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Pivotal Response Treatment for Individuals With Intellectual Disabilities

Pivotal Response Treatment for Individuals With Intellectual Disabilities

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01988623
Enrollment
21
Registered
2013-11-20
Start date
2012-09-11
Completion date
2017-09-30
Last updated
2021-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intellectual Disabilities, Language Disorder, Speech Delay

Keywords

Intellectual Disabilities, Speech Delay, Language Disorder

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.

Interventions

Sponsors

Stanford University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change from Baseline on the MacArthur-Bates Communication Development Inventory at 6, 12, and 24 weeks6, 12 and 24 weeks
Change from Baseline in communication during parent-child and clinician-child interactions at 6, 12, and 24 weeks6, 12 and 24 weeks
Change from Baseline on the Social Responsiveness Scale (SRS) at 6, 12, and 24 weeks6, 12 and 24 weeks
Change from Baseline on the Clinical Global Impression Scale at 6, 12, and 24 weeks6, 12, and 24 weeks

Secondary

MeasureTime frame
Change from Baseline on the Parenting Stress Index (PSI) at 6, 12, and 24 weeks6, 12, and 24 weeks
Change from Baseline on the Family Empowerment Scale (FES) at 6, 12, and 24 weeks6, 12, and 24 weeks
Change from Baseline on the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at 6, 12, and 24 weeks6, 12 and 24 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026