Actively Recruiting

Phase Not Applicable
Age: 2Years - 5Years
All Genders
NCT04899544

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

Led by Stanford University · Updated on 2026-01-13

120

Participants Needed

1

Research Sites

308 weeks

Total Duration

On this page

Sponsors

S

Stanford University

Lead Sponsor

A

Anonymous Donor

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 2Years - 5Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Stanford University School of Medicine

Stanford, California, United States, 94305

Actively Recruiting

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Research Team

M

Maddy Clark

CONTACT

R

Robin Libove

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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