Status:
RECRUITING
Trial of Center-Based vs. In-Home Pivotal Response Treatment (PRT) in Autism
Lead Sponsor:
Stanford University
Collaborating Sponsors:
Anonymous Donor
Conditions:
Autism
Autism Spectrum Disorder
Eligibility:
All Genders
2-5 years
Phase:
NA
Brief Summary
The aim of this clinical trial is to compare the efficacy of a 16-week center-based Pivotal Response Treatment (PRT-C) versus home-based Pivotal Response Treatment (PRT-H) in targeting social communic...
Eligibility Criteria
Inclusion
- Diagnosis of Autism Spectrum Disorder (ASD) based on Autism Diagnostic Interview Revised (ADI-R), Autism Diagnostic Observation Schedule, Second Edition (ADOS-2) or Childhood Autism Rating Scale, Second Edition (CARS-2), Diagnostic and Statistical Manual 5th Edition (DSM-5), and expert clinical opinion;
- Boys and girls between 2.0 and 5.11 years;
- Ability to participate in the testing procedures to the extent that valid standard scores can be obtained;
- Language delay as measured by the Preschool Language Scale, 5th Edition (PLS-5): Standard score at least 1 standard deviation below average for expressive language ability for 2 and 3 year olds; 2 standard deviations for 4 year olds, and 3 standard deviations for 5 year olds;
- Stable treatment (e.g., Applied Behavior Analysis - ABA), speech therapy, school placement, psychotropic medication(s) or biomedical intervention(s) for at least 1 month prior to baseline measurements;
- No anticipated changes on treatment during study participation for Center-Based Pivotal Response Treatment (PRT-C) and In-Home Pivotal Response Treatment (PRT-H);
- No more than 60 minutes of individual 1:1 speech therapy per week;
- Availability of at least one parent or primary caregiver who can consistently participate in parent training and research measures.
Exclusion
- Current or lifetime diagnosis of severe psychiatric disorder (e.g., bipolar disorder, etc.);
- Receiving ABA of 15 hours or more;
- Presence of active medical problem (e.g., unstable seizure disorder or heart disease);
- Previous adequate Pivotal Response Treatment (PRT) trial;
- Participants living more than 30 miles from Stanford University;
- Child's primary language other than English.
Key Trial Info
Start Date :
October 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 15 2028
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04899544
Start Date
October 18 2022
End Date
September 15 2028
Last Update
November 17 2025
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305