NCT03583684Recruiting
Neuroimaging Predictors of Improvement to Pivotal Response Treatment (PRT) in Young Children With Autism
Source: ClinicalTrials.gov · Last updated 5 Nov 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- First submitted
- 13 Jun 2018
- Start date
- 7 Dec 2018
- Primary completion date
- 30 Nov 2027
- Lead sponsor
- Stanford University
- Diseases
- Autism
- NCT number
- NCT03583684
What you commit to
- Study type: Interventional
- Planned participants: 36
- From 7 Dec 2018 to the primary completion date, 30 Nov 2027
- 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
- Receiving more than 15 hours of in home 1:1 Applied Behavior Analysis (ABA) per week
- Previous adequate Pivotal Response Treatment (PRT) trial.
Other illness
- Current or life-time diagnosis of severe psychiatric disorder (e.g., bipolar disorder),
- Presence of active medical problem (e.g., unstable seizure disorder),
Other
- Genetic abnormality (e.g., Fragile X)
- Magnetic Resonance (MR) contraindication (e.g., the presence of ferrous metal), or
Who the study is looking for
- Diagnosis of Autism Spectrum Spectrum Disorder (ASD) based on clinical interview and Diagnostic and Statistical Manual, 5th edition (DSM-5) and confirmed using the Autism Diagnostic Interview Revised (ADI-R) and the Autism Diagnostic Observation Schedule (ADOS) and/or Brief Observation of Symptoms of Autism (BOSA) and/or Childhood Autism Rating Scale- Second Edition (CARS-2).
- Outpatients between 2.0 and 4.11 years of age of either gender,
- Children of all cognitive levels will be included as long as they are able to participate in the testing procedures to the extent that valid standard scores can be obtained
- Language delay as measured by the Preschool Language Scale, 5th Edition (PLS-5) \[at least 1 standard deviation behind for children age 2 and 3 years; and 2 standard deviations behind for children age 4\],
- Stable psychotropic medication(s) or biomedical intervention(s) for at least 1 month prior to baseline measurements with no anticipated changes during study participation,
- Stable treatment \[Applied Behavior Analysis (ABA), Floortime, or other interventions\], speech therapy, and school placement for at least 1 month prior to baseline measurements with no expected changes during study participation,
- No more than 60 minutes of 1:1 speech therapy per week,
- The child's exposure to the English language must be sufficient that administration of standardized tests in English is appropriate for measuring progress,
- The availability of at least one parent who can consistently participate in the training sessions and related activities, and
- Successful completion of baseline brain scan.
Age in the registry: 2 years to 4 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Stanford University Coordinator of this site? Confirm its status | Stanford | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.