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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline,16 weeks.
Awards & highlights

PRT-HvC Trial 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.Check my eligibility
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.See study design
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.

PRT-HvC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My child is between 2 and 5 years old.
Select...
I receive 60 minutes or less of speech therapy weekly.

PRT-HvC Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Number of Child Utterances during the Parent-Child portion of the Structured Lab Observation (SLO).
Secondary outcome measures
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
Change From Baseline in Parent Rated Vineland Adaptive Behavior Scale- 3 (VABS-3) Scores
+3 more
Other outcome measures
Change From Baseline in the Parent Rated Behavior Rating Inventory of Executive Function-Preschool (BRIEF-P) Scores
Change From Baseline in the Parent Rated Child and Family Quality of Life - 2 (CFQL-2) Scores
Change From Baseline in the Parent Rated Dimensional Assessment of Repetitive Behaviors (DARB) Scores
+6 more

PRT-HvC 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.

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,378 Previous Clinical Trials
17,333,239 Total Patients Enrolled
Anonymous DonorUNKNOWN
Antonio Y. Hardan, MDPrincipal InvestigatorStanford University
8 Previous Clinical Trials
331 Total Patients Enrolled

Media Library

Center-Based Pivotal Response Treatment (PRT) Intervention (PRT-C) (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04899544 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the protocol for this investigation permit geriatric participants?

"This clinical trial is open to all participants aged between 2 and 5 years old."

Answered by AI

For whom is this research endeavor suitable?

"This medical study is currently recruiting 120 individuals aged between two and five who suffer from Autism Spectrum Disorder. Patients must meet the following criteria in order to be eligible: Diagnostic confirmation of ASD through ADI-R, ADOS-2, CARS-2 or DSM-5; male/female ratio 2.0 - 5.11 years old; no major changes in treatment for 1 month prior to baseline measurements; availability of parent(s) able to consistently participate in training and research measures; capacity to undergo testing procedures with valid standard scores produced; language delay as measured by PLS-5 (Standard score at least 1 STD below"

Answered by AI

What is the scope of participants included in this research?

"Affirmative. The clinicaltrials.gov records demonstrate that this trial is currently recruiting participants; it was first posted on October 18th 2022 and updated recently on the 25th of October 2022. It requires 120 patients from a single clinic for participation."

Answered by AI

Are there vacancies available to participate in this trial?

"Affirmative. Clinicaltrials.gov displays evidence that this medical trial, which initially appeared on October 18th 2022, is still searching for candidates. The study requires 120 participants from a single clinical centre to be enrolled in it."

Answered by AI
~76 spots leftby Sep 2026