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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and week 12
Awards & highlights

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

PRT-C Trial 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.

PRT-C Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean Change from baseline on the Social Responsiveness Scale-2 Total Score at 12 Weeks
Mean change from baseline on the Brief Observation of Communication Change (BOSCC) total score at 12 Weeks
Mean change from baseline on the frequency if the child's functional utterances on the structured lab observation at 12 Weeks
Secondary outcome measures
Mean change from baseline on the MacArthur-Bates Communication Development Inventory at 12 Weeks
Mean change from baseline on the Vineland Adaptive Behavior Scales 3rd Edition Socialization subscale at 12 Weeks

PRT-C 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.

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,393 Previous Clinical Trials
17,341,148 Total Patients Enrolled
33 Trials studying Autism Spectrum Disorder
4,053 Patients Enrolled for Autism Spectrum Disorder
John & Marcia Goldman FoundationUNKNOWN
1 Previous Clinical Trials
75 Total Patients Enrolled
1 Trials studying Autism Spectrum Disorder
75 Patients Enrolled for Autism Spectrum Disorder
Antonio Y. Hardan, MDPrincipal InvestigatorStanford University
8 Previous Clinical Trials
407 Total Patients Enrolled
7 Trials studying Autism Spectrum Disorder
359 Patients Enrolled for Autism Spectrum Disorder

Media Library

Pivotal Response Treatment (PRT-C) (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT03778827 — N/A
Autism Spectrum Disorder Research Study Groups: Intensive Center-Based Pivotal Response Treatment (PRT-C), Delayed Treatment Group (DTG)
Autism Spectrum Disorder Clinical Trial 2023: Pivotal Response Treatment (PRT-C) Highlights & Side Effects. Trial Name: NCT03778827 — N/A
Pivotal Response Treatment (PRT-C) (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03778827 — N/A

Frequently Asked Questions

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

Do I meet the criteria to join this medical research endeavor?

"For this clinical trial, 44 candidates with Autism Spectrum Disorder aged 2-3 are being sought after. Key eligibility criteria include: a DSM-5 based ASD diagnosis confirmed by the ADI-R and/or ADOS-2 or CARS-2; DSMs 5th edition corroboration from an expert clinician; male and female applicants between two years old to three years eleven months; constant therapeutic treatment like ABA, speech therapy or psychotropic medication for at least one month before baseline measurements with no forecasted variations during study participation; ability to take part in testing processes sufficiently enough that valid standard scores can be achieved, and finally"

Answered by AI

How many participants can the clinical trial accommodate?

"Affirmative. According to the data accessible on clinicaltrials.gov, this medical investigation is actively seeking volunteers; it was first posted on May 8th 2019 and modified as recently as February 15th 2022. A total of 44 participants are expected from one trial site."

Answered by AI

Is this clinical investigation currently enrolling subjects?

"Per the information on clinicaltrials.gov, this trial is open for enrollment and was initially posted on May 8th 2019 with its most recent update occurring on February 15th 2022."

Answered by AI

Is this research protocol limited to adults aged 35 or older?

"This medical trial is seeking out pediatric patients between the ages of two and three."

Answered by AI

Who else is applying?

What state do they live in?
Florida
How old are they?
< 18
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Center Based Study of Pivotal Response Treatment for Preschoolers With Autism
Antonio Hardan 2019. "A Center Based Study of Pivotal Response Treatment for Preschoolers With Autism". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03778827.
All > Asd > Autism
~11 spots leftby Dec 2025
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