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

Trial ID or NCT#

NCT04899544

Status

recruiting iconRECRUITING

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:
  1. * 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:
  1. * 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)

Antonio Hardan, M.D.
Antonio Hardan, M.D.
Psychiatrist
Professor of Psychiatry and Behavioral Sciences

Contact us to find out if this trial is right for you.

Contact

Maddy Clark
650-736-1235