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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 5
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
Stanford University School of Medicine
RECRUITING
Stanford
Contact Information
Primary
Maddy Clark
mclark11@stanford.edu
(650)736-1235
Backup
Robin Libove
rlibove@stanford.edu
(650)736-1235
Time Frame
Start Date: 2022-10-18
Estimated Completion Date: 2026-09-15
Participants
Target number of participants: 120
Treatments
Experimental: Center-Based Pivotal Response Treatment (PRT) Intervention (PRT-C)
A 16-week center-based PRT intervention (PRT-C) consisting of 12 hours per week including 1 hour of parent training. This intervention targets social communication deficits.
Experimental: Home-Based Pivotal Response Treatment (PRT) Intervention (PRT-H)
A 16-week home-based PRT intervention (PRT-H) consisting of 12 hours per week including 1 hour of parent training. This intervention targets social communication deficits.
No_intervention: Treatment As Usual (TAU)
This is a control group that consists of children who are receiving treatment as usual (TAU) for a 16-week period. These families will be invited to participate in PRT after completing the 16-week TAU phase.
Related Therapeutic Areas
Sponsors
Leads: Stanford University
Collaborators: Anonymous Donor

This content was sourced from clinicaltrials.gov