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Clinical Trials/NCT01988623
NCT01988623
Completed
Not Applicable

Pivotal Response Treatment for Individuals With Intellectual Disabilities

Stanford University1 site in 1 country21 target enrollmentSeptember 11, 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intellectual Disabilities
Sponsor
Stanford University
Enrollment
21
Locations
1
Primary Endpoint
Change from Baseline on the Social Responsiveness Scale (SRS) at 6, 12, and 24 weeks
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The investigators will assess the efficacy of Pivotal Response Treatment (PRT) in the treatment of communication deficits in children with intellectual disabilities. By collecting information about parent and child functioning before and after PRT, The investigators will be able to determine whether the intervention is effective in improving child communication and reducing parent stress.

Registry
clinicaltrials.gov
Start Date
September 11, 2012
End Date
September 30, 2017
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Antonio Hardan

Professor of Psychiatry and Behavioral Sciences

Stanford University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • medically unstable (such as having unstable seizures)
  • primary diagnosis of Autism Spectrum Disorder (ASD) is exclusionary as determined by the investigators

Outcomes

Primary Outcomes

Change from Baseline on the Social Responsiveness Scale (SRS) at 6, 12, and 24 weeks

Time Frame: 6, 12 and 24 weeks

Change from Baseline on the Clinical Global Impression Scale at 6, 12, and 24 weeks

Time Frame: 6, 12, and 24 weeks

Change from Baseline on the MacArthur-Bates Communication Development Inventory at 6, 12, and 24 weeks

Time Frame: 6, 12 and 24 weeks

Change from Baseline in communication during parent-child and clinician-child interactions at 6, 12, and 24 weeks

Time Frame: 6, 12 and 24 weeks

Secondary Outcomes

  • Change from Baseline on the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at 6, 12, and 24 weeks(6, 12 and 24 weeks)
  • Change from Baseline on the Parenting Stress Index (PSI) at 6, 12, and 24 weeks(6, 12, and 24 weeks)
  • Change from Baseline on the Family Empowerment Scale (FES) at 6, 12, and 24 weeks(6, 12, and 24 weeks)

Study Sites (1)

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