 17.2 (13.0) 15.0 (7.0 to 26.0) 0 47

CCBT + MCI 46 13.2 (11.7) 9.0 (4.0 to 22.0) 0 45

DASS-21
Depression score CCBT 38 –1.7 (6.9) –1.0 (–6.0 to 0.0) –20 18
difference
baseline–assessment 1B CCBT + MCBT 43 –1.9 (5.2) –2.0 (–6.0 to 0.0) –10 10

CCBT + MCI 45 –1.7 (5.6) –2.0 (–6.0 to 2.0) –16 10

Self-report depression CCBT 38 10.0 (9.6) 8.0 (4.0 to 14.0) 0 42

score assessment 1B
CCBT + MCBT 43 9.8 (9.7) 8.0 (2.0 to 14.0) 0 36

CCBT + MCI 45 10.2 (8.0) 8.0 (4.0 to 14.0) 0 32

continued

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
161
addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
Park, Southampton SO16 7NS, UK.
 APPENDIX 5

TABLE 123 Summary of mothers’ self-report questionnaires at baseline and assessment 1B, and change from
baseline to assessment 1B (continued )

Questionnaire Treatment n Mean (SD) Median (IQR) Minimum Maximum

Self-report depression CCBT 38 11.7 (8.8) 10.0 (6.0 to 14.0) 0 40

score baseline
CCBT + MCBT 43 11.7 (9.2) 8.0 (6.0 to 18.0) 0 40

CCBT + MCI 45 11.9 (10.3) 10.0 (4.0 to 16.0) 0 42

Anxiety score difference CCBT 38 –0.3 (6.1) 0.0 (–2.0 to 2.0) –16 16
baseline–assessment 1B
CCBT + MCBT 44 –2.3 (6.7) –2.0 (–6.0 to 2.0) –22 12

CCBT + MCI 45 –1.7 (6.8) –2.0 (–4.0 to 2.0) –30 12

Self-report anxiety score CCBT 38 7.3 (9.0) 6.0 (0.0 to 8.0) 0 40

assessment 1B
CCBT + MCBT 44 8.2 (8.2) 6.0 (2.0 to 12.0) 0 36
CCBT + MCI 45 7.1 (8.1) 4.0 (2.0 to 8.0) 0 32

Self-report anxiety CCBT 38 7.6 (7.3) 5.0 (0.0 to 14.0) 0 24

score baseline
CCBT + MCBT 44 10.5 (8.0) 9.0 (4.0 to 16.0) 0 34

CCBT + MCI 45 8.8 (8.4) 6.0 (2.0 to 14.0) 0 34

Stress score difference CCBT 41 –1.4 (6.7) –2.0 (–6.0 to 2.0) –16 14
baseline–assessment 1B
CCBT + MCBT 45 –1.9 (9.1) –2.0 (–8.0 to 2.0) –20 28

CCBT + MCI 45 –0.7 (5.9) –2.0 (–4.0 to 2.0) –16 16

Self-report stress score CCBT 41 16.0 (9.9) 16.0 (10.0 to 22.0) 0 42

assessment 1B
CCBT + MCBT 45 16.0 (9.3) 14.0 (8.0 to 22.0) 0 40

CCBT + MCI 45 15.4 (8.2) 16.0 (8.0 to 22.0) 0 32

Self-report stress CCBT 41 17.3 (10.1) 16.0 (10.0 to 22.0) 0 42

score baseline
CCBT + MCBT 45 17.9 (9.9) 18.0 (10.0 to 22.0) 2 42

CCBT + MCI 45 16.1 (9.0) 14.0 (10.0 to 22.0) 0 40

IQR, interquartile range.

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 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

TABLE 124 Summary of mothers’ self-report questionnaires at baseline and assessment 2, and change from
baseline to assessment 2

Questionnaire Treatment n Mean (SD) Median (IQR) Minimum Maximum

PSWQ

Difference CCBT 35 –6.9 (12.0) –6.0 (–13.0 to –1.0) –40 21

baseline–assessment 2
CCBT + MCBT 41 –7.3 (12.5) –5.0 (–14.0 to 1.0) –37 13
CCBT + MCI 35 –6.0 (9.3) –8.0 (–11.0 to –2.0) –23 16

Self-report total score 2 CCBT 35 31.5 (13.7) 29.0 (19.0 to 42.0) 10 59

CCBT + MCBT 41 33.3 (15.2) 33.0 (23.0 to 43.0) 1 64

CCBT + MCI 35 30.9 (12.9) 30.0 (22.0 to 43.0) 2 54

Self-report total CCBT 35 38.4 (13.2) 41.0 (29.0 to 49.0) 15 60

score baseline
CCBT + MCBT 41 40.6 (12.9) 42.0 (34.0 to 50.0) 6 64

CCBT + MCI 35 36.9 (13.7) 36.0 (28.0 to 47.0) 8 64

SIAS

Difference CCBT 34 –2.9 (10.8) –4.0 (–8.0 to –1.0) –35 28

baseline–assessment 2
CCBT + MCBT 40 –5.5 (13.5) –2.0 (–11.5 to 3.0) –41 17

CCBT + MCI 36 –4.5 (8.0) –5.5 (–10.0 to 0.0) –29 16

Self-report total score 2 CCBT 34 20.5 (14.7) 17.0 (11.0 to 30.0) 0 66

CCBT + MCBT 40 22.3 (14.5) 16.5 (12.5 to 29.0) 3 65

CCBT + MCI 36 19.1 (12.8) 17.0 (10.5 to 29.0) 0 48

Self-report total CCBT 34 23.4 (13.4) 31.0 (22.5 to 31.0) 1 55
score baseline
CCBT + MCBT 40 27.9 (15.8) 26.5 (14.0 to 39.0) 6 66

CCBT + MCI 36 23.7 (14.4) 22.5 (14.0 to 29.0) 0 61

SPS

Difference CCBT 35 –3.6 (8.0) –3.0 (–8.0 to –1.0) –21 18

baseline–assessment 2
CCBT + MCBT 41 –4.7 (7.9) –3.0 (–9.0 to 0.0) –28 12

CCBT + MCI 36 –1.8 (7.1) –2.0 (–7.0 to 1.0) –16 28

Self-report total score 2 CCBT 35 9.7 (9.7) 7.0 (2.0 to 13.0) 0 45

CCBT + MCBT 41 11.8 (11.5) 8.0 (3.0 to 16.0) 0 52

CCBT + MCI 36 11.0 (10.9) 6.0 (3.0 to 19.5) 0 43

Self-report total CCBT 35 13.3 (10.9) 12.0 (5.0 to 18.0) 0 42

score baseline
CCBT + MCBT 41 16.5 (12.7) 14.0 (7.0 to 23.0) 0 47

CCBT + MCI 36 12.8 (11.3) 9.5 (3.5 to 19.0) 0 45

DASS-21
Depression score CCBT 32 –3.2 (8.8) –4.0 (–1.00 to 1.0) –24 18
difference
baseline–assessment 2 CCBT + MCBT 36 –4.0 (7.0) –4.0 (–6.0 to 0.0) –20 14

CCBT + MCI 33 –2.1 (5.2) –2.0 (–4.0 to 0.0) –14 8

Self-report depression CCBT 32 8.9 (10.6) 4.0 (2.0 to 14.0) 0 42

score assessment 2
CCBT + MCBT 36 8.2 (8.8) 6.0 (2.0 to 12.0) 0 40

CCBT + MCI 33 7.8 (7.3) 6.0 (2.0 to 14.0) 0 26

continued

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
163
addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
Park, Southampton SO16 7NS, UK.
 APPENDIX 5

TABLE 124 Summary of mothers’ self-report questionnaires at baseline and assessment 2, and change from
baseline to assessment 2 (continued )

Questionnaire Treatment n Mean (SD) Median (IQR) Minimum Maximum

Self-report depression CCBT 32 12.1 (10.2) 10.0 (4.0 to 17.0) 0 40

score baseline
CCBT + MCBT 36 12.1 (8.8) 9.0 (6.0 to 17.0) 2 40

CCBT + MCI 33 9.9 (8.2) 10.0 (4.0 to 14.0) 0 28

Anxiety score difference CCBT 32 –0.6 (7.4) –2.0 (–4.0 to 2.0) –20 18
baseline–assessment 2
CCBT + MCBT 36 –3.1 (6.8) –4.0 (–7.0 to 0.0) –14 26

CCBT + MCI 33 –2.0 (5.0) –2.0 (–4.0 to 0.0) –14 12

Self-report anxiety score CCBT 32 7.3 (10.3) 3.0 (0.0 to 9.0) 0 42

assessment 2
CCBT + MCBT 36 6.7 (8.0) 5.0 (0.0 to 11.0) 0 40
CCBT + MCI 33 4.5 (5.3) 2.0 (0.0 to 8.0) 0 16

Self-report anxiety CCBT 32 7.9 (8.0) 5.0 (2.0 to 14.0) 0 30

score baseline
CCBT + MCBT 36 9.8 (6.8) 9.0 (4.0 to 15.0) 0 24

CCBT + MCI 33 6.5 (5.0) 6.0 (2.0 to 10.0) 0 18

Stress score difference CCBT 34 –3.8 (8.0) –4.0 (–8.0 to 0.0) –22 14
baseline–assessment 2
CCBT + MCBT 41 –2.5 (6.5) –4.0 (–6.0 to 0.0) –14 12

CCBT + MCI 35 –2.5 (6.7) –2.0 (–6.0 to 0.0) –16 12

Self-report stress score CCBT 34 12.9 (9.2) 11.0 (6.0 to 20.0) 0 32

assessment 2
CCBT + MCBT 41 14.7 (9.4) 14.0 (10.0 to 18.0) 0 42

CCBT + MCI 35 12.1 (8.8) 12.0 (4.0 to 20.0) 0 28

Self-report stress CCBT 34 16.7 (9.7) 16.0 (10.0 to 22.0) 0 40

score baseline
CCBT + MCBT 41 17.2 (8.4) 18.0 (12.0 to 22.0) 2 36

CCBT + MCI 35 14.6 (8.2) 12.0 (8.0 to 20.0) 0 32

IQR, interquartile range.

TABLE 125 Summary of cognition scores at baseline and assessment 2, and the change from baseline to
assessment 2

Questionnaire Treatment n Mean (SD) Median (IQR) Minimum Maximum

Pre-task ‘child scared’

Difference CCBT 40 –0.70 (1.78) –0.67 (–2.00 to 0.33) –3.67 4.00

baseline–assessment 2
CCBT + MCBT 45 –1.10 (1.62) –1.00 (–1.67 to 0.00) –6.33 1.67

CCBT + MCI 46 –1.47 (1.55) –1.33 (–2.33 to –0.33) –5.33 1.00

Score post treatment CCBT 40 3.62 (1.58) 3.33 (2.50 to 5.00) 1.00 7.67

CCBT + MCBT 45 3.10 (1.57) 3.00 (1.67 to 4.33) 0.00 7.00

CCBT + MCI 46 3.18 (1.69) 3.33 (2.00 to 4.33) 0.00 6.67

Total score baseline CCBT 40 4.31 (1.86) 4.33 (3.00 to 5.50) 0.50 8.33

CCBT + MCBT 45 4.21 (1.81) 4.00 (3.00 to 5.33) 0.33 8.33

CCBT + MCI 46 4.65 (1.82) 4.67 (3.67 to 6.00) 0.00 8.33

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 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

TABLE 125 Summary of cognition scores at baseline and assessment 2, and the change from baseline to
assessment 2 (continued )

Questionnaire Treatment n Mean (SD) Median (IQR) Minimum Maximum

Pre-task ‘mother anxious’

Difference CCBT 40 –0.85 (1.63) –1.00 (–2.33 to 0.00) –3.33 3.33
baseline–assessment 2
CCBT + MCBT 45 –1.46 (1.95) –1.33 (–2.67 to 0.00) –7.00 2.33

CCBT + MCI 46 –1.42 (1.73) –1.33 (–2.67 to –0.33) –5.67 2.33

Score post treatment CCBT 40 3.03 (1.41) 3.00 (2.00 to 4.00) 0.00 6.67

CCBT + MCBT 45 2.56 (1.89) 2.33 (1.33 to 3.33) 0.00 8.67

CCBT + MCI 46 2.52 (1.81) 2.50 (1.00 to 3.67) 0.00 7.00

Total score baseline CCBT 40 3.88 (1.74) 4.17 (3.00 to 5.17) 0.00 7.67
CCBT + MCBT 45 4.02 (1.91) 4.33 (2.67 to 5.33) 0.00 8.00

CCBT + MCI 46 3.95 (2.05) 3.83 (2.00 to 5.67) 0.33 8.00

Pre-task ‘child in control’

Difference CCBT 40 0.16 (1.04) 0.33 (–0.42 to 0.92) –2.17 1.83

baseline–assessment 2
CCBT + MCBT 45 0.83 (1.55) 0.83 (0.17 to 1.50) –5.50 4.50

CCBT + MCI 46 0.78 (1.41) 1.00 (–0.17 to 1.67) –4.17 4.17

Score post treatment CCBT 40 6.93 (1.47) 7.08 (6.33 to 8.00) 3.17 10.00

CCBT + MCBT 45 7.32 (1.36) 7.50 (6.83 to 8.17) 3.00 9.50

CCBT + MCI 46 7.49 (1.22) 7.42 (7.00 to 8.50) 4.33 9.83

Total score baseline CCBT 40 6.77 (1.26) 6.83 (6.17 to 7.50) 4.00 9.33

CCBT + MCBT 45 6.49 (1.58) 6.33 (5.50 to 7.67) 2.17 9.17

CCBT + MCI 46 6.71 (1.13) 6.67 (5.83 to 7.50) 4.67 9.17

Pre-task ‘mother in control’

Difference CCBT 40 –0.18 (1.52) –0.17 (–1.08 to 0.58) –3.83 3.00

baseline–assessment 2
CCBT + MCBT 45 –0.19 (1.73) 0.00 (–1.50 to 0.67) –3.67 3.17
CCBT + MCI 46 –0.06 (1.92) 0.17 (–1.33 to 1.17) –4.00 3.67

Score post treatment CCBT 40 4.61 (1.60) 4.83 (3.33 to 5.58) 1.00 7.50

CCBT + MCBT 45 5.15 (2.48) 5.67 (2.83 to 7.17) 0.33 8.67

CCBT + MCI 46 4.91 (1.69) 5.21 (3.67 to 6.17) 0.83 8.33

Total score baseline CCBT 40 4.79 (1.65) 5.08 (3.75 to 6.00) 0.50 7.67

CCBT + MCBT 45 5.33 (1.96) 5.17 (4.00 to 6.83) 1.17 10.00

CCBT + MCI 46 4.98 (1.73) 5.25 (3.67 to 6.33) 1.25 7.83

IQR, interquartile range.

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
165
addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
Park, Southampton SO16 7NS, UK.
 APPENDIX 5

TABLE 126 Summary of child scores at baseline and assessment 2, and the change from baseline to assessment 2

Questionnaire Treatment n Mean (SD) Median (IQR) Minimum Maximum

SCAS-c

Difference CCBT 45 –19.5 (17.2) –17.0 (–29.0 to –8.0) –68 13

baseline–assessment 2
CCBT + MCBT 46 –15.0 (11.6) –16.0 (–23.0 to –8.0) –37 12

CCBT + MCI 52 –14.7 (20.0) –14.5 (–24.5 to –2.5) –72 20

Total score post CCBT 45 21.0 (15.3) 15.0 (11.0 to 30.0) 0 86

treatment
CCBT + MCBT 46 28.3 (15.2) 25.5 (16.0 to 41.0) 0 69
CCBT + MCI 52 24.9 (15.2) 23.0 (13.5 to 34.5) 0 65

Total score baseline CCBT 45 40.4 (21.7) 35.0 (24.0 to 53.0) 2 105

CCBT + MCBT 46 43.3 (17.6) 40.0 (31.0 to 58.0) 8 80

CCBT + MCI 52 39.6 (18.9) 40.0 (29.0 to 48.5) 4 92

CAIS-c

Difference CCBT 44 –7.0 (17.3) –8.0 (–17.0 to –1.0) –35 52

baseline–assessment 2
CCBT + MCBT 45 –8.4 (15.9) –7.0 (–11.0 to –2.0) –49 53
CCBT + MCI 53 –5.6 (15.9) –6.0 (–14.0 to 0.0) –48 70

Total score post CCBT 44 10.8 (12.2) 8.0 (3.0 to 13.0) 0 58

treatment
CCBT + MCBT 45 13.8 (13.2) 11.0 (4.0 to 21.0) 0 58

CCBT + MCI 53 12.4 (14.4) 8.0 (3.0 to 16.0) 0 78

Total score baseline CCBT 44 17.8 (12.5) 18.0 (8.5 to 24.5) 1 58

CCBT + MCBT 45 22.2 (15.9) 17.0 (10.0 to 32.0) 1 60

CCBT + MCI 53 18.1 (13.2) 15.0 (7.0 to 27.0) 0 63

SMFQ-c

Difference CCBT 46 –4.9 (6.0) –3.0 (–7.0 to –1.0) –20 2

baseline–assessment 2
CCBT + MCBT 47 –2.8 (4.7) –3.0 (–5.0 to –1.0) –12 12

CCBT + MCI 54 –2.3 (5.7) –2.0 (–5.0 to 1.0) –15 15

Total score post CCBT 46 2.7 (4.0) 1.5 (0.0 to 4.0) 0 23

treatment
CCBT + MCBT 47 6.0 (5.5) 4.0 (1.0 to 9.0) 0 24

CCBT + MCI 54 5.0 (5.7) 3.0 (0.0 to 8.0) 0 25

Total score baseline CCBT 46 7.6 (6.6) 5.0 (2.0 to 11.0) 0 24

CCBT + MCBT 47 8.8 (4.9) 8.0 (5.0 to 12.0) 0 22

CCBT + MCI 54 7.3 (5.6) 7.0 (3.0 to 11.0) 0 23

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 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

TABLE 126 Summary of child scores at baseline and assessment 2, and the change from baseline to
assessment 2 (continued )

Questionnaire Treatment n Mean (SD) Median (IQR) Minimum Maximum

SDQ-c conduct problems scale

Difference CCBT 47 –0.6 (1.6) –1.0 (–2.0 to 0.0) –4 1
baseline–assessment 2
CCBT + MCBT 47 –0.6 (2.0) 0.0 (–2.0 to 1.0) –5 3

CCBT + MCI 55 –0.5 (1.8) –1.0 (–1.0 to 0.0) –4 5

Total score post CCBT 47 2.2 (1.6) 2.0 (1.0 to 3.0) 0 8

treatment
CCBT + MCBT 47 2.4 (2.0) 2.0 (1.0 to 4.0) 0 8

CCBT + MCI 55 2.3 (2.0) 2.0 (0.0 to 3.0) 0 7

Total score baseline CCBT 47 2.8 (1.8) 3.0 (1.0 to 4.0) 0 7

CCBT + MCBT 47 3.0 (1.9) 3.0 (2.0 to 4.0) 0 8

CCBT + MCI 55 2.8 (1.6) 3.0 (2.0 to 4.0) 0 7

IQR, interquartile range.

TABLE 127 Summary of mothers’ questionnaire scores at baseline and assessment 2, and the change from baseline
to assessment 2

Questionnaire Treatment n Mean (SD) Median (IQR) Minimum Maximum

SCAS-p

Difference CCBT 36 –18.3 (10.9) –16.5 (–27.0 to –11.5) –36 12

baseline–assessment 2
CCBT + MCBT 39 –17.5 (12.2) –21.0 (–25.0 to –7.0) –38 10
CCBT + MCI 38 –17.3 (11.5) –16.0 (–24.0 to –9.0) –46 5

Total score post CCBT 36 23.8 (14.5) 20.0 (14.0 to 29.0) 3 80

treatment
CCBT + MCBT 39 26.0 (15.0) 24.0 (14.0 to 33.0) 2 62

CCBT + MCI 38 23.8 (8.7) 23.5 (19.0 to 28.0) 6 41

Total score baseline CCBT 36 42.0 (15.3) 41.5 (32.0 to 47.0) 16 94

CCBT + MCBT 39 43.5 (17.2) 38.0 (32.0 to 57.0) 17 82

CCBT + MCI 38 41.1 (13.3) 41.0 (30.0 to 50.0) 17 81

CAIS-p

Difference CCBT 33 –10.5 (8.9) –9.0 (–15.0 to –5.0) –34 5

baseline–assessment 2
CCBT + MCBT 35 –14.5 (10.5) –16.0 (–19.0 to –6.0) –45 2

CCBT + MCI 31 –8.1 (8.5) –8.0 (–14.0 to 0.0) –26 8

Total score post CCBT 33 12.6 (12.0) 8.0 (3.0 to 18.0) 0 48

treatment
CCBT + MCBT 35 11.2 (10.7) 9.0 (4.0 to 14.0) 0 38

CCBT + MCI 31 11.4 (8.2) 11.0 (4.0 to 15.0) 1 33

Total score baseline CCBT 33 23.1 (16.7) 18.0 (10.0 to 32.0) 1 66

CCBT + MCBT 35 25.7 (16.2) 25.0 (12.0 to 35.0) 0 60

CCBT + MCI 31 19.5 (11.9) 17.0 (10.0 to 28.0) 2 52

continued

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
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addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
Park, Southampton SO16 7NS, UK.
 APPENDIX 5

TABLE 127 Summary of mothers’ questionnaire scores at baseline and assessment 2, and the change from baseline
to assessment 2 (continued )

Questionnaire Treatment n Mean (SD) Median (IQR) Minimum Maximum

SMFQ-p
Difference CCBT 34 –4.1 (7.4) –4.0 (–6.0 to 0.0) –23 8
baseline–assessment 2
CCBT + MCBT 38 –6.8 (5.6) –6.0 (–10.0 to –3.0) –23 5

CCBT + MCI 35 –4.9 (6.6) –3.0 (–9.0 to 0.0) –23 5

Total score post CCBT 34 4.7 (5.1) 2.5 (1.0 to 8.0) 0 19

treatment
CCBT + MCBT 38 4.6 (5.7) 2.5 (0.0 to 6.0) 0 22

CCBT + MCI 35 3.9 (4.1) 2.0 (0.0 to 8.0) 0 14

Total score baseline CCBT 34 8.8 (7.3) 6.0 (4.0 to 14.0) 0 24

CCBT + MCBT 38 11.3 (7.7) 10.0 (5.0 to 16.0) 0 26

CCBT + MCI 35 8.9 (7.3) 7.0 (2.0 to 14.0) 0 23

SDQ-p conduct problems scale

Difference CCBT 37 –0.5 (1.6) –1.0 (–1.0 to 0.0) –6 3

baseline–assessment 2
CCBT + MCBT 41 –0.9 (1.3) –1.0 (–2.0 to 0.0) –4 3

CCBT + MCI 40 –0.9 (1.4) –1.0 (–1.0 to 0.0) –6 1

Total score post CCBT 37 1.7 (1.6) 1.0 (1.0 to 2.0) 0 8

treatment
CCBT + MCBT 41 1.9 (1.7) 2.0 (0.0 to 3.0) 0 6
CCBT + MCI 40 1.7 (1.8) 1.0 (0.0 to 2.5) 0 7

Total score baseline CCBT 37 2.2 (1.7) 2.0 (1.0 to 3.0) 0 8

CCBT + MCBT 41 2.8 (1.9) 3.0 (2.0 to 4.0) 0 9

CCBT + MCI 40 2.6 (2.0) 2.0 (1.0 to 4.0) 0 8

IQR, interquartile range.

168
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 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

TABLE 128 Summary of teachers’ questionnaire scores at baseline and assessment 2, and the change from baseline
to assessment 2

Questionnaire Treatment n Mean (SD) Median (IQR) Minimum Maximum

SCAS-t

Difference baseline–assessment 2 CCBT 7 –6.1 (9.4) –8.0 (–16.0 to 0.0) –18 8

CCBT + MCBT 14 –3.3 (12.1) –2.5 (–9.0 to 4.0) –34 21

CCBT + MCI 12 –6.0 (11.7) –5.0 (–7.0 to –0.5) –30 14

Total score post treatment CCBT 7 13.4 (11.5) 10.0 (7.0 to 25.0) 0 33

CCBT + MCBT 14 10.7 (9.4) 8.0 (7.0 to 10.0) 0 37

CCBT + MCI 12 12.4 (11.9) 9.0 (5.5 to 16.0) 1 46

Total score baseline CCBT 7 19.6 (19.5) 15.0 (2.0 to 43.0) 0 49

CCBT + MCBT 14 14.0 (12.2) 9.5 (5.0 to 16.0) 3 42

CCBT + MCI 12 18.4 (13.2) 11.5 (8.0 to 29.0) 4 40

CAS-t

Difference baseline–assessment 2 CCBT 18 –1.6 (3.8) –1.0 (–3.0 to 0.0) –11 5

CCBT + MCBT 24 –1.3 (4.6) –2.0 (–3.0 to 1.0) –16 8

CCBT + MCI 25 –1.4 (4.2) –2.0 (–4.0 to 2.0) –9 7

Total score post treatment CCBT 18 5.3 (4.3) 5.0 (2.0 to 8.0) 0 15

CCBT + MCBT 24 3.4 (2.9) 3.0 (0.5 to 6.0) 0 9

CCBT + MCI 25 3.8 (3.8) 3.0 (1.0 to 5.0) 0 16

Total score baseline CCBT 18 6.9 (5.2) 5.5 (3.0 to 10.0) 0 16

CCBT + MCBT 24 4.7 (4.2) 4.5 (1.0 to 6.0) 0 16

CCBT + MCI 25 5.1 (4.3) 5.0 (2.0 to 8.0) 0 14

SDQ-t conduct problems scale

Difference baseline–assessment 2 CCBT 18 0.4 (0.7) 0.0 (0.0 to 1.0) 0 2

CCBT + MCBT 22 –0.3 (1.5) 0.0 (–1.0 to 1.0) –4 3

CCBT + MCI 23 –0.1 (1.2) 0.0 (0.0 to 0.0) –3 3

Total score post treatment CCBT 18 1.2 (1.8) 0.5 (0.0 to 2.0) 0 7

CCBT + MCBT 22 1.1 (2.1) 0.0 (0.0 to 1.0) 0 8

CCBT + MCI 23 0.8 (1.7) 0.0 (0.0 to 1.0) 0 7

Total score baseline CCBT 18 0.7 (1.2) 0.0 (0.0 to 1.0) 0 5

CCBT + MCBT 22 1.4 (2.3) 0.5 (0.0 to 2.0) 0 10

CCBT + MCI 23 0.9 (1.7) 0.0 (0.0 to 1.0) 0 6

IQR, interquartile range.

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
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addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
Park, Southampton SO16 7NS, UK.
 APPENDIX 5

Questionnaires: assessment 2 – data summaries by treatment

arm (all available participants)

TABLE 129 Descriptive statistics: SCAS questionnaires post treatment

Questionnaire
subscale Treatment n n missing Mean (SD) Median (IQR) Minimum Maximum

SCAS-c total score CCBT 49 22 21.0 (15.6) 15.0 (10.0–30.0) 0 86

post treatment
CCBT + MCBT 47 22 29.1 (16.0) 26.0 (16.0–42.0) 0 69

CCBT + MCI 54 17 25.3 (15.5) 23.0 (14.0–35.0) 0 65

SCAS-p total score CCBT 40 31 23.3 (13.8) 20.0 (14.5–28.5) 3 80

post treatment
CCBT + MCBT 41 28 25.5 (14.8) 22.0 (14.0–32.0) 2 62
CCBT + MCI 40 31 23.9 (8.7) 23.5 (19.0–28.0) 6 41

SCAS-t total score CCBT 18 53 11.9 (10.3) 8.5 (5.0–16.0) 0 36

post treatment
CCBT + MCBT 22 47 12.2 (9.1) 9.0 (7.0–17.0) 0 37

CCBT + MCI 19 52 15.7 (12.8) 9.0 (7.0–20.0) 1 46

IQR, interquartile range.

TABLE 130 Descriptive statistics: CAIS questionnaires post treatment

Questionnaire
subscale Treatment n n missing Mean (SD) Median (IQR) Minimum Maximum

CAIS-c total score CCBT 49 22 10.9 (12.5) 8.0 (2.0–13.0) 0 58

post treatment
CCBT + MCBT 45 24 13.8 (13.2) 11.0 (4.0–21.0) 0 58
CCBT + MCI 56 15 12.5 (14.1) 9.5 (3.0–16.0) 0 78

CAIS-p total score CCBT 39 32 12.3 (11.3) 8.0 (4.0–19.0) 0 48

post treatment
CCBT + MCBT 42 27 12.5 (10.9) 10.0 (5.0–16.0) 0 38

CCBT + MCI 41 30 10.9 (8.2) 11.0 (4.0–15.0) 1 33

IQR, interquartile range.

170
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 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

TABLE 131 Descriptive statistics: SDQ and SMFQ questionnaires post treatment

Questionnaire
subscale Treatment n n missing Mean (SD) Median (IQR) Minimum Maximum

SDQ-c conduct CCBT 50 21 2.2 (1.6) 2.0 (1.0–3.0) 0 8

problems scale
post treatment CCBT + MCBT 48 21 2.4 (2.0) 2.0 (1.0–4.0) 0 8
CCBT + MCI 56 15 2.3 (2.0) 2.0 (0.5–3.0) 0 7

SDQ-p conduct CCBT 40 31 1.7 (1.6) 1.5 (0.5–2.0) 0 8

problems scale
post treatment CCBT + MCBT 44 25 2.0 (1.7) 2.0 (0.5–3.0) 0 6

CCBT + MCI 41 30 1.7 (1.8) 1.0 (0.0–2.0) 0 7

SDQ-t conduct CCBT 23 48 1.1 (1.7) 0.0 (0.0–2.0) 0 7

problems scale
post treatment CCBT + MCBT 27 42 1.0 (2.0) 0.0 (0.0–1.0) 0 8

CCBT + MCI 31 40 0.9 (1.6) 0.0 (0.0–2.0) 0 7

SMFQ-c total score CCBT 50 21 3.1 (4.4) 1.5 (0.0–5.0) 0 23
post treatment
CCBT + MCBT 48 21 6.3 (5.8) 4.0 (1.5–9.5) 0 24

CCBT + MCI 56 15 4.9 (5.6) 3.0 (0.0–8.0) 0 25

SMFQ-p total score CCBT 40 31 4.2 (4.9) 2.0 (0.0–6.5) 0 19

post treatment
CCBT + MCBT 43 26 5.3 (5.9) 3.0 (1.0–8.0) 0 22

CCBT + MCI 42 29 4.0 (4.5) 2.0 (0.0–7.0) 0 18

IQR, interquartile range.

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
171
addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
Park, Southampton SO16 7NS, UK.
 172
Missing data for different variables
APPENDIX 5

TABLE 132 Missing data by baseline demographics for different variables

At least one missing at assessment 2

Primary Child Parent Teacher

outcome questionnaires questionnaires questionnaires Behavioural Cognitions

Baseline characteristic Category n % n % n % n % n % n %

Gender Male 18 17.8 35 34.7 72 71.3 75 74.3 40 39.6 40 39.6

NIHR Journals Library www.journalslibrary.nihr.ac.uk

Female 16 14.5 29 26.4 72 65.5 81 73.6 35 31.8 38 34.5

Status Single, never married 6 50.0 7 58.3 10 83.3 10 83.3 6 50.0 7 58.3

Married (first time) 17 15.9 33 30.8 62 57.9 72 67.3 34 31.8 34 31.8

Remarried 3 18.8 3 18.8 6 37.5 12 75.0 4 25.0 4 25.0

Divorce/separated 5 11.4 9 20.5 41 93.2 34 77.3 16 36.4 18 40.9

Living with partner 3 10.7 11 39.3 21 75.0 25 89.3 15 53.6 15 53.6

Not recorded 0 0.0 1 25.0 4 100.0 3 75.0 0 0.0 0 0.0

Employment mother Unemployed 15 24.2 20 32.3 43 69.4 48 77.4 26 41.9 29 46.8

Part time 14 13.6 31 30.1 71 68.9 77 74.8 38 36.9 38 36.9

Full time 5 14.3 9 25.7 22 62.9 22 62.9 8 22.9 8 22.9

Not recorded 0 0.0 4 36.4 8 72.7 9 81.8 3 27.3 3 27.3

Employment father Unemployed 3 25.0 4 33.3 8 66.7 8 66.7 3 25.0 3 25.0

Part time 0 0.0 0 0.0 1 50.0 2 100.0 0 0.0 0 0.0

Full time 25 16.3 49 32.0 94 61.4 112 73.2 55 35.9 55 35.9

NA 3 42.9 4 57.1 7 100.0 5 71.4 4 57.1 4 57.1

Not recorded 3 8.1 7 18.9 34 91.9 29 78.4 13 35.1 16 43.2

 TABLE 132 Missing data by baseline demographics for different variables (continued )

At least one missing at assessment 2

Primary Child Parent Teacher

outcome questionnaires questionnaires questionnaires Behavioural Cognitions

Baseline characteristic Category n % n % n % n % n % n %

Park, Southampton SO16 7NS, UK.

DOI: 10.3310/hta19380

Overall SES Higher professional 13 12.3 28 26.4 63 59.4 75 70.8 34 32.1 34 32.1

Other employed 14 19.7 24 33.8 53 74.6 54 76.1 26 36.6 26 36.6

Unemployed 0 0.0 0 0.0 3 100.0 2 66.7 0 0.0 1 33.3

Not recorded 7 22.6 12 38.7 25 80.6 25 80.6 15 48.4 17 54.8

ADIS-C/P primary diagnosis SAD 1 2.4 6 14.6 21 51.2 24 58.5 10 24.4 10 24.4

Social phobia 11 19.6 18 32.1 37 66.1 44 78.6 22 39.3 22 39.3

GAD 7 14.6 17 35.4 32 66.7 35 72.9 15 31.3 17 35.4

Other 15 22.7 23 34.8 54 81.8 53 80.3 28 42.4 29 43.9

ADIS-C/P primary diagnosis CSR Moderate 4 4 25.0 9 56.3 14 87.5 13 81.3 9 56.3 9 56.3
(initial assessment)
Moderate 5 9 15.3 14 23.7 40 67.8 36 61.0 18 30.5 18 30.5

Severe 6 16 14.2 35 31.0 74 65.5 88 77.9 37 32.7 39 34.5

Severe 7 5 21.7 6 26.1 16 69.6 19 82.6 11 47.8 12 52.2

ADIS-C/P primary diagnosis CSR No diagnosis 0 0.0 2 66.7 2 66.7 2 66.7 2 66.7 2 66.7
at assessment 1B
Mild 3 0 0.0 2 33.3 4 66.7 4 66.7 2 33.3 2 33.3

Moderate 4 2 7.4 10 37.0 18 66.7 21 77.8 7 25.9 7 25.9

Moderate 5 9 14.8 14 23.0 40 65.6 42 68.9 21 34.4 23 37.7

Severe 6 8 8.5 21 22.3 63 67.0 69 73.4 29 30.9 30 31.9

Severe 7 2 33.3 2 33.3 4 66.7 4 66.7 2 33.3 2 33.3

Very severe 8 0 0.0 0 0.0 0 0.0 1 100.0 0 0.0 0 0.0

Not recorded 13 100.0 13 100.0 13 100.0 13 100.0 12 92.3 12 92.3

provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
continued

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addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

173
 174
APPENDIX 5

TABLE 132 Missing data by baseline demographics for different variables (continued )

At least one missing at assessment 2

NIHR Journals Library www.journalslibrary.nihr.ac.uk

Primary Child Parent Teacher
outcome questionnaires questionnaires questionnaires Behavioural Cognitions

Baseline characteristic Category n % n % n % n % n % n %

Child age (years) 6 1 100.0 1 100.0 1 100.0 1 100.0 1 100.0 1 100.0

7 5 31.3 7 43.8 11 68.8 13 81.3 8 50.0 9 56.3

8 5 15.6 10 31.3 19 59.4 19 59.4 10 31.3 10 31.3

9 5 15.2 11 33.3 17 51.5 24 72.7 10 30.3 10 30.3

10 6 12.8 16 34.0 38 80.9 35 74.5 15 31.9 16 34.0

11 4 8.5 7 14.9 29 61.7 35 74.5 14 29.8 14 29.8

12 8 25.0 12 37.5 27 84.4 26 81.3 16 50.0 17 53.1

13 0 0.0 0 0.0 2 66.7 3 100.0 1 33.3 1 33.3
NA, not applicable.
 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

Questionnaire baseline results by treatment arm (all available

participants)

TABLE 133 Descriptive statistics: SCAS questionnaires baseline

Questionnaire
subscale Treatment n n missing Mean (SD) Median (IQR) Minimum Maximum

SCAS-c total score CCBT 67 4 40.2 (21.3) 35.0 (24.0–53.0) 2 105

post baseline
CCBT + MCBT 67 2 41.3 (18.3) 41.0 (29.0–56.0) 7 80

CCBT + MCI 69 2 39.2 (17.4) 39.0 (29.0–47.0) 4 92

SCAS-p total CCBT 64 7 43.2 (15.6) 43.0 (32.5–50.0) 16 94

score baseline
CCBT + MCBT 63 6 42.2 (15.5) 39.0 (32.0–50.0) 17 82
CCBT + MCI 65 6 41.6 (16.7) 40.0 (29.0–52.0) 16 94

SCAS-t total CCBT 25 46 17.6 (13.4) 15.0 (10.0–22.0) 0 49

score baseline
CCBT + MCBT 37 32 14.4 (14.6) 9.0 (5.0–16.0) 1 66

CCBT + MCI 42 29 18.7 (13.0) 15.0 (10.0–26.0) 0 47

IQR, interquartile range.

TABLE 134 Descriptive statistics: CAIS questionnaires baseline

Questionnaire
subscale Treatment n n missing Mean (SD) Median (IQR) Minimum Maximum

CAIS-c total CCBT 66 5 18.3 (12.8) 16.5 (9.0–24.0) 1 58

score baseline
CCBT + MCBT 67 2 23.1 (16.3) 20.0 (10.0–37.0) 0 70
CCBT + MCI 68 3 18.9 (14.0) 15.0 (7.5–28.0) 0 63

CAIS-p total CCBT 58 13 23.2 (16.0) 18.5 (11.0–32.0) 1 66

score baseline
CCBT + MCBT 56 13 25.5 (15.1) 25.0 (15.0–34.5) 0 60

CCBT + MCI 58 13 20.6 (12.7) 17.0 (10.0–28.0) 1 58

IQR, interquartile range.

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
175
addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
Park, Southampton SO16 7NS, UK.
 APPENDIX 5

TABLE 135 Descriptive statistics: SDQ and SMFQ baseline

Questionnaire
subscale Treatment n n missing Mean (SD) Median (IQR) Minimum Maximum

SDQ-c conduct CCBT 68 3 3.0 (2.0) 3.0 (1.0–4.0) 0 8

problems
scale baseline CCBT + MCBT 66 3 3.0 (1.9) 3.0 (2.0–4.0) 0 8
CCBT + MCI 70 1 2.8 (1.7) 3.0 (2.0–4.0) 0 8

SDQ-p conduct CCBT 65 6 2.5 (2.0) 2.0 (1.0–3.0) 0 8

problems
scale baseline CCBT + MCBT 65 4 3.0 (1.8) 3.0 (2.0–4.0) 0 9

CCBT + MCI 70 1 2.6 (1.9) 2.0 (1.0–4.0) 0 8

SDQ-t conduct CCBT 44 27 0.9 (1.5) 0.0 (0.0–1.0) 0 6

problems
scale baseline CCBT + MCBT 54 15 1.2 (1.9) 0.0 (0.0–2.0) 0 10

CCBT + MCI 56 15 1.8 (1.5) 0.0 (0.0–1.0) 0 6

SMFQ-c total CCBT 67 4 7.8 (6.8) 5.0 (2.0–13.0) 0 24
score baseline
CCBT + MCBT 68 1 9.0 (5.5) 8.5 (5.0–12.0) 0 24

CCBT + MCI 69 2 7.4 (5.7) 6.0 (3.0–10.0) 0 23

SMFQ-p report total CCBT 59 12 9.4 (6.6) 7.0 (4.0–14.0) 0 24

score baseline
CCBT + MCBT 58 11 10.7 (7.2) 10.0 (5.0–15.0) 0 26

CCBT + MCI 62 9 8.8 (7.2) 7.0 (3.0–14.0) 0 25

IQR, interquartile range.

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 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

Summary of questionnaire scores at different time points by

treatment arm

TABLE 136 Summary of child-reported questionnaire scores at baseline, 6 months, and change from baseline to
6 months

Questionnaire Treatment n Mean (SD) Median (IQR) Minimum Maximum

CAIS-c

Total score difference CCBT 38 –10.87 (13.07) –11.0 (–20.0 to 1.0) –37 15
baseline–6 months
CCBT + MCBT 43 –13.86 (15.74) –11.0 (–21.0 to –5.0) –62 13

CCBT + MCI 41 –9.56 (13.48) –9.0 (–17.0 to 0.0) –47 13

Total score 6 months CCBT 38 7.37 (7.01) 5.5 (2.0 to 11.0) 0 27

CCBT + MCBT 43 10.02 (8.56) 8.0 (3.0 to 14.0) 0 29

CCBT + MCI 41 9.63 (9.35) 7.0 (2.0 to 15.0) 0 39

Total score baseline CCBT 38 18.24 (13.10) 18.0 (9.0 to 25.0) 1 58

CCBT + MCBT 43 23.88 (16.41) 21.0 (11.0 to 37.0) 1 70

CCBT + MCI 41 19.20 (13.44) 18.0 (8.0 to 27.0) 0 63

SCAS-c

Total score difference CCBT 41 –17.80 (17.91) –15.0 (–28.0 to –6.0) –61 13
baseline–6 months
CCBT + MCBT 43 –17.47 (16.35) –18.0 (–26.0 to –6.0) –51 29

CCBT + MCI 41 –16.83 (21.80) –13.0 (–28.0 to –5.0) –70 22

Total score 6 months CCBT 41 22.20 (16.22) 19.0 (10.0 to 30.0) 0 73

CCBT + MCBT 43 24.42 (17.41) 19.0 (12.0 to 39.0) 0 63

CCBT + MCI 41 23.73 (17.51) 22.0 (9.0 to 30.0) 1 67

Total score baseline CCBT 41 40.00 (21.60) 35.0 (24.0 to 53.0) 2 105

CCBT + MCBT 43 41.88 (16.63) 39.0 (31.0 to 54.0) 10 80

CCBT + MCI 41 40.56 (18.60) 42.0 (30.0 to 48.0) 11 92

SDQ-c conduct subscale

Total score difference CCBT 42 –0.86 (1.76) –1.0 (–2.0 to 0.0) –4 3

baseline–6 months
CCBT + MCBT 44 –0.89 (2.08) –1.0 (–2.0 to 1.0) –6 3

CCBT + MCI 42 –0.86 (1.47) –1.0 (–2.0 to 0.0) –4 2

Total score 6 months CCBT 42 2.10 (1.64) 2.0 (1.0 to 3.0) 0 6

CCBT + MCBT 44 2.05 (1.38) 2.0 (1.0 to 3.0) 0 6

CCBT + MCI 42 2.17 (1.95) 2.0 (1.0 to 3.0) 0 6

Total score baseline CCBT 42 2.95 (1.82) 3.0 (1.0 to 4.0) 0 8

CCBT + MCBT 44 2.93 (1.90) 3.0 (1.5 to 4.5) 0 8

CCBT + MCI 42 3.02 (1.79) 3.0 (2.0 to 4.0) 0 8

continued

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
177
addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
Park, Southampton SO16 7NS, UK.
 APPENDIX 5

TABLE 136 Summary of child-reported questionnaire scores at baseline, 6 months, and change from baseline to
6 months (continued )

Questionnaire Treatment n Mean (SD) Median (IQR) Minimum Maximum

SMFQ-c
Total score difference CCBT 40 –3.45 (6.49) –2.0 (–5.5 to 1.0) –23 7
baseline–6 months
CCBT + MCBT 44 –4.25 (6.03) –3.0 (–6.0 to –0.5) –24 7

CCBT + MCI 39 –3.51 (6.12) –4.0 (–7.0 to 0.0) –20 15

Total score 6 months CCBT 40 4.18 (5.01) 3.0 (0.0 to 6.0) 0 19

CCBT + MCBT 44 5.20 (4.99) 4.5 (0.5 to 10.0) 0 16

CCBT + MCI 39 4.03 (5.24) 1.0 (0.0 to 8.0) 0 22

Total score baseline CCBT 40 7.63 (6.93) 5.0 (2.5 to 11.5) 0 24

CCBT + MCBT 44 9.45 (5.94) 8.5 (5.0 to 13.0) 0 24

CCBT + MCI 39 7.54 (5.88) 5.0 (3.0 to 11.0) 0 23

IQR, interquartile range.

TABLE 137 Summary of mother- and child-reported questionnaire scores at baseline, 6 months, and change from
baseline to 6 months

Questionnaire Treatment n Mean (SD) Median (IQR) Minimum Maximum

CAIS-c/p

Total score difference CCBT 35 –9.40 (10.26) –7.0 (–17.0 to –1.0) –33 8
baseline–6 months
CCBT + MCBT 37 –13.78 (13.07) –12.0 (–21.0 to –4.0) –47 4

CCBT + MCI 34 –8.47 (10.71) –9.0 (–14.0 to 0.0) –29 11

Total score 6 months CCBT 35 13.51 (13.24) 9.0 (3.0 to 22.0) 0 54

CCBT + MCBT 37 11.46 (10.00) 9.0 (5.0 to 16.0) 1 44

CCBT + MCI 34 11.24 (9.24) 9.0 (5.0 to 17.0) 0 38

Total score baseline CCBT 35 22.91 (15.48) 20.0 (11.0 to 30.0) 1 66

CCBT + MCBT 37 25.24 (16.00) 25.0 (12.0 to 35.0) 0 60

CCBT + MCI 34 19.71 (11.13) 17.0 (11.0 to 26.0) 2 52

SCAS-c/p
Total score difference CCBT 36 –17.81 (11.43) –19.0 (–25.5 to –11.5) –44 3
baseline–6 months
CCBT + MCBT 41 –17.32 (12.64) –18.0 (–24.0 to –10.0) –45 13

CCBT + MCI 38 –18.29 (13.59) –16.0 (–27.0 to –9.0) –44 15

Total score 6 months CCBT 36 23.11 (16.89) 20.0 (14.0 to 28.5) 1 93

CCBT + MCBT 41 23.66 (13.68) 20.0 (14.0 to 31.0) 3 61

CCBT + MCI 38 22.68 (11.01) 22.0 (15.0 to 28.0) 5 51

Total score baseline CCBT 36 40.92 (14.95) 39.0 (31.0 to 46.0) 20 94

CCBT + MCBT 41 40.98 (15.15) 38.0 (32.0 to 49.0) 17 82

CCBT + MCI 38 40.97 (14.64) 41.0 (29.0 to 52.0) 16 81

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 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

TABLE 137 Summary of mother- and child-reported questionnaire scores at baseline, 6 months, and change from
baseline to 6 months (continued )

Questionnaire Treatment n Mean (SD) Median (IQR) Minimum Maximum

SDQ-c/p conduct subscale

Total score difference CCBT 39 –0.36 (1.50) 0.0 (–1.0 to 0.0) –5 3
baseline–6 months
CCBT + MCBT 42 –1.12 (1.21) –1.0 (–2.0 to 0.0) –4 2

CCBT + MCI 41 –1.12 (1.50) –1.0 (–2.0 to 0.0) –4 1

Total score 6 months CCBT 39 2.05 (1.92) 2.0 (1.0 to 3.0) 0 8

CCBT + MCBT 42 1.79 (1.63) 1.0 (1.0 to 3.0) 0 6

CCBT + MCI 41 1.44 (1.42) 1.0 (0.0 to 2.0) 0 6

Total score baseline CCBT 39 2.41 (1.98) 2.0 (1.0 to 3.0) 0 8

CCBT + MCBT 42 2.90 (1.69) 3.0 (2.0 to 4.0) 0 9

CCBT + MCI 41 2.56 (1.90) 2.0 (1.0 to 4.0) 0 8

SMFQ-c/p

Total score difference CCBT 36 –3.56 (6.53) –2.5 (–5.5 to 1.0) –21 10
baseline–6 months
CCBT + MCBT 38 –6.76 (6.66) –6.0 (–9.0 to –2.0) –25 3

CCBT + MCI 36 –4.64 (6.33) –3.0 (–9.0 to –0.5) –19 8

Total score 6 months CCBT 36 5.31 (5.95) 3.0 (0.5 to 9.0) 0 25

CCBT + MCBT 38 4.61 (5.53) 2.0 (0.0 to 6.0) 0 20

CCBT + MCI 36 4.56 (4.87) 4.0 (1.0 to 7.5) 0 23

Total score baseline CCBT 36 8.86 (6.86) 6.0 (4.0 to 13.0) 0 24

CCBT + MCBT 38 11.37 (7.72) 10.0 (6.0 to 17.0) 0 26

CCBT + MCI 36 9.19 (6.86) 8.5 (2.5 to 14.0) 0 23

IQR, interquartile range.

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
179
addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
Park, Southampton SO16 7NS, UK.
 APPENDIX 5

TABLE 138 Summary of teacher-reported questionnaire scores at baseline, 6 months, and change from baseline
to 6 months

Questionnaire Treatment n Mean (SD) Median (IQR) Minimum Maximum

CAS-t

Total score difference CCBT 11 –2.55 (5.82) –1.0 (–9.0 to 1.0) –13 5
baseline–6 months
CCBT + MCBT 17 –2.35 (5.15) –2.0 (–5.0 to 2.0) –16 5
CCBT + MCI 23 –1.30 (3.94) 0.0 (–5.0 to 1.0) –9 5

Total score 6 months CCBT 11 4.82 (5.08) 2.0 (0.0 to 8.0) 0 14

CCBT + MCBT 17 3.35 (3.32) 2.0 (1.0 to 5.0) 0 10

CCBT + MCI 23 4.74 (4.54) 4.0 (1.0 to 8.0) 0 16

Total score baseline CCBT 11 7.36 (5.26) 6.0 (3.0 to 13.0) 0 16

CCBT + MCBT 17 5.71 (5.58) 6.0 (0.0 to 10.0) 0 16

CCBT + MCI 23 6.04 (4.72) 7.0 (1.0 to 9.0) 0 16

SCAS-t

Total score difference CCBT 4 –1.25 (4.99) –0.5 (–4.5 to 2.0) –8 4

baseline–6 months
CCBT + MCBT 9 –12.22 (12.28) –9.0 (–13.0 to –8.0) –37 4

CCBT + MCI 15 –11.73 (11.63) –9.0 (–24.0 to –3.0) –36 1

Total score 6 months CCBT 4 15.75 (19.05) 10.0 (3.0 to 28.5) 0 43

CCBT + MCBT 9 5.56 (4.07) 4.0 (3.0 to 7.0) 2 15

CCBT + MCI 15 10.73 (9.04) 7.0 (4.0 to 16.0) 0 31

Total score baseline CCBT 4 17.00 (16.19) 14.5 (7.0 to 27.0) 0 39

CCBT + MCBT 9 17.78 (13.23) 16.0 (12.0 to 17.0) 3 40

CCBT + MCI 15 22.47 (13.08) 20.0 (10.0 to 36.0) 6 44

SDQ-t conduct subscale

Total score difference CCBT 12 0.58 (2.11) 0.0 (0.0 to 0.5) –1 7

baseline–6 months
CCBT + MCBT 18 –0.06 (1.70) 0.0 (0.0 to 0.0) –2 6

CCBT + MCI 22 0.41 (1.37) 0.0 (0.0 to 0.0) –1 5

Total score 6 months CCBT 12 1.25 (2.18) 0.0 (0.0 to 1.5) 0 7

CCBT + MCBT 18 0.61 (1.54) 0.0 (0.0 to 0.0) 0 6

CCBT + MCI 22 0.86 (1.70) 0.0 (0.0 to 1.0) 0 5

Total score baseline CCBT 12 0.67 (1.44) 0.0 (0.0 to 1.0) 0 5

CCBT + MCBT 18 0.67 (1.08) 0.0 (0.0 to 1.0) 0 3

CCBT + MCI 22 0.45 (1.14) 0.0 (0.0 to 0.0) 0 5

IQR, interquartile range.

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 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

TABLE 139 Summary of child-reported questionnaire scores at baseline, 12 months, and change from baseline to
12 months

Questionnaire Treatment n Mean (SD) Median (IQR) Minimum Maximum

CAIS-c

Total score difference CCBT 29 –8.41 (12.18) –6.0 (–15.0 to 0.0) –34 16
baseline–12 months
CCBT + MCBT 33 –15.24 (23.01) –14.0 (–29.0 to –6.0) –51 77
CCBT + MCI 37 –9.86 (10.88) –8.0 (–19.0 to –1.0) –36 13

Total score 12 months CCBT 29 6.38 (6.30) 4.0 (1.0 to 10.0) 0 25

CCBT + MCBT 33 11.82 (15.16) 7.0 (2.0 to 18.0) 0 78

CCBT + MCI 37 8.00 (11.33) 4.0 (1.0 to 10.0) 0 49

Total score baseline CCBT 29 14.79 (11.48) 14.0 (3.0 to 22.0) 1 40

CCBT + MCBT 33 27.06 (17.26) 22.0 (14.0 to 41.0) 1 60

CCBT + MCI 37 17.86 (14.00) 15.0 (6.0 to 26.0) 0 63

SCAS-c

Total score difference CCBT 31 –14.68 (17.11) –12.0 (–25.0 to 0.0) –52 21
baseline–12 months
CCBT + MCBT 34 –21.44 (15.86) –22.5 (–27.0 to –13.0) –59 12

CCBT + MCI 37 –17.78 (19.53) –20.0 (–28.0 to –4.0) –58 22

Total score 12 months CCBT 31 18.94 (13.34) 18.0 (9.0 to 29.0) 1 54

CCBT + MCBT 34 23.09 (14.92) 21.0 (10.0 to 34.0) 0 52

CCBT + MCI 37 20.78 (19.04) 13.0 (9.0 to 33.0) 0 68

Total score baseline CCBT 31 33.61 (18.20) 30.0 (22.0 to 45.0) 2 88

CCBT + MCBT 34 44.53 (17.52) 42.5 (31.0 to 59.0) 10 80

CCBT + MCI 37 38.57 (19.17) 41.0 (29.0 to 47.0) 4 92

SDQ-c conduct subscale

Total score difference CCBT 31 –1.06 (1.73) –1.0 (–2.0 to 0.0) –5 3

baseline–12 months
CCBT + MCBT 34 –0.97 (2.12) –1.0 (–2.0 to 0.0) –7 3

CCBT + MCI 38 –1.08 (2.50) –1.0 (–2.0 to 0.0) –8 8

Total score 12 months CCBT 31 1.65 (1.52) 2.0 (0.0 to 3.0) 0 5

CCBT + MCBT 34 2.03 (1.68) 2.0 (1.0 to 2.0) 0 8

CCBT + MCI 38 1.97 (2.33) 1.0 (0.0 to 3.0) 0 8

Total score baseline CCBT 31 2.71 (1.81) 3.0 (1.0 to 4.0) 0 7

CCBT + MCBT 34 3.00 (2.09) 3.0 (1.0 to 4.0) 0 8

CCBT + MCI 38 3.05 (1.84) 3.0 (2.0 to 4.0) 0 8

SMFQ-c
Total score difference CCBT 28 –2.89 (6.11) –2.0 (–5.0 to 1.0) –24 5
baseline–12 months
CCBT + MCBT 35 –5.51 (5.73) –6.0 (–11.0 to –2.0) –13 9

CCBT + MCI 37 –1.95 (5.68) –2.0 (–5.0 to 1.0) –20 12

Total score 12 months CCBT 28 2.86 (3.67) 1.0 (0.0 to 5.0) 0 12

CCBT + MCBT 35 4.31 (5.42) 3.0 (0.0 to 6.0) 0 25

CCBT + MCI 37 4.73 (6.78) 1.0 (0.0 to 6.0) 0 26

continued

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
181
addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
Park, Southampton SO16 7NS, UK.
 APPENDIX 5

TABLE 139 Summary of child-reported questionnaire scores at baseline, 12 months, and change from baseline to
12 months (continued )

Questionnaire Treatment n Mean (SD) Median (IQR) Minimum Maximum

Total score baseline CCBT 28 5.75 (5.69) 4.5 (1.5 to 8.0) 0 24

CCBT + MCBT 35 9.83 (5.39) 11.0 (5.0 to 14.0) 0 22

CCBT + MCI 37 6.68 (5.47) 5.0 (3.0 to 9.0) 0 23

IQR, interquartile range.

TABLE 140 Summary of mother- and child-reported questionnaire scores at baseline, 12 months, and change from
baseline to 12 months

Questionnaire Treatment n Mean (SD) Median (IQR) Minimum Maximum

CAIS-c/p

Total score difference CCBT 28 –9.32 (10.99) –7.5 (–15.5 to –1.0) –37 6
baseline–12 months
CCBT + MCBT 27 –15.07 (11.07) –16.0 (–22.0 to –5.0) –37 2

CCBT + MCI 31 –9.90 (10.31) –8.0 (–16.0 to –1.0) –39 5

Total score 12 months CCBT 28 11.57 (12.64) 8.0 (3.5 to 15.5) 0 58

CCBT + MCBT 27 12.74 (11.72) 8.0 (4.0 to 17.0) 0 42

CCBT + MCI 31 8.03 (6.79) 7.0 (1.0 to 13.0) 0 24

Total score baseline CCBT 28 20.89 (15.12) 17.0 (10.5 to 26.5) 1 66

CCBT + MCBT 27 27.81 (16.82) 25.0 (16.0 to 44.0) 0 60

CCBT + MCI 31 17.94 (11.52) 15.0 (10.0 to 24.0) 1 52

SCAS-c/p
Total score difference CCBT 30 –21.97 (13.18) –23.5 (–31.0 to –11.0) –48 3
baseline–12 months
CCBT + MCBT 31 –16.26 (14.23) –15.0 (–26.0 to –6.0) –43 12

CCBT + MCI 33 –20.85 (15.57) –19.0 (–29.0 to –12.0) –59 6

Total score 12 months CCBT 30 18.67 (13.68) 14.0 (9.0 to 29.0) 1 51

CCBT + MCBT 31 24.90 (15.55) 25.0 (12.0 to 33.0) 1 66

CCBT + MCI 33 19.12 (12.99) 17.0 (13.0 to 24.0) 2 58

Total score baseline CCBT 30 40.63 (14.09) 39.5 (32.0 to 46.0) 16 74

CCBT + MCBT 31 41.16 (17.02) 37.0 (29.0 to 55.0) 17 75

CCBT + MCI 33 39.97 (14.44) 42.0 (29.0 to 50.0) 16 81

SDQ-c/p conduct subscale

Total score difference CCBT 32 –0.75 (1.74) 0.0 (–2.0 to 0.0) –6 2

baseline–12 months
CCBT + MCBT 32 –1.13 (1.50) –1.0 (–2.0 to 0.0) –4 1

CCBT + MCI 38 –0.95 (1.66) –1.0 (–2.0 to 0.0) –4 3

Total score 12 months CCBT 32 1.25 (1.65) 1.0 (0.0 to 2.0) 0 8

CCBT + MCBT 32 1.91 (1.47) 2.0 (0.5 to 3.0) 0 5

CCBT + MCI 38 1.82 (2.04) 1.0 (0.0 to 3.0) 0 8

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 DOI: 10.3310/hta19380 HEALTH TECHNOLOGY ASSESSMENT 2015 VOL. 19 NO. 38

TABLE 140 Summary of mother- and child-reported questionnaire scores at baseline, 12 months, and change from
baseline to 12 months (continued )

Questionnaire Treatment n Mean (SD) Median (IQR) Minimum Maximum

Total score baseline CCBT 32 2.00 (1.95) 2.0 (1.0 to 3.0) 0 8

CCBT + MCBT 32 3.03 (1.82) 3.0 (2.0 to 4.0) 0 7

CCBT + MCI 38 2.76 (2.03) 2.0 (1.0 to 4.0) 0 8

SMFQ-c/p

Total score difference CCBT 30 –4.00 (6.37) –3.0 (–5.0 to –1.0) –24 8
baseline–12 months
CCBT + MCBT 29 –6.31 (6.20) –5.0 (–9.0 to –1.0) –24 4

CCBT + MCI 33 –5.64 (6.95) –3.0 (–10.0 to –1.0) –22 4

Total score 12 months CCBT 30 4.10 (5.36) 2.0 (0.0 to 6.0) 0 20

CCBT + MCBT 29 6.21 (6.04) 5.0 (1.0 to 9.0) 0 22

CCBT + MCI 33 3.45 (4.83) 1.0 (0.0 to 5.0) 0 18

Total score baseline CCBT 30 8.10 (6.72) 5.5 (4.0 to 9.0) 1 24

CCBT + MCBT 29 12.52 (8.17) 12.0 (7.0 to 19.0) 0 26

CCBT + MCI 33 9.09 (7.15) 8.0 (2.0 to 14.0) 0 23

IQR, interquartile range.

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Creswell et al. under the terms of a commissioning contract issued by the Secretary of State for
Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals
provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be
183
addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
Park, Southampton SO16 7NS, UK.
 APPENDIX 5

TABLE 141 Summary of teacher-reported questionnaire scores at baseline, 12 months, and change from baseline to
12 months

Questionnaire Treatment n Mean (SD) Median (IQR) Minimum Maximum

CAS-t

Total score difference CCBT 9 –2.22 (4.99) –1.0 (–3.0 to 2.0) –11 3
baseline–12 months
CCBT + MCBT 10 0.40 (4.14) –0.5 (–3.0 to 2.0) –4 8
CCBT + MCI 12 –1.75 (4.05) –2.0 (–5.0 to 1.5) –7 5

Total score 12 months CCBT 9 5.00 (4.92) 2.0 (2.0 to 8.0) 0 14

CCBT + MCBT 10 4.60 (3.41) 4.5 (2.0 to 7.0) 0 10

CCBT + MCI 12 5.25 (2.93) 6.0 (3.5 to 7.5) 0 9

Total score baseline CCBT 9 7.22 (3.63) 6.0 (5.0 to 10.0) 3 13

CCBT + MCBT 10 4.20 (2.90) 3.5 (3.0 to 6.0) 0 10

CCBT + MCI 12 7.00 (4.29) 6.5 (4.5 to 10.0) 1 16

SCAS-t

Total score difference CCBT 4 –8.25 (3.77) –8.0 (–11.0 to –5.5) –13 –4
baseline–12 months
CCBT + MCBT 4 4.25 (23.13) 2.0 (–12.5 to 21.0) –21 34

CCBT + MCI 5 –13.20 (16.30) –15.0 (–20.0 to 2.0) –36 3

Total score 12 months CCBT 4 13.00 (12.70) 7.0 (6.0 to 20.0) 6 32

CCBT + MCBT 4 22.00 (11.92) 18.5 (14.0 to 30.0) 12 39

CCBT + MCI 5 8.80 (3.90) 10.0 (7.0 to 11.0) 3 13

Total score baseline CCBT 4 21.25 (12.66) 18.0 (12.5 to 30.0) 10 39

CCBT + MCBT 4 17.75 (16.82) 12.0 (6.5 to 29.0) 5 42

CCBT + MCI 5 22.00 (14.25) 25.0 (10.0 to 31.0) 5 39

SDQ-t conduct subscale

Total score difference CCBT 9 –0.11 (1.17) 0.0 (–1.0 to 0.0) –2 2

baseline–12 months
CCBT + MCBT 11 –0.27 (1.49) 0.0 (–1.0 to 0.0) –4 2

CCBT + MCI 12 0.58 (1.62) 0.0 (–0.5 to 1.5) –1 4

Total score 12 months CCBT 9 1.22 (1.92) 0.0 (0.0 to 1.0) 0 5

CCBT + MCBT 11 0.36 (0.67) 0.0 (0.0 to 1.0) 0 2

CCBT + MCI 12 1.33 (1.78) 0.5 (0.0 to 2.5) 0 5

Total score baseline CCBT 9 1.33 (1.58) 1.0 (0.0 to 2.0) 0 5

CCBT + MCBT 11 0.64 (1.29) 0.0 (0.0 to 1.0) 0 4

CCBT + MCI 12 0.75 (1.48) 0.0 (0.0 to 1.0) 0 5

IQR, interquartile range.

184
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