An interventional study of Pivotal Response Treatment Program (PRT-P) in Autism Spectrum Disorder and Autism, sponsored by Stanford University. Recruiting at 1 site in United States. Open to participants aged 2 Years to 4 Years. Per ClinicalTrials.gov, last updated 2025-11-10.
Sponsored by Stanford University · Not applicable, Interventional, and Treatment
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).
1,727 studies on the registry are indexed under Autism Spectrum Disorder; 504 are open to participants now.
This study's planned enrollment of 36 is below the median of 52 across 1,371 interventional studies indexed under Autism Spectrum Disorder.
Browse Autism Spectrum Disorder studies →Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: Pivotal Response Treatment Program (PRT-P)
Child continues stable treatments as usual in the community.
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.
Also known as: Pivotal Response Treatment
Change in Number of Child Utterances During a Structured Lab Observation (SLO)
Time frame: Baseline, 16 Weeks
Change on MacArthur-Bates Communication Development Inventory (CDI)
Time frame: Baseline, 16 Weeks
Change on Preschool Language Scale, 5th Edition (PLS-5)
Time frame: Baseline, 16 Weeks
Change on Mullen Scales of Early Learning
Time frame: Baseline, 16 Weeks
Change on Vineland Adaptive Behaviors Scales, 3rd Edition
Time frame: Baseline, 16 Weeks
Change on Clinical Global Impressions Scale (CGI)
Time frame: Baseline, 16 Weeks
Change on the Brief Observation of Social Communication Change (BOSCC) direct child observation assessment
Time frame: Baseline, 16 Weeks
Change on Parent Stress Index (PSI)
Time frame: Baseline, 16 Weeks
Change on Family Empowerment Scale (FES)
Time frame: Baseline, 16 Weeks
Change on General Self Efficacy Scale (GSES)
Time frame: Baseline, 16 Weeks
Plan to share: Yes — We will submit de-identified clinical data to the NIMH Data Archive (NDA) data repository.
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