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Intensive Dysarthria Sessions in Adults and Children With Down Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01684670
Recruitment Status : Completed
First Posted : September 13, 2012
Last Update Posted : November 23, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Dysarthria Down Syndrome Behavioral: Speech sessions

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intensive Dysarthria Sessions in Adults and Children With Down Syndrome
Study Start Date : February 2014
Primary Completion Date : May 2016
Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
Experimental: Behavioral speech treatment Behavioral: Speech sessions
Subjects will be instructed to use clear speech and increased effort when speaking.

Outcome Measures

Primary Outcome Measures :
  1. Speech intelligibility [ Time Frame: 3-6 months ]
    Speech intelligibility in sentences scored by naive listeners.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adults and children with Downs Syndrome and dysarthria
  • Ages 8 years and older
  • 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

Exclusion Criteria:

  • Additional serious medical problems which prevent meaningful participation in the study.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01684670

United States, North Carolina
Duke University Health System
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
University of Rhode Island
University of Florida
University of North Carolina, Chapel Hill
Principal Investigator: Harrison N Jones, PhD Duke University
More Information

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01684670     History of Changes
Other Study ID Numbers: Pro00039730
First Posted: September 13, 2012    Key Record Dates
Last Update Posted: November 23, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Down Syndrome
Pathologic Processes
Intellectual Disability
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