xml: <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/NCT06014879</url>
    </required_header>
    <id_info>
      <org_study_id>H-51765</org_study_id>
      <nct_id>NCT06014879</nct_id>
    </id_info>
    <brief_title>EMPoWER Study - Strengths-based Behavioral Intervention for Youth With Type 1 Diabetes</brief_title>
    <acronym>EMPoWER</acronym>
    <official_title>Strengths-Based Multi-Level Behavioral Intervention to Promote Resilience and Self-Management in Youth With Type 1 Diabetes</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Baylor College of Medicine</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Children's National Research Institute</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Baylor College of Medicine</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        In preparation for the randomized clinical trial of a new behavioral intervention for&#xD;
        preteens with type 1 diabetes and their parents, the study is first enrolling adolescents&#xD;
        with type 1 diabetes to create videos about living well with type 1 diabetes. The videos will&#xD;
        be used in the intervention materials for the randomized clinical trial.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 7, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2027</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2026</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>
      <intervention_model_description>For the first phase of this project, all teen participants will create videos about living well with type 1 diabetes. The videos will be used in the upcoming randomized clinical trial of the new intervention.</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>All video participants will be in a single group, so there will be no masking.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Demographic and Medical Information Questionnaire</measure>
      <time_frame>Baseline</time_frame>
      <description>Only demographic information and limited diabetes treatment information will be collected about participants in the teen videos portion of this study. Participants will complete a brief questionnaire developed by the study team, which will request self-reported information about participant demographics (e.g., race, ethnicity, gender) and medical information (e.g., time since diabetes diagnosis, current treatments).</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Type 1 Diabetes</condition>
    <arm_group>
      <arm_group_label>Teen Videos</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>All participants in the teen video phase of this project will make brief videos about living well with type 1 diabetes. Guidance will be provided about requirements for the videos. Participants may make up to 4 brief videos. The videos will be used in the upcoming clinical trial of the new behavioral intervention.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Teen Videos</intervention_name>
      <description>All participants in the Teen Videos will create videos about living well with diabetes, which will be used in the upcoming clinical trial of a new behavioral intervention.</description>
      <arm_group_label>Teen Videos</arm_group_label>
      <other_name>EMPoWER Teen Videos</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  self-reported type 1 diabetes diagnosis for ≥ 1 year,&#xD;
  &#xD;
            -  age 14-17 at consent,&#xD;
  &#xD;
            -  English fluency,&#xD;
  &#xD;
            -  living in the United States&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  major psychiatric or developmental disorders in youth or parents that would interfere&#xD;
               with capacity for informed consent or participation,&#xD;
  &#xD;
            -  major medical comorbidities that would confound outcomes (e.g., cancer, cystic&#xD;
               fibrosis).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>14 Years</minimum_age>
      <maximum_age>17 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Marisa Hilliard, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Baylor College of Medicine</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Marisa Hilliard, PhD</last_name>
      <phone>832-824-7209</phone>
      <email>marisa.hilliard@bcm.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Baylor College of Medicine</name>
        <address>
          <city>Houston</city>
          <state>Texas</state>
          <zip>77030</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Marisa Hilliard, PhD</last_name>
        <phone>832-824-7209</phone>
        <email>marisa.hilliard@bcm.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Baylor College of Medicine</investigator_affiliation>
      <investigator_full_name>Marisa Hilliard</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Diabetes Mellitus</mesh_term>
      <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Individual participant data will only be available within study team. Participants may be identified by showing face within videos, and participants sign consent form and institutional media release forms.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06014879
  org study id: H-51765
  nct id: NCT06014879
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  In preparation for the randomized clinical trial of a new behavioral intervention for
        preteens with type 1 diabetes and their parents, the study is first enrolling adolescents
        with type 1 diabetes to create videos about living well with type 1 diabetes. The videos will
        be used in the intervention materials for the randomized clinical trial.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: For the first phase of this project, all teen participants will create videos about living well with type 1 diabetes. The videos will be used in the upcoming randomized clinical trial of the new intervention.
  primary purpose: Other
  masking: None (Open Label)
  masking description: All video participants will be in a single group, so there will be no masking.
  measure: Demographic and Medical Information Questionnaire
  time frame: Baseline
  description: Only demographic information and limited diabetes treatment information will be collected about participants in the teen videos portion of this study. Participants will complete a brief questionnaire developed by the study team, which will request self-reported information about participant demographics (e.g., race, ethnicity, gender) and medical information (e.g., time since diabetes diagnosis, current treatments).
  arm group label: Teen Videos
  arm group type: Other
  description: All participants in the teen video phase of this project will make brief videos about living well with type 1 diabetes. Guidance will be provided about requirements for the videos. Participants may make up to 4 brief videos. The videos will be used in the upcoming clinical trial of the new behavioral intervention.
  intervention type: Behavioral
  intervention name: Teen Videos
  description: All participants in the Teen Videos will create videos about living well with diabetes, which will be used in the upcoming clinical trial of a new behavioral intervention.
  arm group label: Teen Videos
  other name: EMPoWER Teen Videos
  criteria: 
  gender: All
  minimum age: 14 Years
  maximum age: 17 Years
  healthy volunteers: No
  last name: Marisa Hilliard, PhD
  role: Principal Investigator
  affiliation: Baylor College of Medicine
  last name: Marisa Hilliard, PhD
  phone: 832-824-7209
  email: marisa.hilliard@bcm.edu
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Baylor College of Medicine
  investigator full name: Marisa Hilliard
  investigator title: Associate Professor
  mesh term: Diabetes Mellitus
  mesh term: Diabetes Mellitus, Type 1
  sharing ipd: No
  ipd description: Individual participant data will only be available within study team. Participants may be identified by showing face within videos, and participants sign consent form and institutional media release forms.