Actively Recruiting

Phase Not Applicable
Age: 2Years - 5Years
All Genders
ID04899544

Randomized Controlled 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

N/A

Total Duration

On this page

Sponsors

S

Stanford University

Lead Sponsor

A

Anonymous Donor

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of two types of Pivotal Response Treatment (PRT) to improve social communication in young children with autism spectrum disorder (ASD) who have significant language delays. The study compares a center-based PRT program with a home-based PRT program, and also includes a control group receiving usual treatments. The goal is to see which approach better helps children with ASD develop communication skills. The study involves three groups: one receiving a 16-week center-based PRT (12 hours per week, including 1 hour of parent training), another receiving a 16-week home-based PRT with the same schedule and parent training, and a control group undergoing treatment as usual for 16 weeks. After completing the control phase, families in the control group may be invited to participate in PRT. Participants will be assessed before and after the 16 weeks using various tools to measure changes in child utterances, communication abilities, adaptive behaviors, social responsiveness, and overall social communication. Parents or caregivers will be involved in training and research measures throughout. The study monitors progress through standardized observations, parent ratings, and clinical scales to understand the impact of the different PRT approaches.

CONDITIONS

Brief 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) confirmed by standard diagnostic tools and expert clinical opinion
  • Boys and girls aged between 2.0 and 5.11 years
  • Ability to participate in testing to obtain valid standard scores
  • Language delay measured by Preschool Language Scale with specific thresholds by age
  • Stable treatments such as ABA, speech therapy, psychotropic medications, or biomedical interventions for at least 1 month before baseline
  • No expected changes to treatment during the study for PRT groups
  • No more than 60 minutes of individual speech therapy per week
  • Availability of at least one parent or primary caregiver to participate in training and research
Not Eligible

You will not qualify if you...

  • Current or past diagnosis of severe psychiatric disorders like bipolar disorder
  • Receiving Applied Behavior Analysis (ABA) therapy for 15 hours or more per week
  • Presence of active medical problems such as unstable seizure disorder or heart disease
  • Previous adequate trial of Pivotal Response Treatment (PRT)
  • Living more than 30 miles from Stanford University
  • Child's primary language is not English

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - 16 weeks

Participants receive either center-based or home-based Pivotal Response Treatment (PRT) targeting social communication deficits, or continue with treatment as usual for 16 weeks.

Weekly visits for up to 16 weeks

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

R

Robin Libove

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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