Pivotal Response Treatment for Individuals With Intellectual Disabilities

Study Overview
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Brief Summary
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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.

Official Title
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Pivotal Response Treatment for Individuals With Intellectual Disabilities

Conditions
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Intellectual Disabilities, Speech Delay, Language Disorder

Intervention / Treatment
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* Behavioral: Pivotal Response Treatment (PRT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pivotal Response Treatment (PRT)<br> | Behavioral: Pivotal Response Treatment (PRT)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intellectual Disabilities, Speech Delay, Language Disorder