NCT07522190Not yet recruiting
Trial of Center-Based Early Start Denver Model vs. Pivotal Response Treatment in Children With Autism
Randomized Controlled Trial of Center-Based Early Start Denver Model (ESDM) vs. Pivotal Response Treatment (PRT) in Children With Autism
Source: ClinicalTrials.gov · Last updated 8 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- First submitted
- 3 Apr 2026
- Start date
- Jan 2027
- Primary completion date
- Jan 2037
- Lead sponsor
- Stanford University
- Diseases
- Autism
- NCT number
- NCT07522190
What you commit to
- Study type: Interventional
- Planned participants: 140
- From Jan 2027 to the primary completion date, Jan 2037
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior adequate trial of PRT or ESDM
Other illness
- 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)
Other
- Child's primary language is not English
- 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
Who the study is looking for
- 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
Age in the registry: 2 years to 4 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Stanford University Coordinator of this site? Confirm its status | Palo Alto | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.