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Behavioral Intervention

Pivotal Response Treatment for Autism (PRT-HvC 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

Boys and girls between 2.0 and 5.11 years

No more than 60 minutes of individual 1:1 speech therapy per week

Must not have

Presence of active medical problem

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline,16 weeks.

Awards & highlights

No Placebo-Only Group

Summary

This trial is comparing two different types of therapy for children with autism who have language delays. One group will receive therapy at a center, and the other group will receive therapy at home. There is also a control group who will receive usual treatment.

Who is the study for?

This trial is for young children aged 2 to 5.11 years with autism spectrum disorder (ASD) and a significant language delay, who are receiving no more than an hour of speech therapy per week. They must have stable treatment for at least one month prior and be able to participate in testing procedures. Children with severe psychiatric disorders, unstable medical conditions, or those already having extensive ABA therapy are not eligible.

What is being tested?

The study compares two methods of Pivotal Response Treatment over 16 weeks: one delivered in a center (PRT-C) and the other at home (PRT-H), against usual treatments. It aims to see which setting better improves social communication skills in children with ASD.

What are the potential side effects?

Since Pivotal Response Treatment involves behavioral interventions rather than medication, traditional side effects like you'd expect from drugs aren't applicable here. However, there may be variations in how each child responds to the intensity and setting of the therapy.

Eligibility Criteria

Inclusion Criteria

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

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My child is between 2 and 5 years old.

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I receive 60 minutes or less of speech therapy weekly.

Exclusion Criteria

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

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I have a current health issue that needs treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline,16 weeks.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline,16 weeks.

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline,16 weeks. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Change From Baseline in Parent Rated Social Responsiveness Scale, 2nd Edition (SRS-2) Scores

Change From Baseline in Parent Rated Stanford Social Dimension Scale (SSDS) Scores

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Home-Based Pivotal Response Treatment (PRT) Intervention (PRT-H)Experimental Treatment1 Intervention

A 16-week home-based PRT intervention (PRT-H) consisting of 12 hours per week including 1 hour of parent training. This intervention targets social communication deficits.

Group II: Center-Based Pivotal Response Treatment (PRT) Intervention (PRT-C)Experimental Treatment1 Intervention

A 16-week center-based PRT intervention (PRT-C) consisting of 12 hours per week including 1 hour of parent training. This intervention targets social communication deficits.

Group III: Treatment As Usual (TAU)Active Control1 Intervention

This is a control group that consists of children who are receiving treatment as usual (TAU) for a 16-week period. These families will be invited to participate in PRT after completing the 16-week TAU phase.

0 / 3Eligibility criteria met