<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/NCT02998164</url>
  </required_header>
  <id_info>
    <org_study_id>CIN001-Improving Outcomes</org_study_id>
    <nct_id>NCT02998164</nct_id>
  </id_info>
  <brief_title>Improving Outcomes Using Technology for Children Who Are DHH</brief_title>
  <official_title>Improving Outcomes Using Augmentative and Alternative Communication for Children Who Are Deaf or Hard of Hearing</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital Medical Center, Cincinnati</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Children's Hospital Colorado</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Children's Hospital Medical Center, Cincinnati</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the efficacy of using augmentative and alternative communication (AAC)&#xD;
      technology for enhancing language development in children who are deaf or hard of hearing.&#xD;
      Half of the participants will receive AAC technology with their speech and language therapy&#xD;
      and half will continue with their usual care models.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date>October 2016</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Anticipated">September 2025</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Syntax</measure>
    <time_frame>Change between baseline and 24 weeks</time_frame>
    <description>Evaluated using the mean length of utterance in morphemes collected from language samples. Assessing change between baseline and 24 weeks.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>semantics</measure>
    <time_frame>Change between baseline and 24 weeks</time_frame>
    <description>Variety and total number of vocabulary words used collected from language samples.Assessing change between baseline and 24 weeks.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Discourse</measure>
    <time_frame>Assessing change between baseline and 24 weeks.</time_frame>
    <description>Child's mean turn length in words collected from language samples. Assessing change between baseline and 24 weeks.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Language standard scores (receptive and expressive)</measure>
    <time_frame>Assessing change between baseline and 24 weeks.</time_frame>
    <description>Receptive language (what a child understands) and expressive language (what a child says) as measured by standardized language assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social functioning</measure>
    <time_frame>Assessing change between baseline and 24 weeks.</time_frame>
    <description>Social functioning as measured by parent-reported assessments or scales</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">154</enrollment>
  <condition>Hearing Loss</condition>
  <condition>Language Development</condition>
  <condition>Social Behavior</condition>
  <arm_group>
    <arm_group_label>Technology-assisted language intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This intervention will incorporate augmentative and alternative communication software delivered on iPads into speech-language therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>usual care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group will be usual care children are already receiving.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>augmentative and alternative communication technology</intervention_name>
    <arm_group_label>Technology-assisted language intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Usual Care</intervention_name>
    <description>No change to the therapy care received</description>
    <arm_group_label>usual care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  documented permanent bilateral hearing loss with severity levels clinically defined in&#xD;
             any range (mild to profound);&#xD;
&#xD;
          -  identified with a language gap;&#xD;
&#xD;
          -  currently receiving speech-language therapy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  primary language other than English&#xD;
&#xD;
          -  significant motor impairments&#xD;
&#xD;
          -  nonverbal IQ &lt;60&#xD;
&#xD;
          -  children with severe communication disorders (i.e. autism spectrum disorders).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jareen Meinzen-Derr, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Hospital Medical Center, Cincinnati</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Laura Smith, MPH</last_name>
    <phone>513-803-1901</phone>
    <email>laura.smith1@cchmc.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jareen Meinzen-Derr, PhD</last_name>
    <phone>513-636-7789</phone>
    <email>jareen.meinzen-derr@cchmc.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Children's Hospital of Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Deborah Mood, PhD</last_name>
      <phone>720-777-2778</phone>
      <email>Deborah.Mood@childrenscolorado.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Cincinnati Children's Hospital Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jareen Meinzen-Derr, PhD</last_name>
      <phone>513-636-7789</phone>
      <email>jareen.meinzen-derr@cchmc.org</email>
    </contact>
    <contact_backup>
      <last_name>Laura Smith, MPH</last_name>
      <phone>513-803-1901</phone>
      <email>laura.smith1@cchmc.org</email>
    </contact_backup>
    <investigator>
      <last_name>Susan Wiley, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>November 10, 2016</study_first_submitted>
  <study_first_submitted_qc>December 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>January 26, 2023</last_update_submitted>
  <last_update_submitted_qc>January 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 27, 2023</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>Hearing Loss</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>We currently do not have a IPD sharing plan. However, we will have one in place prior to the end of the study</ipd_description>
  </patient_data>
  <!-- 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/NCT02998164
org study id: CIN001-Improving Outcomes
nct id: NCT02998164
lead sponsor: 
collaborator: 
has dmc: No
This study evaluates the efficacy of using augmentative and alternative communication (AAC)
      technology for enhancing language development in children who are deaf or hard of hearing.
      Half of the participants will receive AAC technology with their speech and language therapy
      and half will continue with their usual care models.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Syntax
time frame: Change between baseline and 24 weeks
description: Evaluated using the mean length of utterance in morphemes collected from language samples. Assessing change between baseline and 24 weeks.
measure: semantics
time frame: Change between baseline and 24 weeks
description: Variety and total number of vocabulary words used collected from language samples.Assessing change between baseline and 24 weeks.
measure: Discourse
time frame: Assessing change between baseline and 24 weeks.
description: Child's mean turn length in words collected from language samples. Assessing change between baseline and 24 weeks.
measure: Language standard scores (receptive and expressive)
time frame: Assessing change between baseline and 24 weeks.
description: Receptive language (what a child understands) and expressive language (what a child says) as measured by standardized language assessment.
measure: Social functioning
time frame: Assessing change between baseline and 24 weeks.
description: Social functioning as measured by parent-reported assessments or scales
arm group label: Technology-assisted language intervention
arm group type: Experimental
description: This intervention will incorporate augmentative and alternative communication software delivered on iPads into speech-language therapy
arm group label: usual care
arm group type: Active Comparator
description: This group will be usual care children are already receiving.
intervention type: Behavioral
intervention name: augmentative and alternative communication technology
arm group label: Technology-assisted language intervention
intervention type: Behavioral
intervention name: Usual Care
description: No change to the therapy care received
arm group label: usual care
criteria: 
gender: All
minimum age: 3 Years
maximum age: 10 Years
healthy volunteers: No
last name: Jareen Meinzen-Derr, PhD
role: Principal Investigator
affiliation: Children's Hospital Medical Center, Cincinnati
last name: Laura Smith, MPH
phone: 513-803-1901
email: laura.smith1@cchmc.org
last name: Jareen Meinzen-Derr, PhD
phone: 513-636-7789
email: jareen.meinzen-derr@cchmc.org
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Hearing Loss
sharing ipd: No
ipd description: We currently do not have a IPD sharing plan. However, we will have one in place prior to the end of the study