Pivotal Response Treatment (PRT) Telemedicine | NCT03045263

Studies
Pivotal Response Treatment (PRT) Telemedicine

NCT03045263

Sponsor

Yale University

Status

Completed

Last Update Posted

Jun 26, 2020Actual

Enrollment

7Actual

Phase

Not Applicable

Conditions

Autism Spectrum Disorder

Interventions

Pivotal Response Treatment

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2, 2017Actual

Primary Completion Date

May 3, 2018Actual

Completion Date

May 3, 2018Actual

First Submitted Date

Feb 3, 2017

First Submission Date that Met QC Criteria

Feb 3, 2017

First Posted Date

Feb 7, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 24, 2020

Last Update Posted Date

Jun 26, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

7Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pivotal Response Treatment	Active Comparator	Pivotal Response Training with children ages 3-6 years of age with an Autism Spectrum Disorder diagnosis	Behavioral: Pivotal Response Treatment
Waitlist Control	No Intervention	Children in WL will be offered treatment following WL condition.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pivotal Response Treatment	Behavioral	Behavioral intervention for autism	Pivotal Response Treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Behavioural Intervention Rating Scale (BIRS)		10 weeks

Secondary Outcomes

Measure	Description	Time Frame
Client Credibility Questionnaire (CCQ)		10 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

6 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yale Child Study Center		New Haven	Connecticut	06512	United States

Condition Browse Module

MeSH Terms

ID	Term
D000067877	Autism Spectrum Disorder

Ancestor Terms

ID	Term
D002659	Child Development Disorders, Pervasive
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided