Trial of Center-Based vs. In-Home Pivotal Response Treatment (PRT) in Autism
Trial ID or NCT#
NCT04899544
Status
RECRUITING
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
Eligibility Criteria
Ages Eligible for Study: 2 Years to 5 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
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.
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
Maddy Clark
650-736-1235
View on ClinicalTrials.gov
