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
About this trial
This is an interventional treatment trial for Autism Spectrum Disorders focused on measuring ASD
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
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
NCT ID
NCT01908686
First Posted
July 22, 2013
Last Updated
August 11, 2020
Sponsor
Yale University
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
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
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Pivotal Response Treatment for Children With Autism Spectrum Disorders
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