Pivotal Response Treatment for Individuals With Intellectual Disabilities

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Intellectual Disabilities; Speech Delay; Language Disorder	Behavioral: Pivotal Response Treatment (PRT)	Not Applicable

Study Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Primary Outcome Measures :

1. Change from Baseline on the MacArthur-Bates Communication Development Inventory at 6, 12, and 24 weeks [ Time Frame: 6, 12 and 24 weeks ]
2. 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 ]
3. Change from Baseline on the Social Responsiveness Scale (SRS) at 6, 12, and 24 weeks [ Time Frame: 6, 12 and 24 weeks ]
4. 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 :

1. 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 ]
2. Change from Baseline on the Parenting Stress Index (PSI) at 6, 12, and 24 weeks [ Time Frame: 6, 12, and 24 weeks ]
3. Change from Baseline on the Family Empowerment Scale (FES) at 6, 12, and 24 weeks [ Time Frame: 6, 12, and 24 weeks ]

Eligibility Criteria

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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 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