Pivotal Response Treatment for Children With Autism Spectrum Disorders (PRT)

August 11, 2020 updated by: Yale University
The purpose of this study is to evaluate the application of an evidence-based, manualized treatment for children with Autism Spectrum Disorder (ASD) (Pivotal Response Treatment, PRT) to children ages four through six years of age with ASD. Specifically, children will be randomly assigned to receive either (1) 10 hours per week of intervention services, including two hours per week of parent education, and eight hours per week of direct clinician-delivered services, or (2) a treatment as usual control. Intervention will focus on enhancing the following developmental skills: expressive and receptive language, play, and social interaction. Outcome measures will address changes in the aforementioned domains during structured observation and standardized assessment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06512
        • Yale Child Study Center - Autism Program

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 35 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Inclusion Criteria:

Participants will:

  1. Fit the age requirement: age 4-35
  2. Have been diagnosed previously with an ASD and meet criteria for ASD when characterized by research team.
  3. Be in good medical health
  4. Be cooperative with testing
  5. English is a language spoken in the family
  6. Successfully complete an fMRI and EEG scan
  7. Full-scale IQ>50

Exclusion Criteria:

  • Exclusion Criteria:

Participants may not have:

  1. Any metal or electromagnetic implants, including:

    1. Cardiac pacemaker
    2. Defibrillator
    3. Artificial heart valve
    4. Aneurysm clip
    5. Cochlear implants
    6. Shrapnel
    7. Neurostimulators
    8. History of metal fragments in eyes or skin
  2. Significant hearing loss or other severe sensory impairment
  3. A fragile health status.
  4. Current use of prescription medications that may affect cognitive processes under study.
  5. A history of significant head trauma or serious brain or psychiatric illness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Waitlist Control
Children in WL will be offered treatment following WL condition.
Active Comparator: Pivotal Response Training
Pivotal Response Training with children ages 4-35 years of age with an Autism Spectrum Disorder diagnosis
Behavioral: Pivotal Response Training
Behavioral intervention for autism
Other Names:
  • Pivotal Response Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Social Responsiveness Scale (SRS) Total Score
Time Frame: 16 weeks
16 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical Global Impressions Scale (CGI-I)
Time Frame: 16 weeks
16 weeks
Autism Diagnostic Observation Schedule (ADOS) Comparison Score
Time Frame: 16 weeks
16 weeks
Aberrant Behavior Checklist (ABC)
Time Frame: 16 weeks
16 weeks
Vineland Domain Scores
Time Frame: 16 weeks
16 weeks
Change in Eye Tracking (ET) patterns
Time Frame: 16 weeks
16 weeks
Change in neural response to social stimuli using fMRI
Time Frame: 16 weeks
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

March 1, 2020

Study Registration Dates

First Submitted

July 22, 2013

First Submitted That Met QC Criteria

July 25, 2013

First Posted (Estimate)

July 26, 2013

Study Record Updates

Last Update Posted (Actual)

August 14, 2020

Last Update Submitted That Met QC Criteria

August 11, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1106008625
  • 2R01NS035193-18 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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