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

April 14, 2026 updated by: Antonio Hardan, Stanford University

Randomized Controlled Trial of Center-Based Early Start Denver Model (ESDM) vs. Pivotal Response Treatment (PRT) 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94305-5719
        • Stanford University
        • Principal Investigator:
          • Antonio Hardan, MD
        • Contact:
        • Principal Investigator:
          • Grace Gengoux, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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
  • At least one English-speaking parent or caregiver available to participate in parent training and research measures
  • Receiving stable community-based treatments or medications for at least one month prior to baseline, with no anticipated changes during the study period

Exclusion Criteria:

  • 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
  • Receipt of more than 15 hours per week of in-home applied behavior analysis services
  • Inability to complete study assessments or procedures to obtain valid data

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pivotal Response Treatment (PRT)
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.
Experimental: Early Start Denver Model (ESDM)
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.
Experimental: Developmental Reciprocity Treatment (DRT)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Week 24 Clinical Global Impressions - Improvement (CGI-I)
Time Frame: Baseline, Week 12, Week 24, Week 36, Week 48
A clinician rating that measures how much a child's overall symptoms and functioning have improved or worsened compared to the start of treatment. The CGI ratings will be assessed by a psychologist blind to group assignment and treatment phase, and will specifically focus on social and communication skills.
Baseline, Week 12, Week 24, Week 36, Week 48

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline on Functional utterances during Structured Laboratory Observation (SLO)
Time Frame: Baseline, Week 12, Week 24, Week 36, Week 48
The number of meaningful spoken words or phrases a child uses to communicate during a structured play interaction with the parent.
Baseline, Week 12, Week 24, Week 36, Week 48
Change from Baseline on Early Start Denver Model Curriculum Checklist (ESDM-CC)
Time Frame: Baseline, Week 12, Week 24, Week 36, Week 48
A clinician-rated assessment used to measure a child's developmental skills across multiple areas, including communication, social interaction, play, and cognitive abilities. Scores reflect skills gained across developmental domains over time.
Baseline, Week 12, Week 24, Week 36, Week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

John and Marcia Goldman Foundation

Investigators

  • Principal Investigator: Grace Gengoux, PhD, Stanford University
  • Principal Investigator: Antonio Hardan, MD, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

January 1, 2037

Study Completion (Estimated)

January 1, 2037

Study Registration Dates

First Submitted

April 3, 2026

First Submitted That Met QC Criteria

April 3, 2026

First Posted (Actual)

April 13, 2026

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-84604

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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