Trial of Center-Based vs. In-Home Pivotal Response Treatment (PRT) in Autism
Randomized Controlled Trial of Center-Based vs. In-Home Pivotal Response Treatment (PRT) in Autism
Stanford University
120 participants
Oct 18, 2022
INTERVENTIONAL
Conditions
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 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).
Eligibility
Inclusion Criteria8
- 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 Criteria6
- 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.
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Interventions
Pivotal Response Treatment in autism center.
Pivotal Response Treatment in home environment.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04899544