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Trial of Center-Based vs. In-Home Pivotal Response Treatment (PRT) in Autism
Recruiting
I'm InterestedTrial ID: NCT04899544
Purpose
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 communication deficits in young children with autism spectrum disorder (ASD) with
significant language delay. The two groups will also be compared to a control group that
consists of children who are receiving treatment as usual (TAU).
Official Title
Randomized Controlled Trial of Center-Based vs. In-Home Pivotal Response Treatment (PRT) in Autism
Stanford Investigator(s)
Antonio Hardan, M.D.
Professor of Psychiatry and Behavioral Sciences
Eligibility
Inclusion Criteria:
- 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 who can consistently participate in parent
training and research measures.
Exclusion Criteria:
- 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.
Intervention(s):
behavioral: Center-Based Pivotal Response Treatment (PRT) Intervention (PRT-C)
behavioral: Home-Based Pivotal Response Treatment (PRT Intervention (PRT-H)
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Maddy Clark
650-736-1235