Recruiting

PRT vs. In-Home

Sponsor:

Stanford University

Code:

NCT04899544

Conditions

Autism

Autism Spectrum Disorder

ASD

Eligibility Criteria

Sex: All

Age: 2 - 5

Healthy Volunteers: Not accepted

Interventions

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

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

Study Details

Brief 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).

Conditions

Autism

Autism Spectrum Disorder

ASD

Study ID

NCT04899544

Start date

Oct 18, 2022

Status verified date

Jun, 2026

Completion date

Sep 15, 2028

Anticipated

Primary completion date

Sep 15, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 5

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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

Pivotal Response Treatment in autism center.

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

Pivotal Response Treatment in home environment.

Primary outcome measure

  • Change in Number of Child Utterances during the Parent-Child portion of the Structured Lab Observation (SLO). [ Time Frame: Baseline,16 Weeks. ]

Central Contacts and Locations

Central contacts

Maddy Clark

(650)736-1235PALprogram@stanford.edu

Beatrice Begley

(650)736-1235PALprogram@stanford.edu

Locations

Stanford University School of Medicine

Recruiting

Stanford, California, United States, 94305

Contacts

Maddy Clark

(650) 736-1235PALprogram@stanford.edu

Beatrice Begley

(650) 736-1235PALprogram@stanford.edu

Principal Investigator:

Antonio Y Hardan, MD

More Information

Sponsor

Stanford University

Last update posted

Jun 24, 2026

Last verified

Jun, 2026

Keywords

  • pivotal response treatment
  • PRT
  • center based
  • social and communication

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Stanford University on 2026-06-24.