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Pivotal Response Treatment for Individuals With Intellectual Disabilities

This study is currently recruiting participants.
Verified February 2017 by Antonio Hardan, Stanford University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01988623
First Posted: November 20, 2013
Last Update Posted: February 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Antonio Hardan, Stanford University
  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: Intervention Model: Single Group Assignment
Masking: None (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 Antonio Hardan, 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 ]
  • 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 ]
  • 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 ]

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 ]
  • Change from Baseline on the Parenting Stress Index (PSI) at 6, 12, and 24 weeks [ Time Frame: 6, 12, and 24 weeks ]
  • Change from Baseline on the Family Empowerment Scale (FES) at 6, 12, and 24 weeks [ Time Frame: 6, 12, and 24 weeks ]
Estimated Enrollment: 120
Study Start Date: December 2012
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pivotal Response Treatment (PRT) Behavioral: Pivotal Response Treatment (PRT)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: November 13, 2013
First Posted: November 20, 2013
Last Update Posted: February 10, 2017
Last Verified: February 2017

Keywords provided by Antonio Hardan, 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