- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03045263
Pivotal Response Treatment (PRT) Telemedicine (PRT)
June 24, 2020 updated by: Yale University
Pivotal Response Treatment Telemedicine
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
7
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06512
- Yale Child Study Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 6 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Pivotal Response Treatment
Pivotal Response Training with children ages 3-6 years of age with an Autism Spectrum Disorder diagnosis
|
Behavioral intervention for autism
Other Names:
|
No Intervention: Waitlist Control
Children in WL will be offered treatment following WL condition.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Behavioural Intervention Rating Scale (BIRS)
Time Frame: 10 weeks
|
10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Client Credibility Questionnaire (CCQ)
Time Frame: 10 weeks
|
10 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 2, 2017
Primary Completion (Actual)
May 3, 2018
Study Completion (Actual)
May 3, 2018
Study Registration Dates
First Submitted
February 3, 2017
First Submitted That Met QC Criteria
February 3, 2017
First Posted (Estimate)
February 7, 2017
Study Record Updates
Last Update Posted (Actual)
June 26, 2020
Last Update Submitted That Met QC Criteria
June 24, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1504015664
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Autism Spectrum Disorder
-
Stanford UniversityCalifornia Department of Developmental ServicesRecruitingAutism Spectrum Disorder | Autistic Disorder | Autism | Autism Spectrum Disorders | Autistic Disorders Spectrum | Autistic Spectrum Disorder | Autistic Spectrum DisordersUnited States
-
Hoffmann-La RocheActive, not recruitingAutism Spectrum Disorder (ASD)United States, Canada, Italy, Spain
-
Axial Therapeutics, Inc.Active, not recruitingAutism Spectrum Disorder (ASD)United States, Australia, New Zealand
-
Technion, Israel Institute of TechnologyCompleted
-
Stanford UniversityNational Institute on Deafness and Other Communication Disorders (NIDCD)CompletedAutism | Autism Spectrum Disorder (ASD)United States
-
Corporacion Parc TauliUnknown
-
Institut de Recherches Internationales ServierADIR, a Servier Group companyTerminatedAutism Spectrum Disorder (ASD)Spain, United States, Hungary, Poland, Australia, United Kingdom, Brazil, Czechia, France, Italy, Portugal, Slovakia
-
Florida Gulf Coast UniversityCompletedAutism Spectrum Disorder High-FunctioningUnited States
-
Hospital Universitario Dr. Jose E. GonzalezUnknownAutism | Autism SpectrumMexico
-
National Taiwan University HospitalCompletedAutism Spectrum Disorder High-FunctioningTaiwan
Clinical Trials on Pivotal Response Treatment
-
Stanford UniversityNational Institute on Deafness and Other Communication Disorders (NIDCD)RecruitingAutism Spectrum Disorder | AutismUnited States
-
Yale UniversityNational Institute of Neurological Disorders and Stroke (NINDS)CompletedAutism Spectrum DisordersUnited States
-
Yale UniversitySimons FoundationCompleted
-
Stanford UniversityRecruitingAutism Spectrum DisorderUnited States
-
Virginia Polytechnic Institute and State UniversityCompletedAutism Spectrum DisorderUnited States
-
Stanford UniversityCompletedIntellectual Disabilities | Speech Delay | Language DisorderUnited States
-
Stanford UniversityNational Institute on Deafness and Other Communication Disorders (NIDCD)CompletedAutism | Autism Spectrum Disorder (ASD)United States
-
Stanford UniversityAnonymous DonorRecruitingAutism Spectrum Disorder | Autism | ASDUnited States
-
Stanford UniversityCompletedSocial Motivation Intervention for Children With Autism Spectrum Disorder: Improving Peer InitiationAutism Spectrum DisorderUnited States
-
Yale UniversityNational Institute of Mental Health (NIMH)CompletedAutism Spectrum DisordersUnited States