Neuroimaging Predictors of Improvement to Pivotal Response Treatment (PRT) in Young Children With Autism
Part of paid clinical trials in Stanford, California.
- Sponsor
- Stanford University
- Study ID
- NCT03583684
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 2 Years - 4 Years
- Healthy Volunteers
- Not accepted
Interventions
- Pivotal Response Treatment Program (PRT-P) — BEHAVIORALThe Pivotal Response Treatment Program (PRT-P) will consist of 3 parent-only sessions (60-90 min) and 13 family sessions with the parent and child (60-90 min). These 16 sessions are once per week over a 16 week period.
Study Details
Autism spectrum disorder (ASD) is a very heterogeneous disorder with limited empirically validated behavioral and biological interventions. The goal of this pilot investigation is to apply a biologically-based approach to identify predictors of treatment response in children with ASD who are receiving Pivotal Response Treatment (PRT), an evidence-based behavioral intervention. Specifically, the investigators propose to identify neuroimaging biomarkers of treatment response to a PRT program (PRT-P) targeting language deficits in young children with ASD who will be randomized to either PRT-P or to a delayed treatment group (DTG).
Key Dates
- Start date
- Dec 7, 2018
- Status verified
- Nov 2025
- Primary completion
- Nov 30, 2026
- Completion
- Nov 30, 2026
Study Design
- Enrollment
- 36 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Pivotal Response Treatment Program (PRT-P)The Pivotal Response Treatment Program (PRT-P) will consist of 3 parent-only sessions (60-90 min) and 13 family sessions with the parent and child (60-90 min). These 16 sessions are once per week over a 16 week period.
- No Intervention: Delayed Treatment Group (DTG)Child continues stable treatments as usual in the community.
Primary Outcome Measure
Change in Number of Child Utterances During a Structured Lab Observation (SLO) [ Time Frame: Baseline, 16 Weeks ]
Central Contacts
- Estefania Millan, MA(650) 736-1235
- John Hegarty, PhD(650) 736-1235
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Stanford University | Stanford | California | 94305-5719 | Antonio Y. Hardan, MD (PRINCIPAL_INVESTIGATOR) |
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