Clinical trial NCT01988623: Pivotal Response Treatment for Individuals With Intellectual Disabilities
Official title: Pivotal Response Treatment for Individuals With Intellectual Disabilities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intellectual Disabilities
Speech Delay
Language Disorder
Keywords: Intellectual Disabilities
Speech Delay
Language Disorder
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2013-11-20
Enrollment: 21
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change from Baseline on the MacArthur-Bates Communication Development Inventory at 6, 12, and 24 weeks
timeFrame: 6, 12 and 24 weeks
measure: Change from Baseline in communication during parent-child and clinician-child interactions at 6, 12, and 24 weeks
timeFrame: 6, 12 and 24 weeks
measure: Change from Baseline on the Social Responsiveness Scale (SRS) at 6, 12, and 24 weeks
timeFrame: 6, 12 and 24 weeks
measure: Change from Baseline on the Clinical Global Impression Scale at 6, 12, and 24 weeks
timeFrame: 6, 12, and 24 weeks
Secondary outcomes:
measure: Change from Baseline on the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at 6, 12, and 24 weeks
timeFrame: 6, 12 and 24 weeks
measure: Change from Baseline on the Parenting Stress Index (PSI) at 6, 12, and 24 weeks
timeFrame: 6, 12, and 24 weeks
measure: Change from Baseline on the Family Empowerment Scale (FES) at 6, 12, and 24 weeks
timeFrame: 6, 12, and 24 weeks
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Antonio Y. Hardan, M.D.
role: PRINCIPAL_INVESTIGATOR
References: