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Comparing Early Start Denver Model and Pivotal Response Treatment for Children with Autism

This study is comparing two established early interventions for young children with autism: the Early Start Denver Model (ESDM) and Pivotal Response Treatment (PRT). The goal is to understand which approach is most effective for improving communication skills and which children might benefit most from each. You may be eligible if you have a child aged 2 to 4 years and 11 months with a confirmed autism diagnosis and significant language delay. The study aims to enroll 140 children. Success will be measured by improvements in your child's overall clinical condition over 24 weeks. After completing ESDM or PRT, some children might also be offered home-based Developmental Reciprocity Treatment (DRT). The current status of this study is unclear.

Study design
This is an interventional study comparing two behavioral therapies, ESDM and PRT, with a planned enrollment of 140 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least 48 weeks, with assessments at Baseline, Week 12, Week 24, Week 36, and Week 48.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07522190

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

Not Yet Recruiting
NAAges 2–4InterventionalTreatment
Stanford University
~140 participants
Updated 2026-07-08 on ClinicalTrials.gov
What's tested:Early Start Denver Model (ESDM)Pivotal Response Treatment (PRT)Developmental Reciprocity Treatment (DRT)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Week 24 Clinical Global Impressions - Improvement (CGI-I)
Measured over Baseline, Week 12, Week 24, Week 36, Week 48

Conditions

Autism Spectrum Disorder (ASD)
Autism

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Autism Spectrum Disorder

NCT07522190

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Stanford University

    Palo Alto, Californiastudy coordinator listed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Antonio Hardan, MD · PRINCIPAL_INVESTIGATOR · Stanford University
  • Grace Gengoux, PhD · PRINCIPAL_INVESTIGATOR · Stanford University

Who to contact

Juliya Pattammady, PhD
[email protected]
650-736-1235
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Week 24 Clinical Global Impressions - Improvement (CGI-I)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.