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Behavioral Intervention

Pivotal Response Training for Autism (PRT-C Trial)

N/A

Recruiting

Led By Antonio Y. 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

Stable treatment (e.g., applied behavior analysis (ABA), speech therapy, psychotropic medication(s) or biomedical intervention(s) for at least 1 month prior to baseline measurements with no anticipated changes during study participation

Boys and girls between 2 years and 3 years and 11 months

Must not have

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

More than 15 hours per week of in-home applied behavior analysis (ABA).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will study if a treatment called "pivotal response training" can help improve social communication skills in children with autism spectrum disorder.

Who is the study for?

This trial is for preschoolers aged 2 to almost 4 years with Autism Spectrum Disorder (ASD), who have a developmental delay and are English-speaking. They should be on stable treatment without changes expected during the study, and must not have had an adequate trial of Pivotal Response Treatment before.

What is being tested?

The effectiveness of intensive center-based Pivotal Response Training (PRT-C) is being tested to improve social communication in children with ASD. The study will observe how this specific setting influences the progress made by participants.

What are the potential side effects?

Since PRT-C is a behavioral intervention rather than a medication, it does not have traditional side effects. However, there may be variations in behavior or emotional responses as children adjust to the therapy.

Eligibility Criteria

Inclusion Criteria

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

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My current treatment for behavior or speech issues has been stable for at least 1 month.

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My child is between 2 and 3 years and 11 months old.

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I have been diagnosed with Autism Spectrum Disorder by a specialist.

Exclusion Criteria

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

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I have a serious health issue like uncontrolled seizures or heart disease.

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I receive 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: Intensive Center-Based Pivotal Response Treatment (PRT-C)Experimental Treatment1 Intervention

Intensive Center-Based Pivotal Response Treatment (PRT-C) will consist of a combination of one weekly 60-minute individual parent training session and 12 weekly hours ( 3 hours per day for 4 days per week) with the child in center-based therapy environment for a total of 13 weekly treatment hours.

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

Delayed Treatment Group will consist of treatment as usual. At the end of controlled phase, participants in the DTG will be offered PRT-C in a preschool setting in an open-label fashion with a design similar to the double-blind phase.

0 / 5Eligibility criteria met