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/NCT06003439</url>
    </required_header>
    <id_info>
      <org_study_id>H-43102</org_study_id>
      <nct_id>NCT06003439</nct_id>
    </id_info>
    <brief_title>Vaping Cessation for Youth</brief_title>
    <acronym>Vapechat</acronym>
    <official_title>Virtual Reality Intervention to Promote Cessation of Nicotine Vaping in Youth</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Boston University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>American Heart Association</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Boston University</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>
        Many youth are addicted to nicotine due to increased nicotine vaping (e.g., e-cigarettes).&#xD;
        Unfortunately, there are no effective interventions to help teens quit vaping. In addition,&#xD;
        existing vaping prevention programs have limited effectiveness because they are out of touch&#xD;
        with teen's culture and are not appealing to the intended audience. Therefore, to be&#xD;
        effective, a vaping intervention must be acceptable, appealing, and engaging to teens, and&#xD;
        most importantly, it should be designed to be channeled into an existing infrastructure such&#xD;
        as the school setting.&#xD;
  &#xD;
        The investigators' research group has designed a vaping prevention and cessation intervention&#xD;
        that is implemented as a VR game for high school teens. The overall objective of this&#xD;
        research is to assess the acceptability, feasibility, and preliminary efficacy of the VR&#xD;
        experience among high school students in high school in Boston.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The investigators will conduct a randomized trial (N=150) of high school students (freshman&#xD;
        to seniors) in the Boston area to determine feasibility, satisfaction, and preliminary&#xD;
        efficacy of the VR-based vaping cessation and prevention game. Students will be randomized by&#xD;
        class to either receive the VR program (experimental condition) or control condition&#xD;
        (questionnaire assessment only). There will be three VR sessions played at school during a&#xD;
        health class. Participants in the VR condition will also engage in a gamified home-based&#xD;
        component on their smartphone, in order to reinforce skills learned in the school-based VR&#xD;
        experience.&#xD;
  &#xD;
        For every 4 - 5 classes enrolled in the VR condition, two will be enrolled in the control&#xD;
        condition. Participants will be enrolled in the study for approximately 5 weeks. In the first&#xD;
        3 weeks, participants will engage in the VR game experience once per week during their&#xD;
        classes. In the fourth and fifth week, participants may make up any VR game session that they&#xD;
        missed because of absence (e.g., illness). At week 5, participants will complete the&#xD;
        follow-up questionnaire assessments.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">January 2024</completion_date>
    <primary_completion_date type="Anticipated">January 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>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Engagement with the VR program</measure>
      <time_frame>5 weeks</time_frame>
      <description>Experimental condition arm. Playing time in minutes objectively measured by the program software; higher values mean a better outcome</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Satisfaction with the VR game</measure>
      <time_frame>5 weeks</time_frame>
      <description>Experimental condition arm. Self-report star rating of the VR game (1 to 5 stars); higher values mean a better outcome</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Awareness of vaping</measure>
      <time_frame>5 weeks</time_frame>
      <description>Experimental condition arm. Self-report awareness adapted from the Mobile App Rating Scale (MARS). Score range 1 - 5; higher values mean a better outcome</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Knowledge of vaping</measure>
      <time_frame>5 weeks</time_frame>
      <description>Experimental condition arm Self-report knowledge adapted from the Mobile App Rating Scale (MARS). Score range 1 - 5; higher values mean a better outcome</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Attitudes towards vaping</measure>
      <time_frame>5 weeks</time_frame>
      <description>Experimental condition arm. Self-report attitudes towards vaping adapted from the Mobile App Rating Scale (MARS). Score range 1 - 5; higher values mean a better outcome</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Intention to change</measure>
      <time_frame>5 weeks</time_frame>
      <description>Experimental condition arm. Self-report intention to change vaping behaviors adapted from the Mobile App Rating Scale (MARS). Score range 1 - 5; higher values mean a better outcome</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Help seeking</measure>
      <time_frame>5 weeks</time_frame>
      <description>Experimental condition arm. Self-report help seeking for vaping behaviors adapted from the Mobile App Rating Scale (MARS). Score range 1 - 5; higher values mean a better outcome</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Gameplay experience and satisfaction</measure>
      <time_frame>5 weeks</time_frame>
      <description>Experimental condition arm. Scores on a scale assessing the gameplay experience. Score range 1 - 4; higher values mean a better outcome</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Quit vaping attempts</measure>
      <time_frame>5 weeks</time_frame>
      <description>Proportion of participants who have made one or more attempts to quit vaping for at least 24 hours</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Past 30-days vaping frequency</measure>
      <time_frame>5 weeks</time_frame>
      <description>Proportion of participants who have vaped '0', or '1-2', or '3-5', or '6-9', or '10-19', or '20-30' days in the past 30-days</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Past 7-days vaping frequency</measure>
      <time_frame>5 weeks</time_frame>
      <description>Proportion of participants who have vaped '0', or '1-2', or '3-4', or '5-6', or '7' days in the past 7-days</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Frequency of current vaping</measure>
      <time_frame>5 weeks</time_frame>
      <description>Proportion of participants who currently vape 'not at all', or 'some days', or 'most days', or 'every day'</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Motivation to quit (or avoid) vaping within the next 30-days</measure>
      <time_frame>5 weeks</time_frame>
      <description>Proportion of participants who are seriously thinking about quitting (or avoid) vaping within the next 30-days</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Motivation to quit (or avoid) vaping</measure>
      <time_frame>5 weeks</time_frame>
      <description>Scores on a scale assessing motivation to quit (or avoid) vaping. Score range 1 - 10; higher values mean a better outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Intention to try vaping (or quit vaping)</measure>
      <time_frame>5 weeks</time_frame>
      <description>Proportion of participants who are 'probably not' or 'definitely not' thinking of vaping in the next 30- days</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Confidence in avoiding vaping</measure>
      <time_frame>5 weeks</time_frame>
      <description>Scores on a single item assessing confidence in avoiding vaping within 30-days. Scores range 1-10, higher values mean a better outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self-efficacy to resist vaping</measure>
      <time_frame>5 weeks</time_frame>
      <description>Scores on the adapted self-efficacy scale for adolescents. Scores range 0-90, higher values mean a better outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self-efficacy to refuse e-cigarettes</measure>
      <time_frame>5 weeks</time_frame>
      <description>Scores on an adapted self-efficacy scale for youth. Scores range 1-5, higher values mean a better outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Resilience</measure>
      <time_frame>5 weeks</time_frame>
      <description>Scores on a brief resilience scale. Scores range 0-18, higher values mean a better outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Positive affect</measure>
      <time_frame>5 weeks</time_frame>
      <description>Scores on the 'positive affect subscale' of the Positive and Negative Affect Schedule (PANAS). Scores range 10-50, higher values mean a better outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Negative affect</measure>
      <time_frame>5 weeks</time_frame>
      <description>Scores on the 'negative affect subscale' of the Positive and Negative Affect Schedule (PANAS). Scores range 10-50, higher values mean a worse outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tolerability of the VR game</measure>
      <time_frame>5 weeks</time_frame>
      <description>Experimental condition arm Scores on the VR sickness questionnaire. Scores range 1-4, higher values mean a worse outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Intention to connect with vaping cessation resources</measure>
      <time_frame>5 weeks</time_frame>
      <description>Scores on a single item assessing intentions to connect with vaping cessation resources. Scores range 1-10, higher values mean a better outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Psychological stress experience</measure>
      <time_frame>5 weeks</time_frame>
      <description>Scores on a scale assessing stress experiences. Scores range 0-32, higher values mean a worse outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Connection with vaping cessation resources</measure>
      <time_frame>5 weeks</time_frame>
      <description>Proportion of participants who have made contact with any vaping cessation resources during the study</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Vaping</condition>
    <condition>Smoking Cessation</condition>
    <arm_group>
      <arm_group_label>Virtual Reality Program</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Students in classrooms randomized to this group will receive the Virtual Reality vaping cessation and prevention program.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Assessment Only</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Students in classrooms randomized to this group will not receive the VR intervention but will complete questionnaire assessment only.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Virtual Reality Program</intervention_name>
      <description>The VR Program will be pre-installed on Meta Quest 2 headsets, which will be donned by students as a class to experience the intervention for approximately the length of one school class period (approximately 45 minutes). Each participant will experience the program once a week for 3 weeks. Participants who missed a week will complete the program by the 4th or 5th week.</description>
      <arm_group_label>Virtual Reality Program</arm_group_label>
      <other_name>VR Program</other_name>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Augmented Reality Program</intervention_name>
      <description>VR program participants will be able to download an optional mobile app that complements and reinforces the school-based VR session.</description>
      <arm_group_label>Virtual Reality Program</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Students enrolled at Public High Schools (freshmen, sophomores, juniors, and seniors).&#xD;
  &#xD;
            -  Must be able to speak and understand English.&#xD;
  &#xD;
            -  Child assents&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Teacher indicates that participation is not appropriate for the student (e.g., severe&#xD;
               mental illness; visual or auditory disability)&#xD;
  &#xD;
            -  Parent(s)/guardian(s) opt student out of the study.&#xD;
  &#xD;
            -  Prone to motion sickness or seizures.&#xD;
  &#xD;
            -  Blind or otherwise unable to use VR device.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>13 Years</minimum_age>
      <maximum_age>19 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Belinda Borrelli, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Boston University, Goldman School of Dental Medicine, Center for Behavioral Science Research</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Belinda Borrelli, PhD</last_name>
      <phone>(617) 358-3358</phone>
      <email>belindab@bu.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Daniel Weinstein, MSc</last_name>
      <phone>(617) 358-3358</phone>
      <email>dweinst1@bu.edu</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Virtual reality (VR)</keyword>
    <keyword>Augmented reality (AR)</keyword>
    <keyword>High School Students</keyword>
    <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/NCT06003439
  org study id: H-43102
  nct id: NCT06003439
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Many youth are addicted to nicotine due to increased nicotine vaping (e.g., e-cigarettes).
        Unfortunately, there are no effective interventions to help teens quit vaping. In addition,
        existing vaping prevention programs have limited effectiveness because they are out of touch
        with teen's culture and are not appealing to the intended audience. Therefore, to be
        effective, a vaping intervention must be acceptable, appealing, and engaging to teens, and
        most importantly, it should be designed to be channeled into an existing infrastructure such
        as the school setting.
  
        The investigators' research group has designed a vaping prevention and cessation intervention
        that is implemented as a VR game for high school teens. The overall objective of this
        research is to assess the acceptability, feasibility, and preliminary efficacy of the VR
        experience among high school students in high school in Boston.
  The investigators will conduct a randomized trial (N=150) of high school students (freshman
        to seniors) in the Boston area to determine feasibility, satisfaction, and preliminary
        efficacy of the VR-based vaping cessation and prevention game. Students will be randomized by
        class to either receive the VR program (experimental condition) or control condition
        (questionnaire assessment only). There will be three VR sessions played at school during a
        health class. Participants in the VR condition will also engage in a gamified home-based
        component on their smartphone, in order to reinforce skills learned in the school-based VR
        experience.
  
        For every 4 - 5 classes enrolled in the VR condition, two will be enrolled in the control
        condition. Participants will be enrolled in the study for approximately 5 weeks. In the first
        3 weeks, participants will engage in the VR game experience once per week during their
        classes. In the fourth and fifth week, participants may make up any VR game session that they
        missed because of absence (e.g., illness). At week 5, participants will complete the
        follow-up questionnaire assessments.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Engagement with the VR program
  time frame: 5 weeks
  description: Experimental condition arm. Playing time in minutes objectively measured by the program software; higher values mean a better outcome
  measure: Satisfaction with the VR game
  time frame: 5 weeks
  description: Experimental condition arm. Self-report star rating of the VR game (1 to 5 stars); higher values mean a better outcome
  measure: Awareness of vaping
  time frame: 5 weeks
  description: Experimental condition arm. Self-report awareness adapted from the Mobile App Rating Scale (MARS). Score range 1 - 5; higher values mean a better outcome
  measure: Knowledge of vaping
  time frame: 5 weeks
  description: Experimental condition arm Self-report knowledge adapted from the Mobile App Rating Scale (MARS). Score range 1 - 5; higher values mean a better outcome
  measure: Attitudes towards vaping
  time frame: 5 weeks
  description: Experimental condition arm. Self-report attitudes towards vaping adapted from the Mobile App Rating Scale (MARS). Score range 1 - 5; higher values mean a better outcome
  measure: Intention to change
  time frame: 5 weeks
  description: Experimental condition arm. Self-report intention to change vaping behaviors adapted from the Mobile App Rating Scale (MARS). Score range 1 - 5; higher values mean a better outcome
  measure: Help seeking
  time frame: 5 weeks
  description: Experimental condition arm. Self-report help seeking for vaping behaviors adapted from the Mobile App Rating Scale (MARS). Score range 1 - 5; higher values mean a better outcome
  measure: Gameplay experience and satisfaction
  time frame: 5 weeks
  description: Experimental condition arm. Scores on a scale assessing the gameplay experience. Score range 1 - 4; higher values mean a better outcome
  measure: Quit vaping attempts
  time frame: 5 weeks
  description: Proportion of participants who have made one or more attempts to quit vaping for at least 24 hours
  measure: Past 30-days vaping frequency
  time frame: 5 weeks
  description: Proportion of participants who have vaped '0', or '1-2', or '3-5', or '6-9', or '10-19', or '20-30' days in the past 30-days
  measure: Past 7-days vaping frequency
  time frame: 5 weeks
  description: Proportion of participants who have vaped '0', or '1-2', or '3-4', or '5-6', or '7' days in the past 7-days
  measure: Frequency of current vaping
  time frame: 5 weeks
  description: Proportion of participants who currently vape 'not at all', or 'some days', or 'most days', or 'every day'
  measure: Motivation to quit (or avoid) vaping within the next 30-days
  time frame: 5 weeks
  description: Proportion of participants who are seriously thinking about quitting (or avoid) vaping within the next 30-days
  measure: Motivation to quit (or avoid) vaping
  time frame: 5 weeks
  description: Scores on a scale assessing motivation to quit (or avoid) vaping. Score range 1 - 10; higher values mean a better outcome
  measure: Intention to try vaping (or quit vaping)
  time frame: 5 weeks
  description: Proportion of participants who are 'probably not' or 'definitely not' thinking of vaping in the next 30- days
  measure: Confidence in avoiding vaping
  time frame: 5 weeks
  description: Scores on a single item assessing confidence in avoiding vaping within 30-days. Scores range 1-10, higher values mean a better outcome
  measure: Self-efficacy to resist vaping
  time frame: 5 weeks
  description: Scores on the adapted self-efficacy scale for adolescents. Scores range 0-90, higher values mean a better outcome
  measure: Self-efficacy to refuse e-cigarettes
  time frame: 5 weeks
  description: Scores on an adapted self-efficacy scale for youth. Scores range 1-5, higher values mean a better outcome
  measure: Resilience
  time frame: 5 weeks
  description: Scores on a brief resilience scale. Scores range 0-18, higher values mean a better outcome
  measure: Positive affect
  time frame: 5 weeks
  description: Scores on the 'positive affect subscale' of the Positive and Negative Affect Schedule (PANAS). Scores range 10-50, higher values mean a better outcome
  measure: Negative affect
  time frame: 5 weeks
  description: Scores on the 'negative affect subscale' of the Positive and Negative Affect Schedule (PANAS). Scores range 10-50, higher values mean a worse outcome
  measure: Tolerability of the VR game
  time frame: 5 weeks
  description: Experimental condition arm Scores on the VR sickness questionnaire. Scores range 1-4, higher values mean a worse outcome
  measure: Intention to connect with vaping cessation resources
  time frame: 5 weeks
  description: Scores on a single item assessing intentions to connect with vaping cessation resources. Scores range 1-10, higher values mean a better outcome
  measure: Psychological stress experience
  time frame: 5 weeks
  description: Scores on a scale assessing stress experiences. Scores range 0-32, higher values mean a worse outcome
  measure: Connection with vaping cessation resources
  time frame: 5 weeks
  description: Proportion of participants who have made contact with any vaping cessation resources during the study
  arm group label: Virtual Reality Program
  arm group type: Experimental
  description: Students in classrooms randomized to this group will receive the Virtual Reality vaping cessation and prevention program.
  arm group label: Assessment Only
  arm group type: No Intervention
  description: Students in classrooms randomized to this group will not receive the VR intervention but will complete questionnaire assessment only.
  intervention type: Behavioral
  intervention name: Virtual Reality Program
  description: The VR Program will be pre-installed on Meta Quest 2 headsets, which will be donned by students as a class to experience the intervention for approximately the length of one school class period (approximately 45 minutes). Each participant will experience the program once a week for 3 weeks. Participants who missed a week will complete the program by the 4th or 5th week.
  arm group label: Virtual Reality Program
  other name: VR Program
  intervention type: Behavioral
  intervention name: Augmented Reality Program
  description: VR program participants will be able to download an optional mobile app that complements and reinforces the school-based VR session.
  arm group label: Virtual Reality Program
  criteria: 
  gender: All
  minimum age: 13 Years
  maximum age: 19 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Belinda Borrelli, PhD
  role: Principal Investigator
  affiliation: Boston University, Goldman School of Dental Medicine, Center for Behavioral Science Research
  last name: Belinda Borrelli, PhD
  phone: (617) 358-3358
  email: belindab@bu.edu
  last name: Daniel Weinstein, MSc
  phone: (617) 358-3358
  email: dweinst1@bu.edu
  responsible party type: Sponsor
  sharing ipd: No