Pivotal Response Treatment for Individuals With Intellectual Disabilities

Language Disorder Clinical Trial

Official title:

Pivotal Response Treatment for Individuals With Intellectual Disabilities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01988623
• Other study ID #: IRB-25229
• Status: Completed
• Phase: N/A
• Start date: September 11, 2012
• Est. completion date: September 30, 2017

Study information

• Verified date: January 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 30, 2017
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Intellectual Disabilities
• Intellectual Disability
• Language Development Disorders
• Language Disorder
• Language Disorders
• Speech Delay

Intervention

Behavioral:
• Pivotal Response Treatment (PRT)

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline on the MacArthur-Bates Communication Development Inventory at 6, 12, and 24 weeks		6, 12 and 24 weeks
Primary	Change from Baseline in communication during parent-child and clinician-child interactions at 6, 12, and 24 weeks		6, 12 and 24 weeks
Primary	Change from Baseline on the Social Responsiveness Scale (SRS) at 6, 12, and 24 weeks		6, 12 and 24 weeks
Primary	Change from Baseline on the Clinical Global Impression Scale at 6, 12, and 24 weeks		6, 12, and 24 weeks
Secondary	Change from Baseline on the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at 6, 12, and 24 weeks		6, 12 and 24 weeks
Secondary	Change from Baseline on the Parenting Stress Index (PSI) at 6, 12, and 24 weeks		6, 12, and 24 weeks
Secondary	Change from Baseline on the Family Empowerment Scale (FES) at 6, 12, and 24 weeks		6, 12, and 24 weeks