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

Last updated: January 10, 2026
Sponsor: Stanford University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Asperger's Disorder

Autism

Williams Syndrome

Treatment

Center-Based Pivotal Response Treatment (PRT) Intervention (PRT-C)

Home-Based Pivotal Response Treatment (PRT Intervention (PRT-H)

Clinical Study ID

NCT04899544
IRB-61427
  • Ages 2-5
  • All Genders

Study 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

Inclusion Criteria:

  • Diagnosis of Autism Spectrum Disorder (ASD) based on Autism Diagnostic InterviewRevised (ADI-R), Autism Diagnostic Observation Schedule, Second Edition (ADOS-2) orChildhood Autism Rating Scale, Second Edition (CARS-2), Diagnostic and StatisticalManual 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 standardscores 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 languageability for 2 and 3 year olds; 2 standard deviations for 4 year olds, and 3 standarddeviations for 5 year olds;

  • Stable treatment (e.g., Applied Behavior Analysis - ABA), speech therapy, schoolplacement, psychotropic medication(s) or biomedical intervention(s) for at least 1month prior to baseline measurements;

  • No anticipated changes on treatment during study participation for Center-BasedPivotal 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 consistentlyparticipate in parent training and research measures.

Exclusion

Exclusion Criteria:

  • Current or lifetime diagnosis of severe psychiatric disorder (e.g., bipolardisorder, etc.);

  • Receiving ABA of 15 hours or more;

  • Presence of active medical problem (e.g., unstable seizure disorder or heartdisease);

  • Previous adequate Pivotal Response Treatment (PRT) trial;

  • Participants living more than 30 miles from Stanford University;

  • Child's primary language other than English.

Study Design

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: Center-Based Pivotal Response Treatment (PRT) Intervention (PRT-C)
Phase:
Study Start date:
October 18, 2022
Estimated Completion Date:
September 15, 2028

Connect with a study center

  • Stanford University School of Medicine

    Stanford, California 94305
    United States

    Site Not Available

  • Stanford University School of Medicine

    Stanford 5398563, California 5332921 94305
    United States

    Active - Recruiting

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