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Intensive Dysarthria Sessions in Adults and Children With Down Syndrome

This study is not yet open for participant recruitment.
Verified April 2013 by Duke University
Sponsor:
Collaborators:
University of Rhode Island
University of Florida
University of North Carolina, Chapel Hill
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01684670
First received: September 11, 2012
Last updated: April 15, 2013
Last verified: April 2013
History of Changes
  Purpose

This research study is designed to investigate the feasibility and treatment effects of a behavioral speech treatment in adults and children with Down Syndrome (DS) and dysarthria. The speech sessions will provide an intensive, articulation-based intervention focused on increasing effort during speech production via use of "clear speech." A single subject multiple baselines across subjects design will be employed in a total of six subjects divided into two groups of three. Changes in dependent measures will be determined by visual inspection, effect size determination, and time series analysis. The study follows accepted procedures in rehabilitation treatment and research and there are minimal foreseeable risks associated with participation.


Condition Intervention
Dysarthria
Down Syndrome
 Behavioral: Speech sessions

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intensive Dysarthria Sessions in Adults and Children With Down Syndrome

Resource links provided by NLM:

MedlinePlus related topics: Down Syndrome
U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Speech intelligibility [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]
    Speech intelligibility in sentences scored by naive listeners.


Estimated Enrollment: 12
Study Start Date: August 2013
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Behavioral speech treatment Behavioral: Speech sessions
Subjects will be instructed to use clear speech and increased effort when speaking.

  Eligibility

Ages Eligible for Study:   8 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: 6 adults and 6 children, ages 8 and older, with DS and dysarthria. In addition, subjects will demonstrate the ability to verbally communicate; follow simple commands and/or imitate others; hear speech at a conversational level; and participate in assessment and speech sessions activities.

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Exclusion Criteria: additional serious medical problems which prevent meaningful participation in the study.

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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01684670

Contacts
Contact: Harrison N Jones, PhD 919-681-1852 harrison.jones@duke.edu

Locations
United States, North Carolina
Duke University Health System Not yet recruiting
Durham, North Carolina, United States, 27710
Principal Investigator: Harrison N Jones, PhD            
Sponsors and Collaborators
Duke University
University of Rhode Island
University of Florida
University of North Carolina, Chapel Hill
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01684670     History of Changes
Other Study ID Numbers: Pro00039730
Study First Received: September 11, 2012
Last Updated: April 15, 2013
Health Authority: United States: Instituitional Review Board

Additional relevant MeSH terms:
Down Syndrome
Dysarthria
Mental Retardation
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
 Chromosome Disorders
Genetic Diseases, Inborn
Articulation Disorders
Speech Disorders
Language Disorders
Communication Disorders
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013