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

Summary

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.

Conditions

• Autism Spectrum Disorder (ASD)
• Autism

Interventions

BEHAVIORAL

Early Start Denver Model (ESDM)

ESDM is a comprehensive, play-based early intervention that integrates applied behavior analysis with developmental and social-pragmatic approaches. ESDM uses a structured curriculum to systematically target communication, social engagement, imitation, cognition, and play skills. The intervention is delivered within joint activity routines that emphasize the interactions between the child and adult. Goals are individualized and embedded into naturalistic play and daily routines to support developmental progress. Children will participate in center-based treatment 4 days per week for 3 hours per day for 24 weeks. The parent will be encouraged to practice the intervention at home and submit one 10-minute parent-child interaction video regularly during the 24 weeks.

BEHAVIORAL

Pivotal Response Treatment (PRT)

PRT s a naturalistic, play-based intervention based on principles of applied behavior analysis. Instead of working on developing skills in isolation, PRT focuses on "pivotal" areas of development like motivation, responsivity to cues, and self-initiation. The idea is that working on these areas will lead to broad improvements across communication and behavior. Through the intervention, therapists and parents integrate various strategies into child-led play to increase communication and engagement. Children will participate in center-based treatment 4 days per week for 3 hours per day for 24 weeks. The parent will be encouraged to practice the intervention at home and submit one 10-minute parent-child interaction video regularly during the 24 weeks.

BEHAVIORAL

Developmental Reciprocity Treatment (DRT)

DRT is a relationship-based, developmental intervention that targets the foundations of social reciprocity such as shared attention, emotional engagement, and back-and-forth interaction. DRT emphasizes building the child's capacity for mutual engagement with parents or therapists through interactions that follow the child's lead. This will be a 24-week home-based intervention for with weekly parent training

Sponsors & Collaborators

• John and Marcia Goldman Foundation

  collaborator UNKNOWN

• Stanford University

  lead OTHER

Principal Investigators

• Antonio Hardan, MD · Stanford University

• Grace Gengoux, PhD · Stanford University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

2 Years

Max Age

4 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2027-01-31

Primary Completion

2037-01-31

Completion

2037-01-31

Countries

• United States

Study Locations