Pivotal Response Treatment for Individuals With Intellectual Disabilities
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ClinicalTrials.gov Identifier: NCT01988623 |
Recruitment Status
:
Recruiting
First Posted
: November 20, 2013
Last Update Posted
: February 10, 2017
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Intellectual Disabilities Speech Delay Language Disorder | Behavioral: Pivotal Response Treatment (PRT) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 120 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Pivotal Response Treatment for Individuals With Intellectual Disabilities |
Study Start Date : | December 2012 |
Estimated Primary Completion Date : | December 2018 |
Estimated Study Completion Date : | July 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: Pivotal Response Treatment (PRT) | Behavioral: Pivotal Response Treatment (PRT) |
- 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 ]
- 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 ]

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Ages Eligible for Study: | 2 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Contact: Rachel Schuck, BA | 650-736-1235 | rschuck@stanford.edu | |
Contact: Robin Libove, BS | 650-736-1235 | rlibove@stanford.edu |
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. |
Principal Investigator: | Antonio Y. Hardan, M.D. | Stanford University |
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 Posted: | November 20, 2013 Key Record Dates |
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 |