Trial of Center-Based Early Start Denver Model vs. Pivotal Response Treatment in Children With Au… (NCT07522190) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Trial of Center-Based Early Start Denver Model vs. Pivotal Response Treatment in Children With Autism
United States140 participantsStarted 2027-01
Plain-language 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.
Who can participate
Age range
2 Years – 4 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Week 24 Clinical Global Impressions - Improvement (CGI-I)