Dawson et al., 2010

Study DescriptionInterventionInclusion/Exclusion
Criteria/Population
Baseline MeasuresOutcomes
Author:
Dawson et al., 2010
Country:
US
Practice setting:
Academic
Intervention setting:
Home
Enrollment period:
NR
Funding:
NIH
Author industry relationship disclosures:
2 of 8
Early Start Denver Model for Young Children with Autism (royalties)
Design:
RCT
Intervention:
Early Start Denver Model:
20 hrs/week of ESDM, parent training, parent delivery for ≥ 5 hrs/week of ESDM, community services chosen by parents
Assess-and-monitor:
Families given resource manuals, intervention recommendations, and referrals for intervention at baseline and 2 follow-up assessments
Duration:
2 years
Frequency:
2 hour sessions, twice per day, 5 days/week
Assessments:
ADI-R; ADOS; MSEL (fine motor, visual reception, expressive language and receptive language scales); VABS; RBS Yearly assessments conducted by University of Washington examiners blind to group status for both groups (G1 & G2) and by community providers (G2)
Groups:
G1: Early Start Denver Model
G2: assess-and-monitor
Provider:
  • Bachelor’s level therapists supervised by PhD level clinician with consultation from Clinical psychologist Speech-language pathologist Developmental behavioral pediatrician Occupational therapist
Measure of treatment fidelity reported:
Yes
Inclusion criteria:
  • Age < 30 months at intake
  • Met criteria for autistic disorder on the Toddler Autism Diagnostic Interview
  • Met ADOS criteria for autism or ASD
  • Clinical diagnosis based on DSM-IV criteria using all available information
  • Resides within 30 minutes of the University of Washington
  • Willingness to participate in ≥ 2 year intervention
Exclusion criteria:
  • Neurodevelopmental disorder of known etiology (such as fragile x syndrome)
  • Significant sensory or motor impairment
  • Major physical problems such as a chronic serious health condition
  • Seizures at time of entry
  • Use of psychoactive medications
  • History of a serious head injury and/or neurologic disease
  • Alcohol or drug exposure during the prenatal period
  • Ratio IQ below 35 as measured by mean age equivalence score/chronological age on the visual reception and fine motor subscales of the MSEL
Age, months ± SD:
G1: 23.9 ± 4.0
G2: 23.1 ± 3.9
G1/G2: P = 0.490
Mental age:
NR
Gender, male-to-female ratio:
3.5:1
Overall ratings:
ADOS severity score, mean ± SD:
G1: 7.2 ± 1.7
G2: 6.9 ± 1.7
G1/G2: P = 0.557
Social skills:
VABS socialization score, mean ± SD:
G1: 73.8 ± 7.7
G2: 72.4 ± 9.4
G1/G2: P = 0.594
IQ or Early Learning Composite Score:
MSEL scale score, mean ± SD:
Early-learning composite:
G1: 61.0 ± 9.2
G2: 59.4 ± 8.6
G1/G2: P = 0.530
Receptive language:
G1: 21.1 ± 4.7
G2: 21.2 ± 3.8
G1/G2: P = 0.920
Expressive language:
G1: 24.5 ± 7.2
G2: 26.0 ± 8.6
G1/G2: P = 0.492
Visual reception:
G1: 33.2 ± 11.0
G2: 30.8 ± 8.9
G1/G2: P = 0.406
VABS communication score, mean ± SD:
G1: 68.4 ± 7.6
G2: 69.6 ± 7.3
G1/G2: P = 0.577
Repetitive Behavior:
RBS total score, mean ± SD:
G1: 15.2 ± 10.8
G2: 21.5 ± 19.2
G1/G2: P = 0.171
Overall ratings:
ADOS severity score, 2 years, mean ± SD:
G1: 7.0 ± 1.9
G2: 7.3 ± 1.8
G1/G2: P = 0.422
Diagnostic category, 2 years, n: Autism:
G1: 16
G2: 20
PDD-NOS:
G1: 8
G2: 1
Social skills:
VABS socialization score, 2 years, mean ± SD:
G1: 69.2 ± 11.6
G2: 63.1 ± 9.3
G1/G2: P = 0.263
IQ or Early Learning Composite Score:
MSEL scale score, 2 years, mean ± SD:
Early-learning composite:
G1: 78.6 ± 24.2
G2: 66.3 ± 15.3
G1/G2: P = 0.044
Receptive language:
G1: 40.0 ± 16.3
G2: 31.5 ± 10.6
G1/G2: P = 0.048
Expressive language:
G1: 36.6 ± 13.6
G2: 30.0 ± 9.2
G1/G2: P = 0.033
Visual reception:
G1: 41.0 ± 17.9
G2: 34.5 ± 13.0
G1/G2: P = 0.433
Co-interventions held stable during treatment:
Yes
Concomitant therapies:
NR
N at enrollment:
G1: 24
G2: 24
N at follow-up (%):
Year one:
G1: 24 (100)
G2: 23 (96)
Year two:
G1: 24 (100)
G2: 21 (88)
Race/ethnicity, %:
Asian: 12.5
White: 72.9
Latino: 12.5
Multiracial: 14.6
SES:
Maternal education: NR
Household income: NR
Diagnostic approach:
Referral and confirmed in study
Diagnostic tool/method:
Toddler Autism Diagnostic Interview, ADOS, DSM-IV
Diagnostic category, n:
Autism:
G1: 21
G2: 18
PDD-NOS:
G1: 3
G2: 6
Other characteristics:
NR
Adaptive behavior:
VABS adaptive behavior composite score, mean ± SD:
G1: 69.5 ± 5.7
G2: 69.9 ± 7.3
G1/G2: P = 0.844
VABS daily living skills score, mean ± SD:
G1: 87.3 ± 11.4
G2: 86.8 ± 10.0
G1/G2: P = 0.381
Motor skills:
MSEL fine motor score, mean ± SD:
G1: 33.9 ± 11.9
G2: 30.6 ± 10.7
G1/G2: P = 0.318
VABS motor skills score, mean ± SD:
G1: 70.9 ± 6.2
G2: 72.5 ± 6.5
G1/G2: P = 0.862
Communication/language:
VABS communication score, 2 years, mean ± SD:
G1: 82.1 ± 21.8
G2: 69.4 ± 15.8
G1/G2: P = 0.015
Repetitive behavior:
RBS total score, 2 years, mean ± SD:
G1: 16.7 ± 13.1
G2: 22.0 ± 16.3
G1/G2: P = 0.545

Adaptive behavior:
VABS adaptive behavior composite score, 2 years, mean ± SD:
G1: 68.7 ± 15.9
G2: 59.1 ± 8.8
G1/G2: P = 0.011
VABS daily living skills score, 2 years, mean ± SD:
G1: 64.7 ± 12.4
G2: 58.0 ± 8.1
G1/G2: P = 0.013
Motor skills:
MSEL fine motor score, 2 years, mean ± SD:
G1: 33.5 ± 12.2
G2: 28.5 ± 9.5
G1/G2: P = 0.503
VABS motor skills score, 2 years, mean ± SD:
G1: 77.4 ± 19.8
G2: 64.1 ± 12.3
G1/G2: P = 0.009
Harms:
NR
Modifiers:
NR

From: Appendix C, Evidence Tables

Cover of Therapies for Children With Autism Spectrum Disorders
Therapies for Children With Autism Spectrum Disorders.
Comparative Effectiveness Reviews, No. 26.
Warren Z, Veenstra-VanderWeele J, Stone W, et al.

PubMed Health. A service of the National Library of Medicine, National Institutes of Health.