NCT01988623

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 11, 2012

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 13, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 20, 2013

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
Last Updated

January 12, 2021

Status Verified

January 1, 2021

Enrollment Period

5.1 years

First QC Date

November 13, 2013

Last Update Submit

January 9, 2021

Conditions

Intellectual DisabilitiesSpeech DelayLanguage Disorder

Keywords

Intellectual DisabilitiesSpeech DelayLanguage Disorder

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (3)

  • 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

Study Arms (1)

Pivotal Response Treatment (PRT)

EXPERIMENTAL
Behavioral: Pivotal Response Treatment (PRT)

Interventions

Pivotal Response Treatment (PRT)BEHAVIORAL
Pivotal Response Treatment (PRT)

Eligibility Criteria

Age2 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • medically unstable (such as having unstable seizures)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305-5719, United States

Location

MeSH Terms

Conditions

Intellectual DisabilityLanguage Development DisordersLanguage Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental DisordersCommunication Disorders

Study Officials

  • Antonio Y. Hardan, M.D.

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry and Behavioral Sciences

Study Record Dates

First Submitted

November 13, 2013

First Posted

November 20, 2013

Study Start

September 11, 2012

Primary Completion

September 30, 2017

Study Completion

September 30, 2017

Last Updated

January 12, 2021

Record last verified: 2021-01

Locations

US(1)