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OpenTrials
Completed

NCT Number: NCT01988623

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.

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Key information

Conditions

Intellectual Disabilities Communication Disorders Intellectual Disability Language Development Disorders Language Disorder Language Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Speech Delay

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University School of Medicine

Stanford, California, 94305-5719, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pivotal Response Treatment (PRT)

Behavioral

Primary outcomes

  1. Change from Baseline on the MacArthur-Bates Communication Development Inventory at 6, 12, and 24 weeks

    Time frame: 6, 12 and 24 weeks

  2. Change from Baseline in communication during parent-child and clinician-child interactions at 6, 12, and 24 weeks

    Time frame: 6, 12 and 24 weeks

  3. Change from Baseline on the Social Responsiveness Scale (SRS) at 6, 12, and 24 weeks

    Time frame: 6, 12 and 24 weeks

  4. Change from Baseline on the Clinical Global Impression Scale at 6, 12, and 24 weeks

    Time frame: 6, 12, and 24 weeks

Secondary outcomes

  1. Change from Baseline on the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at 6, 12, and 24 weeks

    Time frame: 6, 12 and 24 weeks

  2. Change from Baseline on the Parenting Stress Index (PSI) at 6, 12, and 24 weeks

    Time frame: 6, 12, and 24 weeks

  3. Change from Baseline on the Family Empowerment Scale (FES) at 6, 12, and 24 weeks

    Time frame: 6, 12, and 24 weeks

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Nov 20, 2013
Registry last updated
Jan 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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