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

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.

NCT Number	NCT07522190
Lead Sponsor	Stanford University Collaborators: John and Marcia Goldman Foundation
Conditions	Autism Spectrum Disorder (ASD), Autism
Enrollment	140 participants
Start Date	2027-01
Primary Completion	2037-01 (estimated)
Study Completion	2037-01 (estimated)
Updated on ClinicalTrials.gov	2026-07-08