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Clinical Trials/NCT01908686
NCT01908686
Completed
N/A

Pivotal Response Treatment for Children With Autism Spectrum Disorders

Yale University1 site in 1 country40 target enrollmentMay 2012

Overview

Phase
N/A
Intervention
Not specified
Conditions
Autism Spectrum Disorders
Sponsor
Yale University
Enrollment
40
Locations
1
Primary Endpoint
Social Responsiveness Scale (SRS) Total Score
Status
Completed
Last Updated
5 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
May 2012
End Date
March 1, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Inclusion Criteria:
  • Participants will:
  • Fit the age requirement: age 4-35
  • Have been diagnosed previously with an 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
  • Successfully complete an fMRI and EEG scan
  • Full-scale IQ\>50

Exclusion Criteria

  • Exclusion Criteria:
  • Participants may not have:
  • Any metal or electromagnetic implants, including:
  • Cardiac pacemaker
  • Defibrillator
  • Artificial heart valve
  • Aneurysm clip
  • Cochlear implants
  • Neurostimulators
  • History of metal fragments in eyes or skin

Outcomes

Primary Outcomes

Social Responsiveness Scale (SRS) Total Score

Time Frame: 16 weeks

Secondary Outcomes

  • Autism Diagnostic Observation Schedule (ADOS) Comparison Score(16 weeks)
  • Aberrant Behavior Checklist (ABC)(16 weeks)
  • Vineland Domain Scores(16 weeks)
  • Clinical Global Impressions Scale (CGI-I)(16 weeks)
  • Change in Eye Tracking (ET) patterns(16 weeks)
  • Change in neural response to social stimuli using fMRI(16 weeks)

Study Sites (1)

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