Status:
ACTIVE_NOT_RECRUITING
A Center Based Study of Pivotal Response Treatment for Preschoolers With Autism
Lead Sponsor:
Stanford University
Collaborating Sponsors:
John & Marcia Goldman Foundation
Conditions:
Autism Spectrum Disorder
Autism
Eligibility:
All Genders
2-3 years
Phase:
NA
Brief Summary
The purpose of this study is to examine the effectiveness of pivotal response training (PRT) in an intensive center-based environment to treat social communication deficits in children with autism spe...
Detailed Description
The purpose of this study is to examine the effectiveness of pivotal response training (PRT) in an intensive center-based preschool environment to treat social communication deficits in children with ...
Eligibility Criteria
Inclusion
- 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 Autism Diagnostic Observation Schedule, 2nd edition (ADOS-2) or Childhood Autism Rating Scale (CARS-2); Diagnostic and Statistical Manual, 5th edition (DSM-5), and expert clinical opinion
- Boys and girls between 2 years and 3 years and 11 months
- Ability to participate in the testing procedures to the extent that valid standard scores can be obtained
- 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
- Developmentally delayed with Mullen Scales of Early Learning (MSEL) or Developmental Profile (DP-4) composite score below 85 (1 Standard Deviation below the mean)
- Availability of at least one English-speaking parent who can consistently participate in parent training and research measures.
Exclusion
- Current or lifetime diagnosis of severe psychiatric disorder (e.g., bipolar disorder, etc.)
- Presence of active medical problem (e.g., unstable seizure disorder or heart disease)
- Child primary language other than English
- Previous adequate trial of Pivotal Response Treatment
- More than 15 hours per week of in-home applied behavior analysis (ABA).
Key Trial Info
Start Date :
May 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2026
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT03778827
Start Date
May 13 2019
End Date
June 1 2026
Last Update
November 25 2025
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305