Trial of Center-Based Early Start Denver Model vs. Pivotal Response Treatment in Children With Autism

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-4
SponsorStanford University

About this trial

The goal of this study is to compare two well-established early autism interventions, Early Start Denver Model (ESDM) and Pivotal Response Treatment (PRT), to better understand which approach is most effective for improving communication skills in young children with autism and which children may benefit most from each treatment. Additionally, after completing either the ESDM or PRT, some participants who meet specific clinical criteria may be offered home-based Developmental Reciprocity Treatment (DRT). The study will include boys and girls 2 to 4 years 11 months old diagnosed with ASD. The main questions this study aims to answer are whether center-based ESDM and center-based PRT improve communication skills in young children with autism, and whether certain children respond better to one treatment approach than the other. Participants will be randomly assigned to either ESDM or PRT for 24 weeks in a center-based program, attend treatment session 4 days per week (\~3 hours/day), complete developmental and autism assessments at baseline, 12 weeks, and 24 weeks, have a parent participate in weekly parent training sessions, and complete follow-up assessments at weeks 36 and 48.

Eligibility criteria

Qualifiers

Children must be between 2 and 4 years, 11 months of age at enrollment

Confirmed diagnosis of autism spectrum disorder based on standardized diagnostic assessments and clinical judgment

Demonstrated significant language delay as determined by standardized language measures

Ability to participate in study assessments and intervention procedures

Disqualifiers

Current or lifetime diagnosis of a severe psychiatric disorder (e.g., bipolar disorder)

Presence of an active or unstable medical condition (e.g., uncontrolled seizure disorder or significant cardiac disease)

Child's primary language is not English

Prior adequate trial of PRT or ESDM

Trial design

Treatments tested in this trial

  • Early Start Denver Model (ESDM)
  • Pivotal Response Treatment (PRT)
  • Developmental Reciprocity Treatment (DRT)

Treatment groups

140 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Stanford University

Lead sponsor

John and Marcia Goldman Foundation

Collaborator