Pivotal Response Treatment for Children With Autism Spectrum Disorders

Autism Spectrum Disorders Clinical Trial

— PRT  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01908686
• Other study ID #: 1106008625
• Secondary ID: 2R01NS035193-18
• Status: Completed
• Phase: N/A
• Start date: May 2012
• Est. completion date: March 1, 2020

Study information

• Verified date: August 2020
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 1, 2020
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 35 Years

Eligibility

Inclusion Criteria:

• Inclusion Criteria:

Participants will:

1. Fit the age requirement: age 4-35

2. Have been diagnosed previously with an ASD and meet criteria for ASD when characterized by research team.

3. Be in good medical health

4. Be cooperative with testing

5. English is a language spoken in the family

6. Successfully complete an fMRI and EEG scan

7. Full-scale IQ>50

Exclusion Criteria:

• Exclusion Criteria:

Participants may not have:

1. Any metal or electromagnetic implants, including:

1. Cardiac pacemaker

2. Defibrillator

3. Artificial heart valve

4. Aneurysm clip

5. Cochlear implants

6. Shrapnel

7. Neurostimulators

8. History of metal fragments in eyes or skin

2. Significant hearing loss or other severe sensory impairment

3. A fragile health status.

4. Current use of prescription medications that may affect cognitive processes under study.

5. A history of significant head trauma or serious brain or psychiatric illness

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autism Spectrum Disorders

Intervention

Behavioral:
• Pivotal Response Training
Behavioral intervention for autism

Locations

Country	Name	City	State
United States	Yale Child Study Center - Autism Program	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Social Responsiveness Scale (SRS) Total Score		16 weeks
Secondary	Clinical Global Impressions Scale (CGI-I)		16 weeks
Secondary	Autism Diagnostic Observation Schedule (ADOS) Comparison Score		16 weeks
Secondary	Aberrant Behavior Checklist (ABC)		16 weeks
Secondary	Vineland Domain Scores		16 weeks
Secondary	Change in Eye Tracking (ET) patterns		16 weeks
Secondary	Change in neural response to social stimuli using fMRI		16 weeks