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Pivotal Response Treatment (PRT) Telemedicine (PRT)

Primary Purpose

Autism Spectrum Disorder

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

About this trial

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

Eligibility Criteria

3 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Fits age requirement: age 3-6 years
  • Have been diagnosed previously with 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
  • full scale IQ > 70

Exclusion Criteria:

  • significant hearing loss or other severe sensory impairment
  • a fragile health status
  • a history of significant head trauma or serious brain or psychiatric illness

Sites / Locations

  • Yale Child Study Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Pivotal Response Treatment

Waitlist Control

Arm Description

Pivotal Response Training with children ages 3-6 years of age with an Autism Spectrum Disorder diagnosis

Children in WL will be offered treatment following WL condition.

Outcomes

Primary Outcome Measures

Behavioural Intervention Rating Scale (BIRS)

Secondary Outcome Measures

Client Credibility Questionnaire (CCQ)

Full Information

First Posted
February 3, 2017
Last Updated
June 24, 2020
Sponsor
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT03045263
Brief Title
Pivotal Response Treatment (PRT) Telemedicine
Acronym
PRT
Official Title
Pivotal Response Treatment Telemedicine
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
February 2, 2017 (Actual)
Primary Completion Date
May 3, 2018 (Actual)
Study Completion Date
May 3, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the application of a modified version of PRT designed specifically as a parent-training model via telemedicine, with the goal of increasing access to empirically validated care. The project will feature an 18-week trial of parent training PRT via telemedicine in 12 cognitively able 3- to 6-year-old children with ASD. 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.
Detailed Description
The purpose of this study is to evaluate the application of a modified version of PRT designed specifically as a parent-training model via telemedicine, with the goal of increasing access to empirically validated care. The project will feature an 18-week trial of parent training PRT via telemedicine in 12 cognitively able 3- to 6-year-old children with ASD. 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 Disorder
Keywords
ASD

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Pivotal Response Treatment
Arm Type
Active Comparator
Arm Description
Pivotal Response Training with children ages 3-6 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 Treatment
Other Intervention Name(s)
PRT
Intervention Description
Behavioral intervention for autism
Primary Outcome Measure Information:
Title
Behavioural Intervention Rating Scale (BIRS)
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Client Credibility Questionnaire (CCQ)
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Fits age requirement: age 3-6 years Have been diagnosed previously with 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 full scale IQ > 70 Exclusion Criteria: significant hearing loss or other severe sensory impairment a fragile health status a history of significant head trauma or serious brain or psychiatric illness
Facility Information:
Facility Name
Yale Child Study Center
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 (PRT) Telemedicine

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