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N/A N=118 Randomized Single-blind Treatment

Intensive Intervention for Toddlers With Autism (EARLY STEPS)

Autism · Autism Spectrum Disorder

Enrolled (actual)
118
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcome: Primary: Language Age Equivalent — 39.59; 36.09 language age in months — p=.03

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Early Start Denver Model (Behavioral); Standard community care (Behavioral)
Age
Pediatric · 0+ yrs
Sex
All
Sponsor
University of California, Davis
Primary completion
Jul 2013

Outcome Measures

OutcomeResultp-value
PRIMARY
Language Age Equivalent
39.59; 36.09 .03 sig
SECONDARY
Overall Developmental Quotient (DQ)
83.09; 79.14
SECONDARY
Adaptive Behavior Age Equivalent Scores
39.76; 36.69
SECONDARY
Autism Severity
6.69; 6.19

Summary

Goals of the current project: (1) Does the Early Start Denver Model experimental intervention for toddlers with autism reduce disability associated with autism significantly more than standard community interventions?; and (2) What environmental, child, and biological characteristics mediate and moderate intervention response and outcomes at age 4?

Eligibility Criteria

Inclusion criteria: (1) 12-24 months of age at the time of telephone screening and living within 60 minutes of the university clinic; (2) ambulatory; (3) unimpaired hand use; (4) parent agreement to have a caregiver present during all home sessions; (5) attendance at all intake sessions; (6) permission to videotape evaluations and ESDM treatment; (7) English as one primary language of the parent; (8) unimpaired hearing and vision; (9) developmental quotient of 35 or higher on the Mullen Scales of Early Learning (MSEL); and (10) meets all of these ASD diagnostic criteria: (a) Autism Diagnostic Observation Scale for Toddlers (ADOS-T) cutoff score of 12 if child produces no words or 10 if child produces some words; (b) agreement by two experienced psychologists that ASD is present; and that child meets DSM-IV criteria for Autistic Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDDNOS). 5,7,8 Exclusion criteria: (1) serious parental substance abuse; (2) parental self-report of bipolar disorder or psychosis; (3) known genetic syndromes; (4) serious medical conditions (e.g., encephalitis, concussion, seizure disorder); (5) significant sensory impairment; (6) birth weight <1600 grams and/or gestational age < 34 weeks; (7) history of intraventricular hemorrhage; (8) known exposure to neurotoxins (including alcohol, drugs); (9) non-English-speaking parents; and for the ESDM-assigned group only, (10) current enrollment in an intensive, 1:1 delivered behavioral intervention of more than 10 hours per week. There was no other restrictions on additional community-based treatment.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00698997). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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