<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/NCT03815591</url>
  </required_header>
  <id_info>
    <org_study_id>2000023070</org_study_id>
    <nct_id>NCT03815591</nct_id>
  </id_info>
  <brief_title>Implementation and Dissemination of an Evidence-Based Tobacco Product Use Prevention Videogame Intervention With Adolescents</brief_title>
  <official_title>Implementation and Dissemination of an Evidence-Based Tobacco Product Use Prevention Videogame Intervention With Adolescents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yale University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To examine the effects on participants who play the smokeSCREEN game in that the game will&#xD;
      have positive changes in their attitudes, beliefs, knowledge, intentions, behaviors and other&#xD;
      outcomes related to smoking and tobacco products.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      For this project, the CVS Pharmacy Health Foundation has identified after-school, school, and&#xD;
      youth programs nationwide with whom to partner. For this project, the play2PREVENT Lab will&#xD;
      provide these programs access to the tobacco use reduction/prevention game that the lab has&#xD;
      created (smokeSCREEN). Program and school staff will enroll participants between the ages of&#xD;
      10-16 to play smokeSCREEN during their after school, school, and youth program. Before and&#xD;
      after gameplay, participants will answer assessment questions related to their attitudes,&#xD;
      beliefs, knowledge, intentions, and behaviors around smoking and tobacco product use. The&#xD;
      data will be transmitted electronically via the LimeSurvey data collection platform to the&#xD;
      Lab, for further analysis. None of the Lab staff will have contact with participants or&#xD;
      after-school/school/youth program coordinators or staff.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">December 31, 2021</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in beliefs</measure>
    <time_frame>baseline</time_frame>
    <description>Participants completed a pre-survey through a secured, data collection website (LimeSurvey Data Collection Software), after they have played the videogame intervention. Fourteen questions were designed from the National Youth Tobacco Survey (2014)13 that focused on beliefs about cigarettes, e-cigarettes, and flavored tobacco were used for the survey. For beliefs, questions had 4-5 choices ranging from strongly disagree to strongly agree or definitely yes to definitely not, or 5 responses ranging from unlikely to very likely.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in beliefs</measure>
    <time_frame>immediately after game play is completed</time_frame>
    <description>Participants completed a post-survey through a secured, data collection website (LimeSurvey Data Collection Software), after they have played the videogame intervention. Fourteen questions were designed from the National Youth Tobacco Survey (2014)13 that focused on beliefs about cigarettes, e-cigarettes, and flavored tobacco were used for the survey. For beliefs, questions had 4-5 choices ranging from strongly disagree to strongly agree or definitely yes to definitely not, or 5 responses ranging from unlikely to very likely.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in knowledge</measure>
    <time_frame>Baseline</time_frame>
    <description>Participants completed a pre-survey through a secured, data collection website (LimeSurvey Data Collection Software), played the videogame intervention. Fourteen questions were designed from the National Youth Tobacco Survey (2014)13 that focused on knowledge about cigarettes, e-cigarettes, and flavored tobacco were used for the surveys. For knowledge, questions had 3 response choices (yes, not, and not sure).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in knowledge</measure>
    <time_frame>immediately after game play is completed</time_frame>
    <description>Participants completed a post-survey through a secured, data collection website (LimeSurvey Data Collection Software), played the videogame intervention. Fourteen questions were designed from the National Youth Tobacco Survey (2014)13 that focused on knowledge about cigarettes, e-cigarettes, and flavored tobacco were used for the surveys. For knowledge, questions had 3 response choices (yes, not, and not sure).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in intentions</measure>
    <time_frame>Baseline</time_frame>
    <description>Participants will complete a pre-survey through a secured, data collection website (LimeSurvey Data Collection Software), immediately before playing the videogame intervention. Survey questions, adapted from the National Youth and Tobacco Use Survey (FDA, 2018), will assess participants' intention of using cigarettes, e-cigarettes, and flavored tobacco. For questions assessing participants' intention of using tobacco products, response options range from definitely not to definitely yes (4 choices).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in behaviors</measure>
    <time_frame>Immediately after gameplay is completed</time_frame>
    <description>Participants will complete a pre-survey through a secured, data collection website (LimeSurvey Data Collection Software), immediately before playing the videogame intervention. Survey questions, adapted from the National Youth and Tobacco Use Survey (FDA, 2018), will assess participants' intention of using cigarettes, e-cigarettes, and flavored tobacco. For questions assessing participants' intention of using tobacco products, response options range from definitely not to definitely yes (4 choices).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in social norms</measure>
    <time_frame>Baseline</time_frame>
    <description>Participants will complete a pre-survey through a secured, data collection website (LimeSurvey Data Collection Software), immediately before playing the videogame intervention. Survey questions, adapted from the National Youth and Tobacco Use Survey (FDA, 2018), will assess participants' social norms surrounding the use of cigarettes, ecigarettes, and flavored tobacco. Questions assessing the number of friends/peers who use tobacco products will range from 0 to 4 (including an &quot;I don't know&quot; option). Questions, such as &quot;How would your best friends act toward you if you smoked cigarettes,&quot; have response options ranging from very unfriendly to very friendly (4 choices).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in social norms</measure>
    <time_frame>Immediately after gameplay is completed</time_frame>
    <description>Participants will complete a pre-survey through a secured, data collection website (LimeSurvey Data Collection Software), immediately before playing the videogame intervention. Survey questions, adapted from the National Youth and Tobacco Use Survey (FDA, 2018), will assess participants' social norms surrounding the use of cigarettes, ecigarettes, and flavored tobacco. Questions assessing the number of friends/peers who use tobacco products will range from 0 to 4 (including an &quot;I don't know&quot; option). Questions, such as &quot;How would your best friends act toward you if you smoked cigarettes,&quot; have response options ranging from very unfriendly to very friendly (4 choices).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gameplay satisfaction: post-test survey</measure>
    <time_frame>immediately after game play is completed</time_frame>
    <description>The post-test survey, administered through a secured, data collection website (LimeSurvey Data Collection Software), will include an additional 10 items on the game intervention experience and satisfaction from items designed for a previous videogame study on sexual risk reduction in young adolescents; 4 response choices ranging from strongly disagree to strongly agree.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">560</enrollment>
  <condition>Smoking Cessation</condition>
  <condition>Smoking</condition>
  <arm_group>
    <arm_group_label>adolescents between ages of 10-16</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adolescents given a pre-post survey to measure the effect of the game and building that into the smokeSCREEN video game to anonymously collect information on players' perspectives, beliefs, attitudes, intentions, social norms, and behaviors around tobacco use, and collaborating with youth programs to pilot test how the game can be implemented in real world settings.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>smokeSCREEN web-based game</intervention_name>
    <description>smokeSCREEN tobacco use reduction/prevention web-based game. The game has 1.5-2 hours of unique game play and focuses on combustible cigarettes, e-cigarettes, and flavored tobacco products. Guided by the social cognitive theory and the theory of planned behavior, smokeSCREEN addresses a range of challenges that teens often face involving peer pressure and the use of tobacco products. Participants are provided access to the smokeSCREEN game through a private, password-protected website link and instructed to complete the game.</description>
    <arm_group_label>adolescents between ages of 10-16</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Anyone with a userID and password.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Does not fit the inclusion criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lynn Fiellin, MD</last_name>
    <role>Study Director</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>play2PREVENT Lab at the Yale Center for Health &amp; Learning Games</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06519</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>April 21, 2022</last_update_submitted>
  <last_update_submitted_qc>April 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>smoking</keyword>
  <keyword>tobacco</keyword>
  <keyword>e-cigarettes</keyword>
  <keyword>flavored tobacco</keyword>
  <!-- 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/NCT03815591
org study id: 2000023070
nct id: NCT03815591
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To examine the effects on participants who play the smokeSCREEN game in that the game will
      have positive changes in their attitudes, beliefs, knowledge, intentions, behaviors and other
      outcomes related to smoking and tobacco products.
For this project, the CVS Pharmacy Health Foundation has identified after-school, school, and
      youth programs nationwide with whom to partner. For this project, the play2PREVENT Lab will
      provide these programs access to the tobacco use reduction/prevention game that the lab has
      created (smokeSCREEN). Program and school staff will enroll participants between the ages of
      10-16 to play smokeSCREEN during their after school, school, and youth program. Before and
      after gameplay, participants will answer assessment questions related to their attitudes,
      beliefs, knowledge, intentions, and behaviors around smoking and tobacco product use. The
      data will be transmitted electronically via the LimeSurvey data collection platform to the
      Lab, for further analysis. None of the Lab staff will have contact with participants or
      after-school/school/youth program coordinators or staff.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Changes in beliefs
time frame: baseline
description: Participants completed a pre-survey through a secured, data collection website (LimeSurvey Data Collection Software), after they have played the videogame intervention. Fourteen questions were designed from the National Youth Tobacco Survey (2014)13 that focused on beliefs about cigarettes, e-cigarettes, and flavored tobacco were used for the survey. For beliefs, questions had 4-5 choices ranging from strongly disagree to strongly agree or definitely yes to definitely not, or 5 responses ranging from unlikely to very likely.
measure: Changes in beliefs
time frame: immediately after game play is completed
description: Participants completed a post-survey through a secured, data collection website (LimeSurvey Data Collection Software), after they have played the videogame intervention. Fourteen questions were designed from the National Youth Tobacco Survey (2014)13 that focused on beliefs about cigarettes, e-cigarettes, and flavored tobacco were used for the survey. For beliefs, questions had 4-5 choices ranging from strongly disagree to strongly agree or definitely yes to definitely not, or 5 responses ranging from unlikely to very likely.
measure: Change in knowledge
time frame: Baseline
description: Participants completed a pre-survey through a secured, data collection website (LimeSurvey Data Collection Software), played the videogame intervention. Fourteen questions were designed from the National Youth Tobacco Survey (2014)13 that focused on knowledge about cigarettes, e-cigarettes, and flavored tobacco were used for the surveys. For knowledge, questions had 3 response choices (yes, not, and not sure).
measure: Change in knowledge
time frame: immediately after game play is completed
description: Participants completed a post-survey through a secured, data collection website (LimeSurvey Data Collection Software), played the videogame intervention. Fourteen questions were designed from the National Youth Tobacco Survey (2014)13 that focused on knowledge about cigarettes, e-cigarettes, and flavored tobacco were used for the surveys. For knowledge, questions had 3 response choices (yes, not, and not sure).
measure: Change in intentions
time frame: Baseline
description: Participants will complete a pre-survey through a secured, data collection website (LimeSurvey Data Collection Software), immediately before playing the videogame intervention. Survey questions, adapted from the National Youth and Tobacco Use Survey (FDA, 2018), will assess participants' intention of using cigarettes, e-cigarettes, and flavored tobacco. For questions assessing participants' intention of using tobacco products, response options range from definitely not to definitely yes (4 choices).
measure: Change in behaviors
time frame: Immediately after gameplay is completed
description: Participants will complete a pre-survey through a secured, data collection website (LimeSurvey Data Collection Software), immediately before playing the videogame intervention. Survey questions, adapted from the National Youth and Tobacco Use Survey (FDA, 2018), will assess participants' intention of using cigarettes, e-cigarettes, and flavored tobacco. For questions assessing participants' intention of using tobacco products, response options range from definitely not to definitely yes (4 choices).
measure: Changes in social norms
time frame: Baseline
description: Participants will complete a pre-survey through a secured, data collection website (LimeSurvey Data Collection Software), immediately before playing the videogame intervention. Survey questions, adapted from the National Youth and Tobacco Use Survey (FDA, 2018), will assess participants' social norms surrounding the use of cigarettes, ecigarettes, and flavored tobacco. Questions assessing the number of friends/peers who use tobacco products will range from 0 to 4 (including an "I don't know" option). Questions, such as "How would your best friends act toward you if you smoked cigarettes," have response options ranging from very unfriendly to very friendly (4 choices).
measure: Changes in social norms
time frame: Immediately after gameplay is completed
description: Participants will complete a pre-survey through a secured, data collection website (LimeSurvey Data Collection Software), immediately before playing the videogame intervention. Survey questions, adapted from the National Youth and Tobacco Use Survey (FDA, 2018), will assess participants' social norms surrounding the use of cigarettes, ecigarettes, and flavored tobacco. Questions assessing the number of friends/peers who use tobacco products will range from 0 to 4 (including an "I don't know" option). Questions, such as "How would your best friends act toward you if you smoked cigarettes," have response options ranging from very unfriendly to very friendly (4 choices).
measure: Gameplay satisfaction: post-test survey
time frame: immediately after game play is completed
description: The post-test survey, administered through a secured, data collection website (LimeSurvey Data Collection Software), will include an additional 10 items on the game intervention experience and satisfaction from items designed for a previous videogame study on sexual risk reduction in young adolescents; 4 response choices ranging from strongly disagree to strongly agree.
arm group label: adolescents between ages of 10-16
arm group type: Experimental
description: Adolescents given a pre-post survey to measure the effect of the game and building that into the smokeSCREEN video game to anonymously collect information on players' perspectives, beliefs, attitudes, intentions, social norms, and behaviors around tobacco use, and collaborating with youth programs to pilot test how the game can be implemented in real world settings.
intervention type: Device
intervention name: smokeSCREEN web-based game
description: smokeSCREEN tobacco use reduction/prevention web-based game. The game has 1.5-2 hours of unique game play and focuses on combustible cigarettes, e-cigarettes, and flavored tobacco products. Guided by the social cognitive theory and the theory of planned behavior, smokeSCREEN addresses a range of challenges that teens often face involving peer pressure and the use of tobacco products. Participants are provided access to the smokeSCREEN game through a private, password-protected website link and instructed to complete the game.
arm group label: adolescents between ages of 10-16
criteria: 
gender: All
minimum age: 10 Years
maximum age: 16 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Lynn Fiellin, MD
role: Study Director
affiliation: Yale University
facility: 
country: United States
responsible party type: Sponsor