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/NCT05988931</url>
    </required_header>
    <id_info>
      <org_study_id>HUM00232130</org_study_id>
      <secondary_id>AU-2022C1-25631</secondary_id>
      <nct_id>NCT05988931</nct_id>
    </id_info>
    <brief_title>Technology Interventions for Youth Alcohol Use</brief_title>
    <official_title>Comparing Scalable Technology-Driven Brief Intervention Packages for Youth Alcohol Use</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Michigan</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Patient-Centered Outcomes Research Institute</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Michigan</source>
    <oversight_info>
      <has_dmc>No</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>
        The purpose of this study is to evaluate the effects of two programs to prevent/reduce&#xD;
        alcohol misuse among youth primary care patients. Depending on their study condition, youth&#xD;
        will receive a brief web-based computer program or the web program + 8 weeks of supportive&#xD;
        text messages. Parents/caregivers of youth are encouraged to use a freely available app to&#xD;
        guide conversations with their child about drinking. This study will have significant impact&#xD;
        by evaluating response to these scalable interventions which can be deployed widely in&#xD;
        clinical care settings.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">September 2027</completion_date>
    <primary_completion_date type="Anticipated">September 2027</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>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in Alcohol Consumption</measure>
      <time_frame>3-, 6-, 9- and 12- months post baseline</time_frame>
      <description>Alcohol consumption will be measured using total score on the 3-item Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) which includes typical quantity and frequency, and frequency of binge drinking (# of drinks modified by age based on the NIAAA Youth Guide). Higher score indicates worse outcomes.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in Alcohol Related Consequences</measure>
      <time_frame>3-, 6-, 9- and 12- months post baseline</time_frame>
      <description>Alcohol related consequences will be measured using total score on the brief 18-item version of the Rutgers Alcohol Problem Index (RAPI). Higher score indicates worse outcomes.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Other Drug Use</measure>
      <time_frame>3-, 6-, 9- and 12- months post baseline</time_frame>
      <description>Other drug use will be measured using scores derived from National Survey on Drug Use and Health (NSDUH) survey items for illicit (e.g., cannabis, cocaine, heroin) and prescription (i.e., in any way a doctor did not direct you to use; stimulants, sedatives, and opioids) drugs misuse. Higher scores indicate worse outcomes.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Other Drug Use Consequences</measure>
      <time_frame>3-, 6-, 9- and 12- months post baseline</time_frame>
      <description>Other drug use consequences will be measured using total score on an 18-item version of the drug-focused RAPI. Higher score indicates worse outcomes.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">1400</enrollment>
    <condition>Alcohol Drinking</condition>
    <arm_group>
      <arm_group_label>Web Program + App</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Brief intervention web program (rooted in Motivational Interviewing) recommended at enrollment with parent/caregiver recommended to download and use app (with strategies to talk to youth about drinking prevention).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Web Program + App + Text Messages</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Brief intervention web program (rooted in Motivational Interviewing) recommended at enrollment with parent/caregiver recommended to download and use app (with strategies to talk to youth about drinking prevention) plus youth receive 8 weeks of text messages.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Web Program + App</intervention_name>
      <description>Youth receive a brief interactive web program made available online to prevent alcohol misuse. The parent/caregiver app addresses monitoring and skill building for parents to communicate with the child about preventing underage drinking and drug use.</description>
      <arm_group_label>Web Program + App</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Web Program + App + Text Messages</intervention_name>
      <description>Youth receive a brief interactive web program made available online to prevent alcohol misuse. This is followed by 8 weeks of supportive text messages. The parent/caregiver app addresses monitoring and skill building for parents to communicate with the child about preventing underage drinking and drug use.</description>
      <arm_group_label>Web Program + App + Text Messages</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  patients age 12-17 within the Michigan medicine pediatric care system who had an&#xD;
               appointment date within the past 2 years; and&#xD;
  &#xD;
            -  past 12-month alcohol use; and&#xD;
  &#xD;
            -  patient has a phone that can receive text messages&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  patients who do not understand English; or&#xD;
  &#xD;
            -  patients deemed unable to provide informed consent due to conditions that preclude&#xD;
               understanding of assessment or intervention content; or&#xD;
  &#xD;
            -  parent/guardian consent is not obtained; or&#xD;
  &#xD;
            -  another child in household already enrolled in the study; or&#xD;
  &#xD;
            -  ongoing participation in another behavioral health research study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>12 Years</minimum_age>
      <maximum_age>17 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Maureen Walton, MPH, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Michigan</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Erin Bonar, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Michigan</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Tiffany Wheeler</last_name>
      <email>tiffdw@med.umich.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Meredith Kotov</last_name>
      <email>mphilyaw@med.umich.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of Michigan</name>
        <address>
          <city>Ann Arbor</city>
          <state>Michigan</state>
          <zip>48109</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Tiffany Wheeler</last_name>
      </contact>
      <contact_backup>
        <last_name>Meredith Kotov</last_name>
      </contact_backup>
      <investigator>
        <last_name>Maureen Walton, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Erin Bonar, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Michigan</investigator_affiliation>
      <investigator_full_name>Maureen A Walton</investigator_full_name>
      <investigator_title>Professor of Psychiatry</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Alcohol Drinking</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT05988931
  org study id: HUM00232130
  secondary id: AU-2022C1-25631
  nct id: NCT05988931
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to evaluate the effects of two programs to prevent/reduce
        alcohol misuse among youth primary care patients. Depending on their study condition, youth
        will receive a brief web-based computer program or the web program + 8 weeks of supportive
        text messages. Parents/caregivers of youth are encouraged to use a freely available app to
        guide conversations with their child about drinking. This study will have significant impact
        by evaluating response to these scalable interventions which can be deployed widely in
        clinical care settings.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Change in Alcohol Consumption
  time frame: 3-, 6-, 9- and 12- months post baseline
  description: Alcohol consumption will be measured using total score on the 3-item Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) which includes typical quantity and frequency, and frequency of binge drinking (# of drinks modified by age based on the NIAAA Youth Guide). Higher score indicates worse outcomes.
  measure: Change in Alcohol Related Consequences
  time frame: 3-, 6-, 9- and 12- months post baseline
  description: Alcohol related consequences will be measured using total score on the brief 18-item version of the Rutgers Alcohol Problem Index (RAPI). Higher score indicates worse outcomes.
  measure: Change in Other Drug Use
  time frame: 3-, 6-, 9- and 12- months post baseline
  description: Other drug use will be measured using scores derived from National Survey on Drug Use and Health (NSDUH) survey items for illicit (e.g., cannabis, cocaine, heroin) and prescription (i.e., in any way a doctor did not direct you to use; stimulants, sedatives, and opioids) drugs misuse. Higher scores indicate worse outcomes.
  measure: Change in Other Drug Use Consequences
  time frame: 3-, 6-, 9- and 12- months post baseline
  description: Other drug use consequences will be measured using total score on an 18-item version of the drug-focused RAPI. Higher score indicates worse outcomes.
  arm group label: Web Program + App
  arm group type: Active Comparator
  description: Brief intervention web program (rooted in Motivational Interviewing) recommended at enrollment with parent/caregiver recommended to download and use app (with strategies to talk to youth about drinking prevention).
  arm group label: Web Program + App + Text Messages
  arm group type: Active Comparator
  description: Brief intervention web program (rooted in Motivational Interviewing) recommended at enrollment with parent/caregiver recommended to download and use app (with strategies to talk to youth about drinking prevention) plus youth receive 8 weeks of text messages.
  intervention type: Behavioral
  intervention name: Web Program + App
  description: Youth receive a brief interactive web program made available online to prevent alcohol misuse. The parent/caregiver app addresses monitoring and skill building for parents to communicate with the child about preventing underage drinking and drug use.
  arm group label: Web Program + App
  intervention type: Behavioral
  intervention name: Web Program + App + Text Messages
  description: Youth receive a brief interactive web program made available online to prevent alcohol misuse. This is followed by 8 weeks of supportive text messages. The parent/caregiver app addresses monitoring and skill building for parents to communicate with the child about preventing underage drinking and drug use.
  arm group label: Web Program + App + Text Messages
  criteria: 
  gender: All
  minimum age: 12 Years
  maximum age: 17 Years
  healthy volunteers: No
  last name: Maureen Walton, MPH, PhD
  role: Principal Investigator
  affiliation: University of Michigan
  last name: Erin Bonar, PhD
  role: Principal Investigator
  affiliation: University of Michigan
  last name: Tiffany Wheeler
  email: tiffdw@med.umich.edu
  last name: Meredith Kotov
  email: mphilyaw@med.umich.edu
  facility: 
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of Michigan
  investigator full name: Maureen A Walton
  investigator title: Professor of Psychiatry
  mesh term: Alcohol Drinking
  sharing ipd: No