Pivotal Response Treatment Package for Young Children With Autism (PRT-P)

February 21, 2020 updated by: Antonio Hardan, Stanford University
This is a research study examining the effectiveness of a pivotal response treatment package (PRT-P) in targeting language skills in young children with autism.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Researchers at the Stanford University School of Medicine are seeking participants for a research study examining the effectiveness of a pivotal response treatment package (PRT-P) in targeting language skills in young children with autism. Research has demonstrated that behavioral interventions, such as Pivotal Response Training (PRT), lead to improvements in the core symptoms of autism. Researchers have begun to develop strategies to investigate the effectiveness of combining a parent training program teaching parents how to implement PRT with in-home, therapist-implemented treatment. To determine the effectiveness of a PRT-P, it will be compared to a delayed treatment group (DTG) by conducting a randomized controlled 24-week trial. This research will allow us to help in the development of therapeutic approaches that can meet the increasing service demands for families. We hope that investigating interventions that aim to improve core deficits will aid clinicians in providing better care for children with autism.

Study Type

Interventional

Enrollment (Actual)

48

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
    • California
      • Stanford, California, United States, 94305-5719
        • Stanford University School of Medicine

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

2 years to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of Autism Spectrum Disorder (ASD) based on Autism Diagnostic Interview- Revised (ADI-R), Autism Diagnostic Observation Schedule (ADOS-2), and expert clinical opinion
  • Males and females in good medical health 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: Standard score at least 1 Standard Deviation below average for expressive language ability
  • Stable treatment, speech therapy, school placement, psychotropic medication(s) or biomedical intervention(s) for at least 1 month prior to baseline measurements with no anticipated changes during study participation
  • No more than 60 minutes of individual 1:1 speech therapy per week
  • Availability of at least one parent who can consistently participate in parent training and research measures
  • Parents intend on continuing Pivotal Response Treatment Package (PRT-P) for a minimum of 12 weeks
  • Parents must be 18 years of age or older

Exclusion Criteria:

  • Current or lifetime diagnosis of severe psychiatric disorder, such as bipolar disorder
  • Receiving in-home Applied Behavior Analysis (ABA) of 10 hours or more
  • A genetic abnormality, such as Fragile X
  • Presence of active medical problem, such as unstable seizure disorder or heart disease
  • Previous adequate PRT trial
  • Participants living more than 50 miles from Stanford University
  • At least one room of the house must be available to be dedicated to treatment during session times
  • There must be no serious health and safety risks present in the home environment
  • The research team has the right to refuse to perform sessions in-home even if the criteria above are met

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pivotal Response Treatment Package
Pivotal Response Treatment Package (PRT-P)
Behavioral: Pivotal Response Treatment Package (PRT-P)
No Intervention: Delayed Treatment Group
Delayed Treatment Group (DTG)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in communication during parent-child and clinician-child interactions at 6, 12, and 24 weeks
Time Frame: 6, 12 and 24 weeks
6, 12 and 24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline on the MacArthur-Bates Communication Development Inventory at 6, 12, and 24 weeks
Time Frame: 6, 12 and 24 weeks
6, 12 and 24 weeks
Change from Baseline on the Social Responsiveness Scale (SRS) at 6, 12, and 24 weeks
Time Frame: 6, 12 and 24 weeks
6, 12 and 24 weeks
Change from Baseline on the Clinical Global Impression Scale at 6, 12, and 24 weeks
Time Frame: 6, 12, and 24 weeks
6, 12, and 24 weeks
Change from Baseline on the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at 6, 12, and 24 weeks
Time Frame: 6, 12 and 24 weeks
6, 12 and 24 weeks
Change from Baseline on the Parenting Stress Index (PSI) at 6, 12, and 24 weeks
Time Frame: 6, 12, and 24 weeks
6, 12, and 24 weeks
Change from Baseline on the Family Empowerment Scale (FES) at 6, 12, and 24 weeks
Time Frame: 6, 12, and 24 weeks
6, 12, and 24 weeks
Change from Baseline on the Preschool Language Scale, 5th Edition (PLS-5) at 12, and 24 weeks
Time Frame: 12 and 24 weeks
12 and 24 weeks
Change from Baseline on the Sensory Profile Questionnaire at 6, 12, and 24 weeks
Time Frame: 6, 12 and 24 weeks
6, 12 and 24 weeks
Change from Baseline on the Behavior Rating Inventory of Executive Function, Preschool (BRIEF-P) at 6, 12, and 24 weeks
Time Frame: 6, 12 and 24 weeks
6, 12 and 24 weeks
Change from Baseline on the Social attention and word-learning eye tracking task at 12, and 24 weeks
Time Frame: 12, and 24 weeks
12, and 24 weeks

Collaborators and Investigators

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

Sponsor

Stanford University

Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

  • Principal Investigator: Antonio Hardan, M.D., Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

December 4, 2013

Primary Completion (Actual)

July 28, 2017

Study Completion (Actual)

July 28, 2017

Study Registration Dates

First Submitted

January 13, 2014

First Submitted That Met QC Criteria

January 13, 2014

First Posted (Estimate)

January 15, 2014

Study Record Updates

Last Update Posted (Actual)

February 25, 2020

Last Update Submitted That Met QC Criteria

February 21, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-28314
  • R21DC013689 (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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