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

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

PRT-I Trial 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.

PRT-I 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 a Structured Lab Observation (SLO)
Secondary outcome measures
Change on MacArthur-Bates Communication Development Inventory (CDI)
Other outcome measures
Change on Clinical Global Impressions Scale (CGI)
Change on Family Empowerment Scale (FES)
Change on General Self Efficacy Scale (GSES)
+5 more

PRT-I 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.

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,378 Previous Clinical Trials
17,333,327 Total Patients Enrolled
32 Trials studying Autism Spectrum Disorder
4,017 Patients Enrolled for Autism Spectrum Disorder
National Institute on Deafness and Other Communication Disorders (NIDCD)NIH
327 Previous Clinical Trials
178,280 Total Patients Enrolled
10 Trials studying Autism Spectrum Disorder
960 Patients Enrolled for Autism Spectrum Disorder
Antonio Hardan, MDPrincipal Investigator - Stanford University
Lucile Packard Children's Hospital Stanford, Mills-Peninsula Medical Center
St Joseph'S University (Medical School)
University Hlth Ctr Of Pittsburgh (Residency)
8 Previous Clinical Trials
391 Total Patients Enrolled
3 Trials studying Autism Spectrum Disorder
196 Patients Enrolled for Autism Spectrum Disorder

Media Library

Pivotal Response Treatment Program (PRT-P) (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT03583684 — N/A
Autism Spectrum Disorder Research Study Groups: Pivotal Response Treatment Program (PRT-P), Delayed Treatment Group (DTG)
Autism Spectrum Disorder Clinical Trial 2023: Pivotal Response Treatment Program (PRT-P) Highlights & Side Effects. Trial Name: NCT03583684 — N/A
Pivotal Response Treatment Program (PRT-P) (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03583684 — N/A

Frequently Asked Questions

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

Are applicants below the age of fifty-five eligible for this study?

"The target demographic for this clinical trial are individuals aged between 2 and 4 years old."

Answered by AI

Am I able to become a participant in this research?

"This trial is enrolling 36 infants and toddlers aged 2 to 4 years old with autism spectrum disorder. The following conditions should be satisfied for successful enrollment: stable psychotropic or biomedical treatments, no severe language impairment (1 SD below mean at ages 2-3; 2 SDs below the mean at age 4), persistent engagement in ABA/Floortime therapy over a month period prior to baseline measurements, weekly speech therapy of less than 1 hour duration, and active parental involvement throughout the testing procedures."

Answered by AI

Is there still availability for participants in this experiment?

"Affirmative. According to information presented on clinicaltrials.gov, this medical experiment is still accepting participants and was initially posted on December 7th 2018; the most recent update occurred February 15th 2022. 36 individuals are required for participation across 1 site."

Answered by AI
~4 spots leftby Nov 2024