ARTICLES
Randomized, Controlled Trial of an Intervention for
Toddlers With Autism: The Early Start Denver Model
AUTHORS: Geraldine Dawson, PhD,a,b,c Sally Rogers,                       WHAT’S KNOWN ON THIS SUBJECT: Previous studies on the
PhD,d Jeffrey Munson, PhD,e,f Milani Smith, PhD,e Jamie                  efficacy of early behavioral intervention for improving outcomes
Winter, PhD,e Jessica Greenson, PhD,e Amy Donaldson,                     for preschool-aged children with autism have yielded promising
PhD,g and Jennifer Varley, MSe                                           results. However, no randomized clinical trials of early
aAutism Speaks; bDepartment of Psychiatry, University of North
                                                                         developmental behavioral intervention designed for toddlers with
Carolina, Chapel Hill, North Carolina; cDepartment of Psychology,
eUniversity of Washington Autism Center, Center on Human
                                                                         autism have been conducted to date.
Development and Disability, and fDepartment of Psychiatry and
Behavioral Sciences, University of Washington, Seattle,                  WHAT THIS STUDY ADDS: This study assessed the efficacy of the
Washington; dMIND Institute, Department of Psychiatry,                   Early Start Denver Model, a comprehensive developmental
University of California Davis, Sacramento, California; and              behavioral intervention, for improving outcomes of toddlers with
gDepartment of Speech and Hearing Science, Portland State
                                                                         ASD. The intervention, which was initiated when children were
University, Portland, Oregon
                                                                         less than 21⁄2 years, resulted in significant improvements in IQ,
KEY WORDS                                                                language, adaptive behavior, and autism diagnosis.
autism, behavioral intervention, cognitive function,
developmental outcomes, early intervention
ABBREVIATIONS
ASD—autism spectrum disorder
ESDM—Early Start Denver Model
ABA—applied behavior analysis
A/M—assess and monitor
                                                                    abstract
PDD—pervasive developmental disorder                                OBJECTIVE: To conduct a randomized, controlled trial to evaluate the
NOS—not otherwise specified                                          efficacy of the Early Start Denver Model (ESDM), a comprehensive de-
MSEL—Mullen Scales of Early Learning                                velopmental behavioral intervention, for improving outcomes of tod-
ADOS—Autism Diagnostic Observation Schedule
VABS—Vineland Adaptive Behavior Scales                              dlers diagnosed with autism spectrum disorder (ASD).
RBS—Repetitive Behavior Scale                                       METHODS: Forty-eight children diagnosed with ASD between 18 and 30
This trial has been registered at www.clinicaltrials.gov            months of age were randomly assigned to 1 of 2 groups: (1) ESDM inter-
(identifier NCT00090415).
                                                                    vention, which is based on developmental and applied behavioral analytic
www.pediatrics.org/cgi/doi/10.1542/peds.2009-0958                   principles and delivered by trained therapists and parents for 2 years; or
doi:10.1542/peds.2009-0958                                          (2) referral to community providers for intervention commonly available in
Accepted for publication Jul 17, 2009                               the community.
Address correspondence to Geraldine Dawson, PhD, Autism             RESULTS: Compared with children who received community-intervention,
Speaks, 4120 Bioinformatics Building, University of North
Carolina, Chapel Hill, North Carolina. E-mail: gdawson@             children who received ESDM showed significant improvements in IQ, adap-
autismspeaks.org                                                    tive behavior, and autism diagnosis. Two years after entering intervention,
PEDIATRICS (ISSN Numbers: Print, 0031-4005; Online, 1098-4275).     the ESDM group on average improved 17.6 standard score points (1 SD: 15
Copyright © 2009 by the American Academy of Pediatrics              points) compared with 7.0 points in the comparison group relative to base-
FINANCIAL DISCLOSURE: Sally Rogers and Geraldine Dawson             line scores. The ESDM group maintained its rate of growth in adaptive behav-
are authors of Early Start Denver Model for Young Children with     ior compared with a normative sample of typically developing children. In con-
Autism from which they receive royalties.
                                                                    trast, over the 2-year span, the comparison group showed greater delays in
                                                                    adaptive behavior. Children who received ESDM also were more likely to expe-
                                                                    rience a change in diagnosis from autism to pervasive developmental disor-
                                                                    der, not otherwise specified, than the comparison group.
                                                                    CONCLUSIONS: This is the first randomized, controlled trial to demon-
                                                                    strate the efficacy of a comprehensive developmental behavioral inter-
                                                                    vention for toddlers with ASD for improving cognitive and adaptive
                                                                    behavior and reducing severity of ASD diagnosis. Results of this study
                                                                    underscore the importance of early detection of and intervention in
                                                                    autism. Pediatrics 2010;125:e17–e23
PEDIATRICS Volume 125, Number 1, January 2010                                                                                                 e17
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Autism spectrum disorder (ASD) is             ways. First, we maintained a high level         vices the parents chose; and (2) the
characterized by impairments in so-           of methodologic rigor, including gold-          assess-and-monitor (A/M) group re-
cial reciprocity and communication,           standard diagnostic criteria, random-           ceived yearly assessments with inter-
and stereotyped and repetitive behav-         ization, comprehensive outcome mea-             vention recommendations and refer-
iors, with onset during early child-          sures conducted by naive examiners,             rals for intervention from commonly
hood. Intellectual disability is present      high retention rates, and measures of           available community providers in the
in a large proportion of individuals.1        fidelity of implementation of a manual-          greater Seattle region.
With a prevalence of 1 per 150,2 autism       ized intervention.                              Children were evaluated by experi-
costs the United States $35 billion per       Second, to our knowledge, our study is          enced examiners naive to intervention
year.3 The lifetime per-capita societal       the first randomized, controlled trial of        status at baseline (preintervention), 1
cost of autism is $3.2 million, with lost     intervention for toddlers with autism;          year after onset of the intervention,
productivity and adult care among the         all children were younger than 30               and at either 2 years after onset of the
largest costs.4 Thus, early-intervention      months at entry. Given the recent rec-          intervention or at 48 months of age,
methods that can improve outcome              ommendation by the American Acad-               whichever yielded a longer time frame.
for individuals with ASD are of high          emy of Pediatrics that 18-month-old
importance.                                   children be screened for ASD,9 it is im-        Participants
The 1987 report by Lovaas5 of an early        perative that the efficacy of early-             Participants were recruited through
behavioral intervention that resulted         intervention models appropriate for
                                                                                              pediatric practices, Birth to Three cen-
in 49% of children in the study being         toddlers with ASD be demonstrated.
                                                                                              ters, preschools, hospitals, and state
mainstreamed into regular class-              Third, the intervention, the Early Start        and local autism organizations. Exclu-
rooms and showing significant IQ               Denver Model (ESDM),10 is a comprehen-          sion criteria included (1) a neurodevel-
gains created a groundswell of inter-         sive early behavioral intervention for in-      opmental disorder of known etiology
est among parents and professionals           fants to preschool-aged children with           (eg, fragile X syndrome), (2) significant
in early intervention and raised ques-        ASD that integrates applied behavior            sensory or motor impairment, (3) ma-
tions about early plasticity in children      analysis (ABA) with developmental and           jor physical problems such as a
with autism.6 Although subsequent in-         relationship-based approaches. The              chronic serious health condition, (4)
tervention studies, including a ran-          ESDM was designed to address the                seizures at time of entry, (5) use of psy-
domized, controlled trial,7 have docu-        needs of toddlers with ASD as young as          choactive medications, (6) history of a
mented improvements in IQ for a               12 months. The intervention is provided         serious head injury and/or neurologic
subgroup of children, questions re-           in a toddler’s natural environment (the         disease, (7) alcohol or drug exposure
garding the efficacy of early interven-        home) and is delivered by trained thera-        during the prenatal period, and (8) ra-
tion have remained. Many of the stud-         pists and parents. In our study, children       tio IQ below 35 as measured by mean
ies lacked methodologic rigor. Authors        received structured intervention at high        age equivalence score/chronological
of a recent meta-analysis of the effi-         intensity, consistent with the National         age on the visual reception and fine
cacy of early behavioral intervention         Research Council’s recommendation.11            motor subscales of the Mullen Scales
argued that stronger evidence that                                                            of Early Learning (MSEL).12 Children
early behavioral intervention results         PATIENTS AND METHODS
                                                                                              who developed seizures during the
in better outcomes than standard care         Study Procedures                                course of the study were not excluded.
is still needed.8                             Forty-eight children between 18 and 30          Inclusion criteria included age below
Our study was a randomized, con-              months of age diagnosed with autistic           30 months at entry, meeting criteria
trolled trial of early intensive behav-       disorder or pervasive developmental             for autistic disorder on the Toddler Au-
ioral intervention for young children         disorder (PDD), not otherwise speci-            tism Diagnostic Interview,13 meeting
with ASD that was funded by the Na-           fied (NOS), were randomly assigned to            criteria for autism or ASD on the Au-
tional Institute of Mental Health (Dr         1 of 2 groups: (1) the ESDM group re-           tism Diagnostic Observation Sched-
Dawson, principal investigator). It was       ceived yearly assessments, 20 hours/            ule,14 and a clinical diagnosis based on
hypothesized that the early interven-         week of the ESDM intervention from              Diagnostic and Statistical Manual of
tion would result in significant im-           University of Washington clinicians,            Mental Disorders, Fourth Edition
provements in cognitive abilities of          parent training, and parent delivery            (DSM-IV) criteria15 using all available
young children with ASD. The study dif-       for 5 or more hours/week of ESDM, in            information, residing within 30 min-
fered from previous ones in several           addition to whatever community ser-             utes of the University of Washington,
e18    DAWSON et al
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                                                                                                                                               ARTICLES
and willingness to participate in a ⱖ2-                                                        Assessed for eligibility
year intervention. At baseline, 18 chil-                                                              (n = 96)
dren in the A/M group and 21 in the                                                                                       Excluded (n = 45)
                                                 Enrollment
ESDM group received a DSM-IV diagno-                                                                                        Did not meet diagnostic
                                                                                                                            criteria (n = 38)
sis of autistic disorder. Six children in                                                                                   Met diagnostic criteria but
the A/M group and 3 in the ESDM group                                                                                       declined to participate in
                                                                                                                            randomization because of
received a diagnosis of PDD NOS. This                                                                                      demands of intervention
difference was not significant (Fisher’s                                                                                     (n = 7)
exact test, P ⫽ .231). The ethnicities                                                      Randomly assigned (n = 51)
                                                 Allocation
involved were Asian (12.5%), white
(72.9%), Latino (12.5%), and multira-
                                                              Excluded (n = 3)                Allocated to ESDM                Allocated to A/M
cial (14.6%). The male-to-female ratio                         Declined ESDM because of       group (n = 24)                   group (n = 24)
reflected the expected ratio in ASD of                          intervention requirements
                                                                (n = 2)
3.5:1.                                                         Subsequently diagnosed
                                                               with Rett syndrome (n = 1)     Time 1 assessment                Time 1 assessment
Retention rates were 100% (1-year)                                                            (n = 24)                         (n = 23)
                                                                                               Followed (n = 24)                Followed (n = 23)
and 100% (2-year) for the ESDM group                                                           Lost to follow-up                Lost to follow-up
                                                                                               (n = 0)                          (n = 1)
                                                 Follow-up
and 96% (1-year) and 88% (2-year) for
the A/M group, which yielded a sample
size of 24 in the ESDM and 21 in the A/M                                                      Time 2 assessment                Time 2 assessment
group at outcome. Figure 1 shows the                                                          (n = 24)                         (n = 21)
                                                                                               Followed (n = 24)                Followed (n = 21)
participant flowchart.                                                                          Lost to follow-up                Lost to follow-up
                                                                                               (n = 0)                          (n = 3)
Measures
                                                 Analysis
                                                                                              Analyzed (n = 24)                Analyzed (n = 21)
Autism Diagnostic Interview–Revised
The toddler version of the Autism Diag-
nostic Interview–Revised13 is a semi-           FIGURE 1
                                                Participant flowchart.
structured parent interview that as-
sesses autism symptoms across 3
domains: social relatedness; commu-
                                                were administered: fine motor, visual re-                 sameness, self-injurious behavior)
nication; and repetitive, restricted
                                                ception, expressive language, and recep-                 and a total score.
behaviors.
                                                tive language. T scores for subscales
                                                have a mean of 50 (SD: 10). The early-                   Randomization
Autism Diagnostic Observation
Schedule                                        learning composite score is a standard                   Participants were stratified into 2
                                                score with mean of 100 (SD: 15).                         groups on the basis of composite IQ at
The Autism Diagnostic Observation
                                                                                                         entry (⬍55 and 55) and gender to en-
Schedule (ADOS), WPS version,14 is a            Vineland Adaptive Behavior Scales
                                                                                                         sure comparable IQ and gender ratios
semistructured standardized observa-            The Vineland Adaptive Behavior Scales                    between groups. Within each of these
tion that measures autism symptoms              (VABS)17 are a parent interview that as-                 strata, randomization was conducted
in social relatedness, communication,           sesses social, communication, motor,                     by using random permuted blocks of 4.
play, and repetitive behaviors. A stan-         and daily living skills. They provide age-               The intervention groups did not differ
dardized severity score based on                equivalent and standard scores for                       at baseline in severity of autism symp-
codes within these domains can be cal-          several subscales, including expres-                     toms based on ADOS scores, chrono-
culated to compare autism symptoms              sive and receptive language and social                   logical age, IQ, gender, or adaptive be-
across modules.16                               adaptive functioning.                                    haviors (see Table 1).
Mullen Scales of Early Learning                 Repetitive Behavior Scale
                                                                                                         Intervention Groups
(MSEL)                                          The Repetitive Behavior Scale (RBS)18
The MSEL12 are a standardized develop-          is a parent questionnaire that charac-                   ESDM Group
mental test for children from birth to 68       terizes the severity of repetitive behav-                The ESDM group was provided with in-
months of age. Four of the 5 subscales          iors, yielding 6 subdomain scores (eg,                   tervention by trained therapists for
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TABLE 1 Baseline Measures for ESDM and A/M Groups                                                                therapist-delivered intervention hours
                                            A/M Group               ESDM Group             F      MS       P     per week were made available, the ac-
                                     Mean       SD       N     Mean       SD       N                             tual mean was 15.2 hours (SD: 1.4) be-
Age at study entry, mo               23.1        3.9    24      23.9       4.0     24     0.48     7.52   .490   cause of illnesses, vacations, and so
MSEL                                                                                                             on. Parents reported spending an av-
Early-learning compositea            59.4        8.6    24      61.0       9.2     24     0.40    31.69   .530
                                                                                                                 erage of 16.3 hours/week (SD: 6.2) us-
Receptive languageb                  21.2        3.8    24      21.1       4.7     24     0.01     0.19   .920
Expressive languageb                 26.0        8.6    24      24.5       7.2     24     0.48    30.08   .492   ing ESDM strategies. The ESDM group
Visual receptionb                    30.8        8.9    24      33.2      11.0     24     0.70    70.08   .406   reported an average of 5.2 hours/week
Fine motorb                          30.6       10.7    24      33.9      11.9     24     1.02   130.02   .318   (SD: 2.1) in other therapies (eg, speech
VABS
Adaptive behavior compositea         69.9        7.3    24      69.5       5.7     24     0.04     1.69   .844   therapy, developmental preschool)
Communicationa                       69.6        7.3    24      68.4       7.6     24     0.32    17.52   .577   over the study enrollment period.
Socializationa                       72.4        9.4    24      73.8       7.7     24     0.29    21.33   .594   Other therapies were documented by
Daily living skillsa                 86.8       10.0    24      87.3      11.4     24     0.03     3.52   .381
Motor skillsa                        72.5        6.5    24      70.9       6.2     24     0.78    31.69   .862
                                                                                                                 using an intervention history interview
ADOS severity score                   6.9        1.7    24       7.2       1.7     24     0.35     1.02   .557   administered every 6 months.
RBS total                            21.5       19.2    24      15.2      10.8     24     1.93   468.75   .171
No significant differences among baseline measures were found (P ⬎ .10 on all measures).                          A/M Group
a Standard score (mean: 100 关SD: 15兴).
b T score (mean: 50 关SD: 10兴).                                                                                   Children who were randomly assigned
                                                                                                                 to the A/M group received comprehen-
                                                                                                                 sive diagnostic evaluations, interven-
2-hour sessions, twice per day, 5 days/                      objectives from the curriculum that                 tion recommendations, and commu-
week, for 2 years. A detailed interven-                      they viewed as high priority.                       nity referrals at baseline and again at
tion manual and curriculum were                              Intervention programs were super-                   each of the 2 follow-up assessments.
used.19 One or both parents were pro-                        vised by a graduate-level, trained lead             Families were given resource manuals
vided with parent training from the pri-                     therapist who had a minimum of 5                    and reading materials at baseline and
mary therapist during semimonthly                            years’ experience providing early in-               twice yearly throughout the study. The
meetings, during which the principles                        tervention to young children with au-               A/M group reported an average of 9.1
and specific techniques of ESDM were                          tism, with ongoing consultation from a              hours of individual therapy and an
taught. Parents were asked to use                                                                                average of 9.3 hours/week of group in-
                                                             clinical psychologist, speech-language
ESDM strategies during daily activities                                                                          terventions (eg, developmental pre-
                                                             pathologist, and developmental behav-
and to keep track of the number of                                                                               school) across the 2-year period dur-
                                                             ioral pediatrician. An occupational
hours during which they used these                                                                               ing which the intervention study was
                                                             therapist provided consultation as
strategies. ESDM uses teaching strate-                                                                           conducted. In the greater Seattle area,
                                                             needed. Intervention objectives and
gies that involve interpersonal ex-                                                                              there are a number of Birth to Three
                                                             strategies were reviewed, and the in-
change and positive affect, shared en-                                                                           centers that provide interventions,
                                                             tervention was observed at least bi-
gagement with real-life materials and                                                                            speech and language therapy, and
                                                             weekly by the lead therapist and every
activities, adult responsivity and sensi-                                                                        occupational therapy. Developmen-
                                                             3 months by the speech-language pa-
tivity to child cues, and focus on verbal                                                                        tal preschool programs vary but typ-
                                                             thologist. Intervention was delivered
and nonverbal communication, based                                                                               ically include special education and
                                                             by therapists who typically held a bac-             related services. There are a number
on a developmentally informed curric-
                                                             calaureate degree, received 2 months                of private ABA providers in the
ulum that addresses all developmental
                                                             of training by the lead therapist, and              community.
domains. Teaching strategies are con-
sistent with the principles of ABA, such                     met weekly with the lead therapist.
as the use of operant conditioning,                          Therapists were trained to compe-                   Data Analysis
shaping, and chaining. Each child’s                          tence, defined as completing course-                 The effect of ESDM intervention was as-
plan is individualized. There is a strong                    work, passing tests, mastering the in-              sessed by using repeated-measures
parent-family role responsive to each                        tervention, demonstrating fidelity of                analysis of variance, with a priori con-
family’s unique characteristics. Par-                        85% of maximum scores on the fidelity                trasts that compared baseline scores
ents are taught the basic ESDM strate-                       instrument, and maintaining ongoing                 with 1- and 2-year outcome scores. The
gies and asked to use them during ev-                        fidelity.20                                          primary outcome measures were the
eryday activities such as feeding, bath                      ESDM intervention hours were sys-                   MSEL composite standard score and
time, and play. Parents chose teaching                       tematically recorded. Although 20                   the VABS composite standard score.
e20      DAWSON et al
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                                                                                                                                                     ARTICLES
TABLE 2 Child Outcomes After 1 and 2 Years of Study Participation
                                          1-y Outcome                                 2-y Outcome                   Group ⫻ Time             Group ⫻ Time
                                                                                                                     (Baseline vs           (Baseline vs 2-y)
                              A/M (N ⫽ 23)           ESDM (N ⫽ 24)        A/M (N ⫽ 21)           ESDM (N ⫽ 24)           1-y)
                          Mean      SD    ⌬        Mean   SD     ⌬      Mean   SD     ⌬        Mean   SD      ⌬       F      MS       P       F       MS        P
Chronological age, mo      38.1     3.8   15.3     38.8    4.4   14.9   52.1    4.3   29.3     52.4    3.4   28.5   0.95      2.18 .334 1.27           6.91 .266
MSEL
Early-learning             64.0    13.8      4.4   76.4   23.4   15.4   66.3   15.3      7.0   78.6   24.2   17.6   5.99    1416.90 .018 4.31 1264.38 .044
   composite
Receptive language         31.1    11.1   9.8      38.9   15.4  17.8    31.5   10.6  10.2      40.0   16.3   18.9   4.00    745.21   .051    4.14 843.56 .048
Expressive language        33.0    11.5   6.7      36.1   14.2  11.6    30.0    9.2   4.0      36.6   13.6   12.1   1.99    290.43   .165    4.88 748.07 .033
Visual reception           29.0    10.7 ⫺1.7       38.8   16.4   5.6    34.5   13.0   4.5      41.0   17.9    7.8   4.22    621.97   .046    0.63 126.23 .433
Fine motor                 26.1     8.6 ⫺5.0       32.7   11.7 ⫺1.3     28.5    9.5 ⫺2.8       33.5   12.2   ⫺0.4   1.32    161.35   .256    0.46   63.81 .503
VABS                       63.7     8.8 ⫺6.3       65.7    9.8 ⫺3.8     59.1    8.8 ⫺11.2      68.7   15.9   ⫺0.8   0.85     71.61   .360    7.05 1181.82 .011
Communication              71.0    13.0   1.2      73.5   11.7   5.0    69.4   15.8 ⫺0.7       82.1   21.8   13.7   1.38    175.69   .246    6.38 2300.98 .015
Socialization              68.9    12.1 ⫺3.5       70.0    9.9 ⫺3.8     63.1    9.3 ⫺8.9       69.2   11.6   ⫺4.6   0.01      1.15   .934    1.29 204.57 .263
Daily living skills        65.3     7.1 ⫺7.4       65.6    8.6 ⫺5.3     58.0    8.1 ⫺14.5      64.7   12.4   ⫺6.2   0.89     51.78   .350    6.73 773.34 .013
Motor skills               70.7    12.2 ⫺15.9      75.1   14.4 ⫺12.2    64.1   12.3 ⫺23.1      77.4   19.8   ⫺9.9   0.99    157.43   .326    7.40 1881.65 .009
ADOS severity score         7.3     2.1   0.4       6.5    1.5 ⫺0.7      7.3    1.8   0.3       7.0    1.9   ⫺0.2   3.38     13.15   .072    0.66    3.29 .422
RBS total                  23.3    17.5   1.0      15.5   12.3   0.9    22.0   16.3 ⫺0.6       16.7   13.1    2.5   0.001     0.19   .976    0.37   92.50 .545
⌬ indicates mean change from baseline.
Secondary outcome measures were                           improvement in the A/M group, a dif-                 the ESDM group, whereas the A/M
the ADOS severity score,16 the RBS,18                     ference that fell just short of statis-              group improved 10.2 and 4.0 points,
MSEL, and VABS subscale scores, and                       tical significance.                                   respectively.
changes in diagnostic status (autistic                    As a whole, children gained raw                      The ESDM and A/M groups signifi-
disorder, PDD NOS, and no diagnosis).                     score points in the daily living skills              cantly differed in terms of their
RESULTS                                                   subscale of the VABS; however,                       adaptive behavior as measured by
                                                          progress was much slower in rela-                    the VABS composite standard scores
No serious adverse effects related to                     tion to the VABS normative sample                    at the 2-year outcome (see Fig 2). The
the intervention were reported during                     between baseline and 1 year. The                     ESDM group showed similar stan-
the 2-year period.
                                                          groups did not differ in terms of                    dard scores at the 1- and 2-year out-
1-Year Outcome                                            adaptive behavior, measured by the                   comes, indicating a steady rate of de-
                                                          VABS composite standard score, af-                   velopment, whereas the A/M group,
Table 2 displays statistics for 1- and
                                                          ter 1 year (the ESDM group showed a                  on average, showed an 11.2-point av-
2-year outcomes, change scores rela-
                                                          3.8-point decline, and the A/M group                 erage decline. Thus, the A/M group’s
tive to baseline, and group compari-
                                                          showed a 6.3-point decline). The                     delays in overall adaptive behavior
sons for primary and secondary mea-
                                                          groups did not differ in terms of their              became greater when compared
sures. Significant intervention effects
                                                          ADOS severity scores or RBS total                    with the normative sample. The A/M
were found for cognitive ability after 1
                                                          score after 1 year of intervention.                  group showed average declines in
year on the MSEL composite standard
scores. The ESDM group demonstrated                                                                            standard scores that were twice as
                                                          2-Year Outcome                                       great as those in the ESDM group in
an average IQ increase of 15.4 points
(⬎1 SD) compared with an increase of                      Two years after the baseline assess-                 the domains of socialization, daily liv-
4.4 points in the A/M group. The visual                   ment, the ESDM group showed signif-                  ing skills, and motor skills. The
reception subscale was the only indi-                     icantly improved cognitive ability,                  groups did not differ in terms of their
vidual subscale on the MSEL on                            measured by MSEL composite stan-                     ADOS severity scores or RBS total
which the groups significantly dif-                        dard scores, which increased 17.6                    score after 2 years of intervention.
fered at the 1-year outcome. The                          points compared with 7.0 points in
ESDM group gained 5.6 T-score                             the A/M group. The bulk of this                      Diagnosis
points, whereas the A/M group de-                         change seems to have been a result                   At baseline, the diagnoses in each
clined 1.7 points. The ESDM group im-                     of receptive and expressive lan-                     group were not significantly differ-
proved 17.8 points on receptive lan-                      guage, which showed increases of                     ent (Fisher’s exact test, P ⫽ .461)
guage compared with a 9.8-point                           18.9 and 12.1 points, respectively, for              and were distributed as follows:
PEDIATRICS Volume 125, Number 1, January 2010                                                                                                                   e21
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                                                                                                 sample, whereas the community-
                                                                                                 based intervention group continued
                                                                                                 to fall farther behind in adaptive be-
                                                                                                 havior. Given the importance of
                                                                                                 adaptive behavior for everyday func-
                                                                                                 tioning at home and school, the fact
                                                                                                 that the ESDM group did not continue
                                                                                                 to fall farther behind is likely to af-
                                                                                                 fect ability to function in less-
                                                                                                 restrictive environments. This dem-
                                                                                                 onstrates that the ESDM intervention
                                                                                                 accelerates overall development and
                                                                                                 is generalizing to everyday life.
FIGURE 2                                                                                         Whereas 71% of the children in the
Mean scores on the MSEL (left) and the VABS composite (right) for children in the ESDM and A/M   group that received community-
groups 1 and 2 years after entering study. Error bars indicate ⫾1 SD.
                                                                                                 based intervention retained their di-
                                                                                                 agnosis of autistic disorder over the
                                                                                                 2-year period, only 56% of children in
ESDM, 21 with autistic disorder and 3            DISCUSSION                                      the ESDM group did so. The diagnosis
with PDD NOS; A/M, 18 with autistic              Recommendations by the American                 of 7 children (30%) in the ESDM
disorder and 6 with PDD NOS. At the              Academy of Pediatrics9 that all chil-           group changed from autistic dis-
2-year outcome, 15 (62.5%) children              dren be screened for autism at 18               order to PDD NOS, whereas this
in the ESDM group had the same di-               months of age oblige the develop-               only occurred for 1 child (5%) in
agnosis (14 with autistic disorder, 1            ment of interventions that are appro-           the community-intervention group.
with PDD NOS) and 15 (71.4%) chil-               priate for toddlers with ASD. To our            These diagnostic assessments were
dren in the A/M group had the same               knowledge, this study is the first to            conducted by experienced clinicians
diagnosis (all 15 with autistic disor-           demonstrate the efficacy of an inten-            who were naive with respect to
der). Diagnosis improved (baseline               sive intervention designed for tod-             intervention-group status. However,
autistic disorder to PDD NOS at year             dlers with ASD as young as 12                   this change in diagnostic severity
2) for 7 (29.2%) children in the ESDM                                                            was not reflected in significant dif-
                                                 months of age. After 2 years of inter-
group but for only 1 (4.8%) child in                                                             ferences in the ADOS severity scores.
                                                 vention, children provided with the
the A/M group. However, the diagno-                                                              This lack of correspondence be-
                                                 ESDM19 showed significant improve-
sis changed from PDD NOS at base-                                                                tween measures is difficult to inter-
                                                 ments in IQ, adaptive behavior, and
line to autistic disorder at year 2 for                                                          pret, because the child’s perfor-
                                                 diagnostic status compared with
                                                                                                 mance in the ADOS contributes to
2 (8.3%) children in the ESDM group              children who received community in-
                                                                                                 clinical diagnosis. However, other
and 5 (23.8%) children in the A/M                terventions. Consistent evidence of
                                                                                                 behaviors, including parental report,
group. Thus, children who received               improvement in communicative abil-              also contribute to overall clinical
ESDM were significantly more likely               ities in the ESDM group was found, as           diagnosis. The repetitive-behavior
to have improved diagnostic status               demonstrated by gains in receptive              scores also did not change over time
at the 2-year outcome compared with              and expressive language scores on               in either group.
children in the A/M group, as as-                the MSEL subscales and the VABS
sessed by using Fisher’s exact test 2            communication subscale. Significant              CONCLUSIONS
(intervention groups) ⫻ 2 (improved              improvement for the ESDM group                  The outcomes of this study, which in-
versus worsened diagnosis) contin-               was found for overall adaptive be-              volve an increase in IQ scores of 17
gency table (P ⫽ .041). Fisher’s exact           havior, communication, daily living             points (⬎1 SD) and significant gains in
test for the 2 (intervention groups)             skills, and motor skills. Specifically,          language and adaptive behavior, com-
⫻ 3 (diagnostic change: no change                the ESDM group, although still signif-          pare favorably with other controlled
versus improved versus worsened                  icantly delayed in adaptive behavior,           studies of intensive early intervention
diagnosis) contingency table was                 was able to keep pace with the rate             (eg, Smith et al [2000],7 which deliv-
just short of significance (P ⫽ .060).            of change of the VABS normative                 ered discrete trial intervention for ⬎2
e22    DAWSON et al
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                                                                                                                                               ARTICLES
years for 25– 40 hours/week). The                     The results of this study suggest that                ACKNOWLEDGMENTS
group differences reported from our                   the ESDM model,19 an intervention ap-                 This study was supported by National
study are larger than those produced                  proach that uses teaching strategies                  Institute of Mental Health grant
by other comparative trials of develop-               of ABA that are delivered within an af-               U54MH066399 (to Dr Dawson).
mental behavioral approaches, which                   fectively rich, relationship-focused                  We acknowledge the contributions of
were conducted for briefer periods of                 context, can be effective for improving               the parents and children who took
time and with fewer hours of delivery                 outcomes of young children with au-                   part in this study and the support and
per week.21,22 Whether the children will              tism. Parents’ use of these strategies                effort of numerous undergraduate and
sustain their gains over a longer term                at home during their daily activities                 graduate students and staff who are
is an important question that will re-                likely was an important ingredient of                 part of the University of Washington
quire follow-up study.                                its success.                                          Autism Center.
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PEDIATRICS Volume 125, Number 1, January 2010                                                                                                           e23
                       Downloaded from www.aappublications.org/news at Indonesia:AAP Sponsored on October 13, 2019
Randomized, Controlled Trial of an Intervention for Toddlers With Autism: The
                          Early Start Denver Model
  Geraldine Dawson, Sally Rogers, Jeffrey Munson, Milani Smith, Jamie Winter,
             Jessica Greenson, Amy Donaldson and Jennifer Varley
                            Pediatrics 2010;125;e17
  DOI: 10.1542/peds.2009-0958 originally published online November 30, 2009;
Updated Information &              including high resolution figures, can be found at:
Services                           http://pediatrics.aappublications.org/content/125/1/e17
References                         This article cites 12 articles, 1 of which you can access for free at:
                                   http://pediatrics.aappublications.org/content/125/1/e17#BIBL
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           Downloaded from www.aappublications.org/news at Indonesia:AAP Sponsored on October 13, 2019
Randomized, Controlled Trial of an Intervention for Toddlers With Autism: The
                          Early Start Denver Model
  Geraldine Dawson, Sally Rogers, Jeffrey Munson, Milani Smith, Jamie Winter,
             Jessica Greenson, Amy Donaldson and Jennifer Varley
                            Pediatrics 2010;125;e17
  DOI: 10.1542/peds.2009-0958 originally published online November 30, 2009;
  The online version of this article, along with updated information and services, is
                         located on the World Wide Web at:
               http://pediatrics.aappublications.org/content/125/1/e17
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