<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/NCT03288896</url>
  </required_header>
  <id_info>
    <org_study_id>University of Seville. Spain</org_study_id>
    <nct_id>NCT03288896</nct_id>
  </id_info>
  <brief_title>Alerta Alcohol. Web-based Computer-tailored Intervention for Binge-drinking Prevention in Spanish Adolescents</brief_title>
  <official_title>Alerta Alcohol. Design, Implementation, and Evaluation of a Tailored Web-based Computer-tailored Intervention for Selective Prevention of Binge-drinking in Spanish Adolescents.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Seville</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Junta de Andalucía</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Maastricht University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Seville</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>
      This study consists in the the design, implementation, and evaluation of the first web-based&#xD;
      computer tailored intervention program aimed at the prevention of binge drinking in Spanish&#xD;
      adolescents (Alerta Alcohol). A Cluster Randomized Controlled Trial is conducted to test the&#xD;
      effectiveness of Alerta Alcohol in students aged 16 to 18 years across 16 high schools from&#xD;
      Andalusia (southern Spain), which are randomized either to the experimental or the control&#xD;
      condition (EC and CC).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Binge-drinking in adolescents is a highly prevalent healthcare problem that associates&#xD;
      physical and mental health complications and community implications.&#xD;
&#xD;
      The &quot;Alerta Alcohol&quot; program is based on the I-Change Model. Focus and Delphi groups are used&#xD;
      to obtain further information on items included in the program. A pilot study is conducted to&#xD;
      identify strengths and weaknesses. A Cluster Randomized Controlled Trial is carried out. The&#xD;
      schools from Andalusia are randomized either to the experimental or the control condition (EC&#xD;
      and CC). The EC receives the Alerta Alcohol intervention, which consists of four sessions at&#xD;
      school: baseline questionnaire and two sessions where adolescents are provided with answers&#xD;
      related to their views to provide highly specific feedback regarding their knowledge, risk&#xD;
      perception, self-esteem, attitude, social influence, and self-efficacy. In addition, two&#xD;
      booster sessions are given at home to reinforce the contents. The CC just completes the&#xD;
      baseline and the evaluation questionnaires and then they are allowed to receive the&#xD;
      intervention as well (as a waiting list control condition). Evaluation takes place after four&#xD;
      months. The primary endpoint is binge drinking within 30 days prior to evaluation and alcohol&#xD;
      use in the previous week. It is expected that Alerta Alcohol reduces the prevalence of binge&#xD;
      drinking by 10%. Follow up analyses are carried out to determine the differences in&#xD;
      effectiveness according to the compliance of the program (quality of the implementation).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2016</start_date>
  <completion_date type="Actual">June 30, 2017</completion_date>
  <primary_completion_date type="Actual">June 30, 2017</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>A Cluster Randomized Controlled Trial is conducted to test the effectiveness of Alerta Alcohol in students aged 16 to 18 years. The study is performed in 16 high schools from Andalusia (southern Spain), which are randomized either to the experimental or the control condition (EC and CC). The EC receives the Alerta Alcohol intervention, which consists of four sessions at school. The adolescents are provided highly specific feedback regarding their knowledge, risk perception, self-esteem, attitude, social influence, and self-efficacy. In addition, two booster sessions are given at home to reinforce the contents of the three scenarios. The CC just completes the baseline and the evaluation questionnaires and then they are allowed to receive the intervention as well (as a waiting list control condition).</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reducing binge-drinking</measure>
    <time_frame>4 months after the baseline</time_frame>
    <description>Reducing binge-drinking (4/5 glasses or alcohol in one ocassion for a girl/boy) within 30 days prior to evaluation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reducing weekly alcohol drinking</measure>
    <time_frame>4 months after the baseline</time_frame>
    <description>Reducing alcohol drinking within the 7 days prior to evaluation</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1230</enrollment>
  <condition>Alcohol Drinking</condition>
  <condition>Binge Drinking</condition>
  <condition>Adolescent Behavior</condition>
  <arm_group>
    <arm_group_label>Alerta Alcohol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention Group: The Experimental Group receives the Alerta Alcohol intervention, which consists of four sessions at school (baseline questionnaire, two sessions in three scenarios: at home, celebrations, and public places, and a final evaluation). The adolescents are provided with answers related to their views of each scenario; this information is used to provide highly specific feedback regarding their knowledge, risk perception, self-esteem, attitude, social influence (modelling, norms and social pressure), self-efficacy and action plans. In addition, two booster sessions are given at home to reinforce the contents of the three scenarios. Evaluation takes place after four months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control Group: The Control Group just completes the baseline and the evaluation questionnaires and then they are allowed to receive the intervention as well (as a waiting list control condition). Evaluation takes place after four months from baseline</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Alerta Alcohol</intervention_name>
    <description>The intervention consists of preventive messages about the benefits of not consuming alcohol, reducing the positive attitudes and encouraging the negative attitudes towards alcohol drinking and binge drinking, as well as social influence and self-efficacy, by personalized feedback. Skills and action plans are encouraged to help the student to reject binge drinking. This information is presented through different tailored messages. Moreover, four avatars (two males and two females), which can be chosen as part of the story development. This story consists of a short story about the alcohol consumption by adolescents.The stories take place in three different scenarios (at home, at celebrations and in public places).</description>
    <arm_group_label>Alerta Alcohol</arm_group_label>
    <other_name>Alerta Alcohol, a web-based computer-tailored intervention</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Students aged 16 to 18 years.&#xD;
&#xD;
          -  Enrolled in Andalusian public high schools.&#xD;
&#xD;
          -  Schools belonging to provincial capitals.&#xD;
&#xD;
          -  Access to the Internet at the school and an equipped ICT room.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Language barriers.&#xD;
&#xD;
          -  Previous participation in prevention programs for binge drinking.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marta Lima Serrano, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Seville</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Marta Lima Serrano</name>
      <address>
        <city>Sevilla</city>
        <zip>41009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 17, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 20, 2017</study_first_posted>
  <last_update_submitted>September 19, 2017</last_update_submitted>
  <last_update_submitted_qc>September 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Seville</investigator_affiliation>
    <investigator_full_name>Marta Lima Serrano</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>Adolescence</keyword>
  <keyword>Alcohol Drinking</keyword>
  <keyword>Binge Drinking</keyword>
  <keyword>I-Change model</keyword>
  <keyword>Web-based interventions</keyword>
  <keyword>Computer-tailoring</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Binge Drinking</mesh_term>
    <mesh_term>Alcohol Drinking</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ethanol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The IPD will be shared with other researchers through publications in scientific journals and congresses</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>From 2018</ipd_time_frame>
    <ipd_access_criteria>The Access Criteria will be the one exposed by the scientific journals where the results of the study will be published.</ipd_access_criteria>
  </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/NCT03288896
org study id: University of Seville. Spain
nct id: NCT03288896
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study consists in the the design, implementation, and evaluation of the first web-based
      computer tailored intervention program aimed at the prevention of binge drinking in Spanish
      adolescents (Alerta Alcohol). A Cluster Randomized Controlled Trial is conducted to test the
      effectiveness of Alerta Alcohol in students aged 16 to 18 years across 16 high schools from
      Andalusia (southern Spain), which are randomized either to the experimental or the control
      condition (EC and CC).
Binge-drinking in adolescents is a highly prevalent healthcare problem that associates
      physical and mental health complications and community implications.

      The "Alerta Alcohol" program is based on the I-Change Model. Focus and Delphi groups are used
      to obtain further information on items included in the program. A pilot study is conducted to
      identify strengths and weaknesses. A Cluster Randomized Controlled Trial is carried out. The
      schools from Andalusia are randomized either to the experimental or the control condition (EC
      and CC). The EC receives the Alerta Alcohol intervention, which consists of four sessions at
      school: baseline questionnaire and two sessions where adolescents are provided with answers
      related to their views to provide highly specific feedback regarding their knowledge, risk
      perception, self-esteem, attitude, social influence, and self-efficacy. In addition, two
      booster sessions are given at home to reinforce the contents. The CC just completes the
      baseline and the evaluation questionnaires and then they are allowed to receive the
      intervention as well (as a waiting list control condition). Evaluation takes place after four
      months. The primary endpoint is binge drinking within 30 days prior to evaluation and alcohol
      use in the previous week. It is expected that Alerta Alcohol reduces the prevalence of binge
      drinking by 10%. Follow up analyses are carried out to determine the differences in
      effectiveness according to the compliance of the program (quality of the implementation).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A Cluster Randomized Controlled Trial is conducted to test the effectiveness of Alerta Alcohol in students aged 16 to 18 years. The study is performed in 16 high schools from Andalusia (southern Spain), which are randomized either to the experimental or the control condition (EC and CC). The EC receives the Alerta Alcohol intervention, which consists of four sessions at school. The adolescents are provided highly specific feedback regarding their knowledge, risk perception, self-esteem, attitude, social influence, and self-efficacy. In addition, two booster sessions are given at home to reinforce the contents of the three scenarios. The CC just completes the baseline and the evaluation questionnaires and then they are allowed to receive the intervention as well (as a waiting list control condition).
primary purpose: Prevention
masking: None (Open Label)
measure: Reducing binge-drinking
time frame: 4 months after the baseline
description: Reducing binge-drinking (4/5 glasses or alcohol in one ocassion for a girl/boy) within 30 days prior to evaluation.
measure: Reducing weekly alcohol drinking
time frame: 4 months after the baseline
description: Reducing alcohol drinking within the 7 days prior to evaluation
arm group label: Alerta Alcohol
arm group type: Experimental
description: Intervention Group: The Experimental Group receives the Alerta Alcohol intervention, which consists of four sessions at school (baseline questionnaire, two sessions in three scenarios: at home, celebrations, and public places, and a final evaluation). The adolescents are provided with answers related to their views of each scenario; this information is used to provide highly specific feedback regarding their knowledge, risk perception, self-esteem, attitude, social influence (modelling, norms and social pressure), self-efficacy and action plans. In addition, two booster sessions are given at home to reinforce the contents of the three scenarios. Evaluation takes place after four months.
arm group label: Control Group
arm group type: No Intervention
description: Control Group: The Control Group just completes the baseline and the evaluation questionnaires and then they are allowed to receive the intervention as well (as a waiting list control condition). Evaluation takes place after four months from baseline
intervention type: Behavioral
intervention name: Alerta Alcohol
description: The intervention consists of preventive messages about the benefits of not consuming alcohol, reducing the positive attitudes and encouraging the negative attitudes towards alcohol drinking and binge drinking, as well as social influence and self-efficacy, by personalized feedback. Skills and action plans are encouraged to help the student to reject binge drinking. This information is presented through different tailored messages. Moreover, four avatars (two males and two females), which can be chosen as part of the story development. This story consists of a short story about the alcohol consumption by adolescents.The stories take place in three different scenarios (at home, at celebrations and in public places).
arm group label: Alerta Alcohol
other name: Alerta Alcohol, a web-based computer-tailored intervention
criteria: 
gender: All
minimum age: 16 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Marta Lima Serrano, PhD
role: Study Director
affiliation: University of Seville
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: University of Seville
investigator full name: Marta Lima Serrano
investigator title: PhD
mesh term: Binge Drinking
mesh term: Alcohol Drinking
mesh term: Ethanol
sharing ipd: Yes
ipd description: The IPD will be shared with other researchers through publications in scientific journals and congresses
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: From 2018
ipd access criteria: The Access Criteria will be the one exposed by the scientific journals where the results of the study will be published.