Pivotal Response Treatment for Individuals With Intellectual Disabilities

NCT ID: NCT01988623

Last Updated: 2021-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-11

Study Completion Date

2017-09-30

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.

Detailed Description

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Conditions

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Intellectual Disabilities Speech Delay Language Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pivotal Response Treatment (PRT)

Group Type EXPERIMENTAL

Pivotal Response Treatment (PRT)

Intervention Type BEHAVIORAL

Interventions

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Pivotal Response Treatment (PRT)

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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


* 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
Minimum Eligible Age

2 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Antonio Hardan

Professor of Psychiatry and Behavioral Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Antonio Y. Hardan, M.D.

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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IRB-25229

Identifier Type: -

Identifier Source: org_study_id

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