Pivotal Response Treatment for Individuals With Intellectual Disabilities

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.

Study Overview

• Status: Completed
• Conditions: Intellectual Disabilities; Speech Delay; Language Disorder
• Intervention / Treatment: Behavioral: Pivotal Response Treatment (PRT)

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305-5719
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Antonio Y. Hardan, M.D., Stanford University

Study record dates

Study Major Dates

• Study Start: September 11, 2012
• Primary Completion (Actual): September 30, 2017
• Study Completion (Actual): September 30, 2017

Study Registration Dates

• First Submitted: November 13, 2013
• First Submitted That Met QC Criteria: November 19, 2013
• First Posted (Estimate): November 20, 2013

Study Record Updates

• Last Update Posted (Actual): January 12, 2021
• Last Update Submitted That Met QC Criteria: January 9, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Intellectual Disabilities; Speech Delay; Language Disorder
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Communication Disorders; Intellectual Disability; Language Disorders; Language Development Disorders
• Other Study ID Numbers: IRB-25229