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

Launched by STANFORD UNIVERSITY · May 19, 2021

Keywords

ClinConnect Summary

This clinical trial is exploring two different ways to deliver a therapy called Pivotal Response Treatment (PRT) to help young children with autism spectrum disorder (ASD) who have significant language delays. The study will compare treatment given in a center (PRT-C) to treatment given at home (PRT-H) over 16 weeks. Researchers want to see which method is more effective in improving social communication skills in children. There will also be a control group of children receiving standard treatment to help with comparisons.

To participate, children must be between 2 and 5 years old and have a diagnosis of ASD, along with a language delay. They should be stable in their current treatments for at least a month and have a parent or caregiver who can consistently join in on the study activities. Participants can expect to engage in fun and interactive therapy sessions designed to improve their communication skills, and their progress will be closely monitored throughout the study. This trial is currently looking for volunteers and aims to provide valuable insights into how different settings for therapy can impact young children with ASD.

Gender

ALL

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.