Status:

ACTIVE_NOT_RECRUITING

A Center Based Study of Pivotal Response Treatment for Preschoolers With Autism

Lead Sponsor:

Stanford University

Collaborating Sponsors:

John & Marcia Goldman Foundation

Conditions:

Autism Spectrum Disorder

Autism

Eligibility:

All Genders

2-3 years

Phase:

NA

Brief Summary

The purpose of this study is to examine the effectiveness of pivotal response training (PRT) in an intensive center-based environment to treat social communication deficits in children with autism spe...

Detailed Description

The purpose of this study is to examine the effectiveness of pivotal response training (PRT) in an intensive center-based preschool environment to treat social communication deficits in children with ...

Eligibility Criteria

Inclusion

  • Diagnosis of Autism Spectrum Disorder (ASD) based on clinical interview and Diagnostic and Statistical Manual, 5th edition (DSM-5) and confirmed using the Autism Diagnostic Interview Revised (ADI-R) and Autism Diagnostic Observation Schedule, 2nd edition (ADOS-2) or Childhood Autism Rating Scale (CARS-2); Diagnostic and Statistical Manual, 5th edition (DSM-5), and expert clinical opinion
  • Boys and girls between 2 years and 3 years and 11 months
  • Ability to participate in the testing procedures to the extent that valid standard scores can be obtained
  • Stable treatment (e.g., applied behavior analysis (ABA), speech therapy, psychotropic medication(s) or biomedical intervention(s) for at least 1 month prior to baseline measurements with no anticipated changes during study participation
  • Developmentally delayed with Mullen Scales of Early Learning (MSEL) or Developmental Profile (DP-4) composite score below 85 (1 Standard Deviation below the mean)
  • Availability of at least one English-speaking parent who can consistently participate in parent training and research measures.

Exclusion

  • 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)
  • Child primary language other than English
  • Previous adequate trial of Pivotal Response Treatment
  • More than 15 hours per week of in-home applied behavior analysis (ABA).

Key Trial Info

Start Date :

May 13 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2026

Estimated Enrollment :

75 Patients enrolled

Trial Details

Trial ID

NCT03778827

Start Date

May 13 2019

End Date

June 1 2026

Last Update

November 25 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Stanford University School of Medicine

Stanford, California, United States, 94305