Early Start Denver Model vs Pivotal Response Treatment for Autism

Overseen By Juliya Pattammady, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Severe psychiatric disorder, Unstable medical condition, Non-English primary language, Prior PRT or ESDM, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 40

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

Antonio Hardan, MD

Principal Investigator

Stanford University

Grace Gengoux, PhD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

Inclusion Criteria

I have been diagnosed with autism spectrum disorder.

My child is between 2 and 4 years, 11 months old.

I have been on the same treatment or medication for at least one month.

Exclusion Criteria

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

I receive more than 15 hours a week of in-home behavior therapy.

Child's primary language is not English

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to either ESDM or PRT for 24 weeks in a center-based program, attending treatment sessions 4 days per week (~3 hours/day), with developmental and autism assessments at baseline, 12 weeks, and 24 weeks, and weekly parent training sessions.

24 weeks

4 visits per week (in-person)

Follow-up

Participants complete follow-up assessments to monitor communication skills and developmental progress.

24 weeks

Assessments at weeks 36 and 48

Optional Extension

Participants who meet specific clinical criteria may be offered home-based Developmental Reciprocity Treatment (DRT).

What Are the Treatments Tested in This Trial?

Interventions

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

How Is the Trial Designed?

Group I: Pivotal Response Treatment (PRT) Experimental Treatment 1 Intervention

Group II: Early Start Denver Model (ESDM) Experimental Treatment 1 Intervention

Group III: Developmental Reciprocity Treatment (DRT) Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

John and Marcia Goldman Foundation

Collaborator

Trials

1

Recruited

20+