search
Back to results

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

Primary Purpose

Autism Spectrum Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pivotal Response Training
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorders focused on measuring ASD

Eligibility Criteria

4 Years - 35 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yale Child Study Center - Autism Program

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Pivotal Response Training

Waitlist Control

Arm Description

Pivotal Response Training with children ages 4-35 years of age with an Autism Spectrum Disorder diagnosis

Children in WL will be offered treatment following WL condition.

Outcomes

Primary Outcome Measures

Social Responsiveness Scale (SRS) Total Score

Secondary Outcome Measures

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

Full Information

First Posted
July 22, 2013
Last Updated
August 11, 2020
Sponsor
Yale University
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
search

1. Study Identification

Unique Protocol Identification Number
NCT01908686
Brief Title
Pivotal Response Treatment for Children With Autism Spectrum Disorders
Acronym
PRT
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
March 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorders
Keywords
ASD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pivotal Response Training
Arm Type
Active Comparator
Arm Description
Pivotal Response Training with children ages 4-35 years of age with an Autism Spectrum Disorder diagnosis
Arm Title
Waitlist Control
Arm Type
No Intervention
Arm Description
Children in WL will be offered treatment following WL condition.
Intervention Type
Behavioral
Intervention Name(s)
Pivotal Response Training
Other Intervention Name(s)
Pivotal Response Treatment
Intervention Description
Behavioral intervention for autism
Primary Outcome Measure Information:
Title
Social Responsiveness Scale (SRS) Total Score
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Clinical Global Impressions Scale (CGI-I)
Time Frame
16 weeks
Title
Autism Diagnostic Observation Schedule (ADOS) Comparison Score
Time Frame
16 weeks
Title
Aberrant Behavior Checklist (ABC)
Time Frame
16 weeks
Title
Vineland Domain Scores
Time Frame
16 weeks
Title
Change in Eye Tracking (ET) patterns
Time Frame
16 weeks
Title
Change in neural response to social stimuli using fMRI
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Inclusion Criteria: Participants will: Fit the age requirement: age 4-35 Have been diagnosed previously with an ASD and meet criteria for ASD when characterized by research team. Be in good medical health Be cooperative with testing English is a language spoken in the family Successfully complete an fMRI and EEG scan Full-scale IQ>50 Exclusion Criteria: Exclusion Criteria: Participants may not have: Any metal or electromagnetic implants, including: Cardiac pacemaker Defibrillator Artificial heart valve Aneurysm clip Cochlear implants Shrapnel Neurostimulators History of metal fragments in eyes or skin Significant hearing loss or other severe sensory impairment A fragile health status. Current use of prescription medications that may affect cognitive processes under study. A history of significant head trauma or serious brain or psychiatric illness
Facility Information:
Facility Name
Yale Child Study Center - Autism Program
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06512
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Pivotal Response Treatment for Children With Autism Spectrum Disorders

We'll reach out to this number within 24 hrs