<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01684670</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00039730</org_study_id>
    <nct_id>NCT01684670</nct_id>
  </id_info>
  <brief_title>Intensive Dysarthria Sessions in Adults and Children With Down Syndrome</brief_title>
  <official_title>Intensive Dysarthria Sessions in Adults and Children With Down Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Rhode Island</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research study is designed to investigate the feasibility and treatment effects of a&#xD;
      behavioral speech treatment in adults and children with Down Syndrome (DS) and dysarthria.&#xD;
      The speech sessions will provide an intensive, articulation-based intervention focused on&#xD;
      increasing effort during speech production via use of &quot;clear speech.&quot; A single subject&#xD;
      multiple baselines across subjects design will be employed in a total of six subjects divided&#xD;
      into two groups of three. Changes in dependent measures will be determined by visual&#xD;
      inspection, effect size determination, and time series analysis. The study follows accepted&#xD;
      procedures in rehabilitation treatment and research and there are minimal foreseeable risks&#xD;
      associated with participation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2014</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Speech intelligibility</measure>
    <time_frame>3-6 months</time_frame>
    <description>Speech intelligibility in sentences scored by naive listeners.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Dysarthria</condition>
  <condition>Down Syndrome</condition>
  <arm_group>
    <arm_group_label>Behavioral speech treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Speech sessions</intervention_name>
    <description>Subjects will be instructed to use clear speech and increased effort when speaking.</description>
    <arm_group_label>Behavioral speech treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults and children with Downs Syndrome and dysarthria&#xD;
&#xD;
          -  Ages 8 years and older&#xD;
&#xD;
          -  Ability to verbally communicate; follow simple commands and/or imitate others; hear&#xD;
             speech at a conversational level; and participate in assessment and speech sessions&#xD;
             activities&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Additional serious medical problems which prevent meaningful participation in the&#xD;
             study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Harrison N Jones, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke University Health System</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>September 11, 2012</study_first_submitted>
  <study_first_submitted_qc>September 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 13, 2012</study_first_posted>
  <last_update_submitted>November 22, 2016</last_update_submitted>
  <last_update_submitted_qc>November 22, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 23, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Down Syndrome</mesh_term>
    <mesh_term>Dysarthria</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01684670
org study id: Pro00039730
nct id: NCT01684670
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Speech intelligibility
time frame: 3-6 months
description: Speech intelligibility in sentences scored by naive listeners.
arm group label: Behavioral speech treatment
arm group type: Experimental
intervention type: Behavioral
intervention name: Speech sessions
description: Subjects will be instructed to use clear speech and increased effort when speaking.
arm group label: Behavioral speech treatment
criteria: 
gender: All
minimum age: 8 Years
maximum age: N/A
healthy volunteers: No
last name: Harrison N Jones, PhD
role: Principal Investigator
affiliation: Duke University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Down Syndrome
mesh term: Dysarthria
mesh term: Syndrome