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Recruiting NCT04899544

Trial of Center-Based vs. In-Home Pivotal Response Treatment (PRT) in Autism

Conditions: Autism, Autism Spectrum Disorder, ASD

Sex: All
Ages: 2 Years – 5 Years
Healthy volunteers: No
Phase: NA
Enrollment: 120
Sponsor: Stanford University

Location: Stanford University School of Medicine Stanford California

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 Criteria

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 or primary caregiver 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04899544). StuddyBuddy aggregates publicly available trial information.