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Pivotal Response Treatment for Individuals With Intellectual Disabilities

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Antonio Hardan, Stanford University
ClinicalTrials.gov Identifier:
NCT01988623
First received: November 13, 2013
Last updated: August 12, 2016
Last verified: August 2016
History of Changes
  Purpose
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.

Condition Intervention
Intellectual Disabilities
Speech Delay
Language Disorder
 Behavioral: Pivotal Response Treatment (PRT)

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pivotal Response Treatment for Individuals With Intellectual Disabilities

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Change from Baseline on the MacArthur-Bates Communication Development Inventory at 6, 12, and 24 weeks [ Time Frame: 6, 12 and 24 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change from Baseline on the Social Responsiveness Scale (SRS) at 6, 12, and 24 weeks [ Time Frame: 6, 12 and 24 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline on the Clinical Global Impression Scale at 6, 12, and 24 weeks [ Time Frame: 6, 12, and 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline on the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at 6, 12, and 24 weeks [ Time Frame: 6, 12 and 24 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline on the Parenting Stress Index (PSI) at 6, 12, and 24 weeks [ Time Frame: 6, 12, and 24 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline on the Family Empowerment Scale (FES) at 6, 12, and 24 weeks [ Time Frame: 6, 12, and 24 weeks ] [ Designated as safety issue: No ]
Estimated Enrollment: 120
Study Start Date: December 2012
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pivotal Response Treatment (PRT) Behavioral: Pivotal Response Treatment (PRT)

  Eligibility
Ages Eligible for Study:   2 Years to 17 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria for Individuals with Intellectual Disabilities:

  • Participants will have an age range between 2 and 17.11 years of age inclusive
  • Male or female
  • Diagnosis of an intellectual disability based on the fourth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR), the 10th revision of the International Statistical Classification of Diseases and Related Health Problems (ICD-10), and an expert clinical evaluation
  • have historical evidence of significant abnormal developmental milestones as determined by neurological history
  • care provider that will reliably bring subject to study visits, and is trustworthy to provide accurate accounts of services provided to the subject

Inclusion Criteria for Individuals with Speech Delay/Language Disorder:

  • Participants will have an age range between 2 and 17.11 years of age inclusive
  • Male or female
  • Diagnosis of a speech delay based on the fourth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR), the 10th revision of the International Statistical Classification of Diseases and Related Health Problems (ICD-10), and an expert clinical evaluation
  • Preschool Language scale (PLS) score of at least 1 standard deviations below age level (for children in the age range of 2-6.11)
  • care provider that will reliably bring subject to study visits, and is trustworthy to provide accurate accounts of services provided to the subject

Exclusion Criteria:

  • medically unstable (such as having unstable seizures)
  • primary diagnosis of Autism Spectrum Disorder (ASD) is exclusionary as determined by the investigators
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01988623

Contacts
Contact: Rachel Schuck, BA 650-736-1235 rschuck@stanford.edu
Contact: Robin Libove, BS 650-736-1235 rlibove@stanford.edu

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305-5719
Contact: Rachel Schuck, BA    650-736-1235    rschuck@stanford.edu   
Contact: Robin Libove, BS    650-736-1235    rlibove@stanford.edu   
Principal Investigator: Antonio Y. Hardan, M.D.         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Antonio Y. Hardan, M.D. Stanford University
  More Information

Responsible Party: Antonio Hardan, Professor of Psychiatry and Behavioral Sciences, Stanford University
ClinicalTrials.gov Identifier: NCT01988623     History of Changes
Other Study ID Numbers: IRB-25229 
Study First Received: November 13, 2013
Last Updated: August 12, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
Intellectual Disabilities
Speech Delay
Language Disorder

Additional relevant MeSH terms:
Intellectual Disability
Language Disorders
Language Development Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
 Nervous System Diseases
Signs and Symptoms
Neurodevelopmental Disorders
Mental Disorders
Communication Disorders

ClinicalTrials.gov processed this record on September 30, 2016