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/NCT06018389</url>
    </required_header>
    <id_info>
      <org_study_id>voresvalg_40833</org_study_id>
      <secondary_id>2022-0367531 seqno. 3073</secondary_id>
      <secondary_id>ID: 155933</secondary_id>
      <nct_id>NCT06018389</nct_id>
    </id_info>
    <brief_title>Prevention of Hazardous Use of Alcohol With Danish High School Students (Our Choice)</brief_title>
    <official_title>Prevention of Hazardous Use of Alcohol Among High School Students in Denmark: A Cluster Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Aarhus</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Aarhus</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 trial 'Our Choice' examines the effect of two prevention interventions targeting school,&#xD;
        parent, and student levels at Danish high schools. The interventions aim to reduce hazardous&#xD;
        use of alcohol and related health outcomes among first-year students in Denmark (ages 15-18).&#xD;
        The investigators hypothesizes that a structural intervention (school and parent levels)&#xD;
        reduces hazardous alcohol use and related health outcomes compared to an assessment-only&#xD;
        control group 12 months post baseline; and that adding group-based Motivational Interviewing&#xD;
        (group MI) yields further improvements. Additionally, factors related to the implementation&#xD;
        of the interventions are examined.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The main aim of the 'Our Choice' cluster randomized controlled multisite trial is to test the&#xD;
        efficacy of interventions aimed at reducing hazardous use of alcohol and related health&#xD;
        outcomes among first-year students (15-18 years) in high schools in Denmark. Furthermore, the&#xD;
        aim is to examine feasibility and acceptability of the interventions with Danish students in&#xD;
        high school, as well as with staff (e.g., teachers and principals) to inform future&#xD;
        implementation studies.&#xD;
  &#xD;
        The study employs a parallel group cluster randomized controlled trial design with three&#xD;
        conditions:&#xD;
  &#xD;
          1. Structural condition targeting school and parent levels via school policies for&#xD;
             school-based social events and an information-based interactive parent meeting.&#xD;
  &#xD;
          2. Structural condition combined with group-based Motivational Interviewing (group MI)&#xD;
             which also targets the student level.&#xD;
  &#xD;
          3. Assessment-only control condition with the same assessments as the other two conditions&#xD;
             and with interventions offered after the last follow-up survey.&#xD;
  &#xD;
        The study hypothesizes that students in the structural condition (school and parent levels)&#xD;
        reduce hazardous alcohol use and related health outcomes compared to students in the&#xD;
        assessment-only control condition 12 months post baseline; and that adding group MI yields&#xD;
        further improvements.&#xD;
  &#xD;
        A participatory approach is used to adapt and develop interventions. Sixteen high schools in&#xD;
        Denmark and N=3100 first-year students enrolled in high school in August 2023 will be&#xD;
        recruited. Data will be collected via online questionnaires pre-interventions (baseline), 2,&#xD;
        6, 9 and 12 months post baseline. The primary outcome will be analyzed with generalized&#xD;
        linear mixed models. Feasibility and acceptability will be assessed via surveys (students)&#xD;
        and interviews (high school staff) to inform future implementation.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">August 9, 2023</start_date>
    <completion_date type="Anticipated">January 2027</completion_date>
    <primary_completion_date type="Anticipated">December 2024</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>
      <intervention_model_description>The study employs a parallel group cluster randomized controlled trial design with three conditions: 1) structural condition targeting school and parent levels, 2) structural condition combined with group MI which also targets the student level, and 3) assessment-only control condition (interventions offered after the last follow-up survey).</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Past month high-intensity drinking</measure>
      <time_frame>From baseline to 12 months after baseline</time_frame>
      <description>Past month high-intensity drinking: peak drinks per drinking event, assessed with the Timeline FollowBack (TLFB) (count measure)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Past month alcohol-related consequences</measure>
      <time_frame>From baseline to 12 months after baseline</time_frame>
      <description>Assessed by 21 items covering physical, social and mental issues related to hazardous use of alcohol, developed by the team for Danish youth based on single items from previous Danish surveys and the Rutgers Alcohol Problems Index e.g. black-outs, (emotional) hangovers), sexual contact that was later regretted, with yes/no response options (summed score: range 0-21) with higher scores indicating more negative consequences.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Past month heavy episodic drinking events</measure>
      <time_frame>From baseline to 12 months after baseline</time_frame>
      <description>Past month heavy episodic drinking events assessed by TLFB (count measure).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Well-being in class</measure>
      <time_frame>From baseline to 12 months after baseline</time_frame>
      <description>Assessed by six items rated on a five-point scale from 'completely disagree' to 'completely agree' e.g., I feel accepted by the others in my class (summed score: range 0-30) with a score of 30 representing the best possible well-being in class.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>World Health Organization Five Well-being Index (WHO-5)</measure>
      <time_frame>From baseline to 12 months after baseline</time_frame>
      <description>Psychological well-being, assessed by The World Health Organization Five Well-being Index (summed score: range 0-25) with a score of 25 representing the best possible quality of life.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Past month use of tobacco</measure>
      <time_frame>From baseline to 12 months after baseline</time_frame>
      <description>Measured by days using tobacco (count measure: range 0-30 days)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Past month use of illegal substances</measure>
      <time_frame>From baseline to 12 months after baseline</time_frame>
      <description>Measured by days using cannabis, cocaine, and other illegal drugs (count measure: range 0-30 days).</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">3100</enrollment>
    <condition>Healthy Participants</condition>
    <arm_group>
      <arm_group_label>Structural Only</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The Structural Only condition consists of (1) school policies for school-based social events; and (2) an information-based interactive parent meeting. Interventions in this arm are targeting the school and parent level.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Structural+Group MI</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The Structural+Group MI condition consists of the elements described in &quot;Structural Only&quot; and group MI. Interventions in this arm are targeting all three levels: school, parent and student level.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The Control condition is an assessment-only condition. During the period under study, it includes the same assessments (surveys) as the other two conditions. After the last follow-up (August 2024), control schools can opt-in to receive any of the intervention programs.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Structural only</intervention_name>
      <description>A shared list of school policies for or related to, school-based social events at school premises. The policy initiatives include (but are not limited to): increasing the number of social events without alcohol; promoting non-alcoholic beverages at parties; working with student associations regarding their roles and responsibilities; encouraging parental involvement at school events and disseminating the schools' alcohol policy among students and parents. The school principal and management will be responsible for the implementation and enforcement of the policies.&#xD;
  The Information-based interactive parent meetings will be 45 minutes and will take place at the schools. Parents will be offered concrete, research-informed advice about how they can reduce risk of hazardous substance use and promote well-being among their adolescents. Following a 15-minute presentation, the group leader facilitates a discussion and exchange of experience between parents.</description>
      <arm_group_label>Structural Only</arm_group_label>
      <arm_group_label>Structural+Group MI</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Structural+Group MI</intervention_name>
      <description>Within school classes, students are divided into groups of 5-8 students and each group will be assigned a group leader from the research team. The group-based Motivational Interviewing (group MI) is manualized and consists of two one-hour group sessions administered over two consecutive weeks. The first session is focused on &quot;Tell your story&quot;, &quot;Gains from not drinking&quot;, and &quot;Social norms.&quot; In the second session, the focus is on &quot;Personal values&quot;, &quot;Linking values with behavior&quot; and &quot;Planning/choices regarding alcohol&quot;. Both group MI sessions will take place at the schools during the school day.</description>
      <arm_group_label>Structural+Group MI</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Students starting high school in one of the 16 participating high schools in August&#xD;
               2023&#xD;
  &#xD;
            -  Minimum 15 years old&#xD;
  &#xD;
            -  Understand and speak Danish&#xD;
  &#xD;
            -  Able to give independent informed consent&#xD;
  &#xD;
            -  Staff (school principals, teachers, or administrative employees) from one of the 16&#xD;
               participating high schools&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Under 15 years old&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>15 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Krisrtine Rømer Thomsen</last_name>
      <role>Principal Investigator</role>
      <affiliation>Centre for Alcohol and Drug Research, Aarhus BSS, Aarhus University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Centre for Alcohol and Drug Research, Aarhus BSS, Aarhus University</name>
        <address>
          <city>Aarhus</city>
          <country>Denmark</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Denmark</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Prevention</keyword>
    <keyword>High School</keyword>
    <keyword>Alcohol</keyword>
    <keyword>Substance Use</keyword>
    <keyword>Adolescents</keyword>
    <keyword>Motivational Interviewing</keyword>
    <keyword>School Policies</keyword>
    <keyword>Parents</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>After the conclusion of the study, data from the study will be made available by the Centre for Alcohol and Drug Research, Aarhus University, upon reasonable request, and within the limitations set by the Danish data protection legislation and regulation.</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/NCT06018389
  org study id: voresvalg_40833
  secondary id: 2022-0367531 seqno. 3073
  secondary id: ID: 155933
  nct id: NCT06018389
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The trial 'Our Choice' examines the effect of two prevention interventions targeting school,
        parent, and student levels at Danish high schools. The interventions aim to reduce hazardous
        use of alcohol and related health outcomes among first-year students in Denmark (ages 15-18).
        The investigators hypothesizes that a structural intervention (school and parent levels)
        reduces hazardous alcohol use and related health outcomes compared to an assessment-only
        control group 12 months post baseline; and that adding group-based Motivational Interviewing
        (group MI) yields further improvements. Additionally, factors related to the implementation
        of the interventions are examined.
  The main aim of the 'Our Choice' cluster randomized controlled multisite trial is to test the
        efficacy of interventions aimed at reducing hazardous use of alcohol and related health
        outcomes among first-year students (15-18 years) in high schools in Denmark. Furthermore, the
        aim is to examine feasibility and acceptability of the interventions with Danish students in
        high school, as well as with staff (e.g., teachers and principals) to inform future
        implementation studies.
  
        The study employs a parallel group cluster randomized controlled trial design with three
        conditions:
  
          1. Structural condition targeting school and parent levels via school policies for
             school-based social events and an information-based interactive parent meeting.
  
          2. Structural condition combined with group-based Motivational Interviewing (group MI)
             which also targets the student level.
  
          3. Assessment-only control condition with the same assessments as the other two conditions
             and with interventions offered after the last follow-up survey.
  
        The study hypothesizes that students in the structural condition (school and parent levels)
        reduce hazardous alcohol use and related health outcomes compared to students in the
        assessment-only control condition 12 months post baseline; and that adding group MI yields
        further improvements.
  
        A participatory approach is used to adapt and develop interventions. Sixteen high schools in
        Denmark and N=3100 first-year students enrolled in high school in August 2023 will be
        recruited. Data will be collected via online questionnaires pre-interventions (baseline), 2,
        6, 9 and 12 months post baseline. The primary outcome will be analyzed with generalized
        linear mixed models. Feasibility and acceptability will be assessed via surveys (students)
        and interviews (high school staff) to inform future implementation.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: The study employs a parallel group cluster randomized controlled trial design with three conditions: 1) structural condition targeting school and parent levels, 2) structural condition combined with group MI which also targets the student level, and 3) assessment-only control condition (interventions offered after the last follow-up survey).
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Past month high-intensity drinking
  time frame: From baseline to 12 months after baseline
  description: Past month high-intensity drinking: peak drinks per drinking event, assessed with the Timeline FollowBack (TLFB) (count measure)
  measure: Past month alcohol-related consequences
  time frame: From baseline to 12 months after baseline
  description: Assessed by 21 items covering physical, social and mental issues related to hazardous use of alcohol, developed by the team for Danish youth based on single items from previous Danish surveys and the Rutgers Alcohol Problems Index e.g. black-outs, (emotional) hangovers), sexual contact that was later regretted, with yes/no response options (summed score: range 0-21) with higher scores indicating more negative consequences.
  measure: Past month heavy episodic drinking events
  time frame: From baseline to 12 months after baseline
  description: Past month heavy episodic drinking events assessed by TLFB (count measure).
  measure: Well-being in class
  time frame: From baseline to 12 months after baseline
  description: Assessed by six items rated on a five-point scale from 'completely disagree' to 'completely agree' e.g., I feel accepted by the others in my class (summed score: range 0-30) with a score of 30 representing the best possible well-being in class.
  measure: World Health Organization Five Well-being Index (WHO-5)
  time frame: From baseline to 12 months after baseline
  description: Psychological well-being, assessed by The World Health Organization Five Well-being Index (summed score: range 0-25) with a score of 25 representing the best possible quality of life.
  measure: Past month use of tobacco
  time frame: From baseline to 12 months after baseline
  description: Measured by days using tobacco (count measure: range 0-30 days)
  measure: Past month use of illegal substances
  time frame: From baseline to 12 months after baseline
  description: Measured by days using cannabis, cocaine, and other illegal drugs (count measure: range 0-30 days).
  arm group label: Structural Only
  arm group type: Experimental
  description: The Structural Only condition consists of (1) school policies for school-based social events; and (2) an information-based interactive parent meeting. Interventions in this arm are targeting the school and parent level.
  arm group label: Structural+Group MI
  arm group type: Experimental
  description: The Structural+Group MI condition consists of the elements described in "Structural Only" and group MI. Interventions in this arm are targeting all three levels: school, parent and student level.
  arm group label: Control
  arm group type: No Intervention
  description: The Control condition is an assessment-only condition. During the period under study, it includes the same assessments (surveys) as the other two conditions. After the last follow-up (August 2024), control schools can opt-in to receive any of the intervention programs.
  intervention type: Behavioral
  intervention name: Structural only
  description: A shared list of school policies for or related to, school-based social events at school premises. The policy initiatives include (but are not limited to): increasing the number of social events without alcohol; promoting non-alcoholic beverages at parties; working with student associations regarding their roles and responsibilities; encouraging parental involvement at school events and disseminating the schools' alcohol policy among students and parents. The school principal and management will be responsible for the implementation and enforcement of the policies.
  The Information-based interactive parent meetings will be 45 minutes and will take place at the schools. Parents will be offered concrete, research-informed advice about how they can reduce risk of hazardous substance use and promote well-being among their adolescents. Following a 15-minute presentation, the group leader facilitates a discussion and exchange of experience between parents.
  arm group label: Structural Only
  arm group label: Structural+Group MI
  intervention type: Behavioral
  intervention name: Structural+Group MI
  description: Within school classes, students are divided into groups of 5-8 students and each group will be assigned a group leader from the research team. The group-based Motivational Interviewing (group MI) is manualized and consists of two one-hour group sessions administered over two consecutive weeks. The first session is focused on "Tell your story", "Gains from not drinking", and "Social norms." In the second session, the focus is on "Personal values", "Linking values with behavior" and "Planning/choices regarding alcohol". Both group MI sessions will take place at the schools during the school day.
  arm group label: Structural+Group MI
  criteria: 
  gender: All
  minimum age: 15 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Krisrtine Rømer Thomsen
  role: Principal Investigator
  affiliation: Centre for Alcohol and Drug Research, Aarhus BSS, Aarhus University
  facility: 
  country: Denmark
  responsible party type: Sponsor
  sharing ipd: No
  ipd description: After the conclusion of the study, data from the study will be made available by the Centre for Alcohol and Drug Research, Aarhus University, upon reasonable request, and within the limitations set by the Danish data protection legislation and regulation.