Pivotal Response Treatment for Individuals With Intellectual Disabilities

Sponsor

Stanford University (Other)

Overall Status

Completed

CT.gov ID

NCT01988623

Collaborator

(none)

Enrollment

Location

Arm

60.6

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Intellectual Disabilities Speech Delay Language Disorder	Behavioral: Pivotal Response Treatment (PRT)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

21 participants

Allocation:

N/A

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 :

Sep 11, 2012

Actual Primary Completion Date :

Sep 30, 2017

Actual Study Completion Date :

Sep 30, 2017

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Pivotal Response Treatment (PRT)

Behavioral: Pivotal Response Treatment (PRT)

Outcome Measures

Primary Outcome Measures

Change from Baseline on the MacArthur-Bates Communication Development Inventory at 6, 12, and 24 weeks [6, 12 and 24 weeks]
Change from Baseline in communication during parent-child and clinician-child interactions at 6, 12, and 24 weeks [6, 12 and 24 weeks]
Change from Baseline on the Social Responsiveness Scale (SRS) at 6, 12, and 24 weeks [6, 12 and 24 weeks]
Change from Baseline on the Clinical Global Impression Scale at 6, 12, and 24 weeks [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 [6, 12 and 24 weeks]
Change from Baseline on the Parenting Stress Index (PSI) at 6, 12, and 24 weeks [6, 12, and 24 weeks]
Change from Baseline on the Family Empowerment Scale (FES) at 6, 12, and 24 weeks [6, 12, and 24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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