Neuroimaging Predictors of Improvement to Pivotal Response Treatment (PRT) in Young Children With Autism

{ "Neuroimaging Predictors of Improvement to Pivotal Response Treatment (PRT) in Young Children With Autism", "This study is looking at how brain imaging might predict which young children with autism spectrum disorder (ASD) will respond best to an intervention called Pivotal Response Treatment Program (PRT-P). PRT-P is a behavioral therapy that involves 16 weekly sessions with parents and children, focusing on language skills. We want to see if we can find \"neuroimaging biomarkers\" (brain activity patterns) that show who will benefit most from this treatment. Children aged 2 to 4 years old with an ASD diagnosis can join. The main goal is to see how much a child's number of spoken words changes during a structured observation after 16 weeks of treatment. The study aims to enroll 36 participants, but its current status is unclear.", "design": "This is an interventional study planning to enroll 36 participants. Participants will be randomly assigned to either receive the PRT-P intervention or be in a delayed treatment group.", "commitments": "If you participate, you would attend 3 parent-only sessions and 13 family sessions with your child, each lasting 60-90 minutes, once a week for 16 weeks.", "compensation": "Not stated in the trial record.", "follow_up": "Your child's progress will be measured at the beginning of the study and again after 16 weeks.", }

Study design: Not specified.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Neuroimaging Predictors of Improvement to Pivotal Response Treatment (PRT) in Young Children With Autism

Recruiting

NAAges 2–4InterventionalTreatment

Stanford University

~36 participants

Updated 2025-11-10 on ClinicalTrials.gov

What's tested:Pivotal Response Treatment Program (PRT-P)

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Change in Number of Child Utterances During a Structured Lab Observation (SLO)

Measured over Baseline, 16 Weeks

Conditions

Autism Spectrum Disorder

Autism

NCT03583684

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

Stanford University
Stanford, Californiastudy coordinator listed
Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

Antonio Hardan, MD · PRINCIPAL_INVESTIGATOR · Stanford University

Who to contact

Estefania Millan, MA

[email protected]

(650) 736-1235

Email the study team

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Eligibility criteria

Inclusion

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.

Exclusion

Current or life-time diagnosis of severe psychiatric disorder (e.g., bipolar disorder),

Genetic abnormality (e.g., Fragile X)

Presence of active medical problem (e.g., unstable seizure disorder),

Receiving more than 15 hours of in home 1:1 Applied Behavior Analysis (ABA) per week

Magnetic Resonance (MR) contraindication (e.g., the presence of ferrous metal), or

Previous adequate Pivotal Response Treatment (PRT) trial.

What this trial measures

Change in Number of Child Utterances During a Structured Lab Observation (SLO)Baseline, 16 Weeks

Trialytics