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NCT04899544Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 24 Jun 2026

Brief summary (registry, in English)

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).

Status (registry)
Recruiting
Study type
Interventional
Enrollment
120 (estimated)
First submitted
19 May 2021
Start date
18 Oct 2022
Primary completion date
15 Sept 2028
Lead sponsor
Stanford University
Diseases
Autism
NCT number
NCT04899544

What you commit to

  • Study type: Interventional
  • Planned participants: 120
  • From 18 Oct 2022 to the primary completion date, 15 Sept 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Receiving ABA of 15 hours or more;
  • Previous adequate Pivotal Response Treatment (PRT) trial;

Other illness

  • Current or lifetime diagnosis of severe psychiatric disorder (e.g., bipolar disorder, etc.);
  • Presence of active medical problem (e.g., unstable seizure disorder or heart disease);

Other

  • Participants living more than 30 miles from Stanford University;
  • Child's primary language other than English.

Who the study is looking for

  • 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.

Age in the registry: 2 years to 5 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Stanford University School of Medicine
Coordinator of this site? Confirm its status
StanfordUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.