NCT03045263

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 2, 2017

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 3, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 7, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 3, 2018

Completed
Last Updated

June 26, 2020

Status Verified

June 1, 2020

Enrollment Period

1.2 years

First QC Date

February 3, 2017

Last Update Submit

June 24, 2020

Conditions

Autism Spectrum Disorder

Keywords

ASD

Outcome Measures

Primary Outcomes (1)

  • Behavioural Intervention Rating Scale (BIRS)

    10 weeks

Secondary Outcomes (1)

  • Client Credibility Questionnaire (CCQ)

    10 weeks

Study Arms (2)

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

Pivotal Response TreatmentBEHAVIORAL

Behavioral intervention for autism

Also known as: PRT
Pivotal Response Treatment

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale Child Study Center

New Haven, Connecticut, 06512, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2017

First Posted

February 7, 2017

Study Start

February 2, 2017

Primary Completion

May 3, 2018

Study Completion

May 3, 2018

Last Updated

June 26, 2020

Record last verified: 2020-06

Locations

US(1)