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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:
Stanford University
Information provided by (Responsible Party):
Antonio Hardan, Stanford University
ClinicalTrials.gov Identifier:
NCT01988623
First received: November 13, 2013
Last updated: February 8, 2017
Last verified: February 2017
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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:
Genetics Home Reference related topics:
CASK-related intellectual disability
SYNGAP1-related intellectual disability
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| 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
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
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: | February 8, 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 |
ClinicalTrials.gov processed this record on August 23, 2017