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Behavioral Intervention

Pivotal Response Treatment for Autism (PRT-I Trial)

N/A

Recruiting

Led By Antonio Hardan, MD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of Autism 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

Must not have

Genetic abnormality (e.g., Fragile X)

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is investigating whether neuroimaging can predict which children with ASD will respond best to an evidence-based behavior intervention.

Who is the study for?

This trial is for children aged 2 to just under 5 with Autism Spectrum Disorder (ASD), who speak English, have a language delay, and can complete testing. They should not be getting more than an hour of speech therapy per week or over 15 hours of in-home ABA. Kids with severe psychiatric disorders, genetic abnormalities like Fragile X, active medical issues like unstable seizures, or previous PRT trials cannot join.

What is being tested?

The study tests if brain scans before treatment can predict how well young children with ASD respond to Pivotal Response Treatment (PRT-P), which focuses on improving language skills. Participants are randomly assigned to start PRT-P immediately or after a delay.

What are the potential side effects?

Since this trial involves behavioral intervention and neuroimaging rather than medication, traditional side effects are not applicable. However, there may be discomfort or anxiety associated with the MRI procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with Autism Spectrum Disorder.

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I am between 2 and 4 years old.

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I receive 60 minutes or less of speech therapy weekly.

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My mental health medication or treatment has been stable for at least a month.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a genetic condition like Fragile X.

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I have a medical condition that is not under control, like seizures.

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I am getting over 15 hours of ABA therapy at home weekly.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Pivotal Response Treatment Program (PRT-P)Experimental Treatment1 Intervention

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.

Group II: Delayed Treatment Group (DTG)Active Control1 Intervention

Child continues stable treatments as usual in the community.

0 / 7Eligibility criteria met