Back to resultsPivotal Response Treatment for Individuals With Intellectual Disabilities
Primary Purpose
Intellectual Disabilities, Speech Delay, Language Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pivotal Response Treatment (PRT)
Sponsored by
About this trial
This is an interventional treatment trial for Intellectual Disabilities focused on measuring Intellectual Disabilities, Speech Delay, Language Disorder
Eligibility 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
Sites / Locations
- Stanford University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pivotal Response Treatment (PRT)
Arm Description
Outcomes
Primary Outcome Measures
Change from Baseline on the MacArthur-Bates Communication Development Inventory at 6, 12, and 24 weeks
Change from Baseline in communication during parent-child and clinician-child interactions at 6, 12, and 24 weeks
Change from Baseline on the Social Responsiveness Scale (SRS) at 6, 12, and 24 weeks
Change from Baseline on the Clinical Global Impression Scale at 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
Change from Baseline on the Parenting Stress Index (PSI) at 6, 12, and 24 weeks
Change from Baseline on the Family Empowerment Scale (FES) at 6, 12, and 24 weeks
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01988623
Brief Title
Pivotal Response Treatment for Individuals With Intellectual Disabilities
Official Title
Pivotal Response Treatment for Individuals With Intellectual Disabilities
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
September 11, 2012 (undefined)
Primary Completion Date
September 30, 2017 (Actual)
Study Completion Date
September 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intellectual Disabilities, Speech Delay, Language Disorder
Keywords
Intellectual Disabilities, Speech Delay, Language Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pivotal Response Treatment (PRT)
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Pivotal Response Treatment (PRT)
Primary Outcome Measure Information:
Title
Change from Baseline on the MacArthur-Bates Communication Development Inventory at 6, 12, and 24 weeks
Time Frame
6, 12 and 24 weeks
Title
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
Title
Change from Baseline on the Social Responsiveness Scale (SRS) at 6, 12, and 24 weeks
Time Frame
6, 12 and 24 weeks
Title
Change from Baseline on the Clinical Global Impression Scale at 6, 12, and 24 weeks
Time Frame
6, 12, and 24 weeks
Secondary Outcome Measure Information:
Title
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
Title
Change from Baseline on the Parenting Stress Index (PSI) at 6, 12, and 24 weeks
Time Frame
6, 12, and 24 weeks
Title
Change from Baseline on the Family Empowerment Scale (FES) at 6, 12, and 24 weeks
Time Frame
6, 12, and 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Y. Hardan, M.D.
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5719
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pivotal Response Treatment for Individuals With Intellectual Disabilities
We'll reach out to this number within 24 hrs