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A Virtual Reality Videogame for E-cigarette Prevention in Teens

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04054765
Recruitment Status : Not yet recruiting
First Posted : August 13, 2019
Last Update Posted : August 29, 2019
Sponsor:
Information provided by (Responsible Party):
Yale University

Brief Summary:
The use of the smokeSCREEN VR (Invite Only VR), with the aim to prevent the initiation of e-cigarette use in teens by increasing their knowledge, decreasing their intentions to use e-cigarettes, influencing their harm perceptions and attitudes associated with e-cigarettes, and increasing self-efficacy associated with refusing peers involving e-cigarettes.

Condition or disease Intervention/treatment Phase
E-Cig Use Vaping Device: videogame Device: VR videogame Not Applicable

Detailed Description:

Specific Aim #1: DEVELOPMENT: The researcher will update our current smokeSCREEN VR prototype into a polished videogame intervention using input from 4 focus groups of 5 adolescents each (n = 20), aged 12-17 and the extant literature. These focus groups will inform the development of the VR videogame intervention, smokeSCREEN VR, for e-cigarette prevention among teens.

Specific Aim #2: EVALUATION: Conduct a pilot randomized controlled trial with 230 teens ages 12-15 comparing the smokeSCREEN VR intervention vs. an attention/control non-health-related VR videogame, collecting assessment data at baseline, post-gameplay, three months and six months to determine:

  1. the preliminary impact of the intervention on knowledge, intentions, perceptions, attitudes, social norms, self-efficacy and behaviors related to: i) initiation of e-cigarette use, ii) e-cigarette use cessation.
  2. the intervention's acceptability and feasibility by collecting quantitative and qualitative data on teens' satisfaction and gameplay experience of the intervention.
  3. preliminary evidence of the impact of smokeSCREEN VR on players' perception and experience of social pressure and social norm development

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized controlled trial with 230 teens ages 12-15 comparing the smokeSCREEN VR intervention vs. an attention/control non-health-related VR videogame
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: A Virtual Reality Videogame for E-cigarette Prevention in Teens
Estimated Study Start Date : September 15, 2019
Estimated Primary Completion Date : June 15, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: E-Cigarettes

Arm Intervention/treatment
Experimental: Teens in the smokeSCREEN VR videogame
115 adolescents playing the smokeSCREEN VR intervention
Device: videogame
smokeSCREEN VR videogame

Active Comparator: Teens in an Attention/Control non-health-related VR videogame
115 adolescents playing an attention/control non-health-related VR videogame
Device: VR videogame
attention/control non-health-related VR videogame




Primary Outcome Measures :
  1. A change in initiation of e-cigarettes [ Time Frame: 6 months ]
    The researcher will measure the percent of individuals who, after playing smokeSCREEN VR, report the initiation of e-cigarette use in comparison to the control condition.

  2. A change in cessation of e-cigarettes [ Time Frame: 6 months ]
    The researcher will measure the percent of individuals who, after playing smokeSCREEN VR, reduce e-cigarette use in comparison to the control condition.

  3. Determine the impact of a VR videogame on behaviors [ Time Frame: 6 months ]
    To determine the impact of a VR videogame on participants' behaviors associated with the percent uptake of e-cigarettes.


Secondary Outcome Measures :
  1. Attitudes towards e-cigarettes pre-test [ Time Frame: baseline ]
    To determine the impact of a VR prevention videogame intervention prototype, Invite Only VR, on participants' attitudes involving e-cigarette use - pretest survey. Participants will complete a pre-survey through a secured, data collection website (Qualtrics Data Collection Software) and then play the videogame intervention. The survey includes questions adapted from the National Youth Tobacco Survey (2014) focus on attitudes about e-cigarettes. Questions have 4-5 choices ranging from strongly disagree to strongly agree or definitely yes to definitely not, or 5 response choices ranging from very unlikely to very likely.

  2. Attitudes towards e-cigarettes post-test [ Time Frame: immediately after gameplay is completed ]
    To determine the impact of a VR prevention videogame intervention prototype, Invite Only VR, on participants' attitudes involving e-cigarette use - post-test survey. Participants will complete a pre-survey through a secured, data collection website (Qualtrics Data Collection Software) and then play the videogame intervention. The survey includes questions adapted from the National Youth Tobacco Survey (2014) focus on attitudes about e-cigarettes. Questions have 4-5 choices ranging from strongly disagree to strongly agree or definitely yes to definitely not, or 5 response choices ranging from very unlikely to very likely.

  3. Attitudes towards e-cigarettes post-test [ Time Frame: 3 months after gameplay is completed ]
    To determine the impact of a VR prevention videogame intervention prototype, Invite Only VR, on participants' attitudes involving e-cigarette use - post-test survey. Participants will complete a pre-survey through a secured, data collection website (Qualtrics Data Collection Software) and then play the videogame intervention. The survey includes questions adapted from the National Youth Tobacco Survey (2014) focus on attitudes about e-cigarettes. Questions have 4-5 choices ranging from strongly disagree to strongly agree or definitely yes to definitely not, or 5 response choices ranging from very unlikely to very likely.

  4. Attitudes towards e-cigarettes post-test [ Time Frame: 6 months after gameplay is completed ]
    To determine the impact of a VR prevention videogame intervention prototype, Invite Only VR, on participants' attitudes involving e-cigarette use - post-test survey. Participants will complete a pre-survey through a secured, data collection website (Qualtrics Data Collection Software) and then play the videogame intervention. The survey includes questions adapted from the National Youth Tobacco Survey (2014) focus on attitudes about e-cigarettes. Questions have 4-5 choices ranging from strongly disagree to strongly agree or definitely yes to definitely not, or 5 response choices ranging from very unlikely to very likely.

  5. Knowledge of e-cigarettes pre-test [ Time Frame: baseline ]
    To determine the impact of a VR prevention videogame intervention prototype, Invite Only VR, on participants' knowledge about e-cigarettes - post-test survey. Participants will complete a pre-survey through a secured, data collection website (Qualtrics Data Collection Software), before playing the videogame intervention. The survey includes questions adapted from the National Youth Tobacco Survey (2014) focus on knowledge about e-cigarettes. For knowledge, questions have 3 response choices (yes, no, and not sure).

  6. Knowledge of e-cigarettes post-test [ Time Frame: immediately after gameplay ]
    To determine the impact of a VR prevention videogame intervention prototype, Invite Only VR, on participants' knowledge about e-cigarettes- post-test survey. Participants will complete a post-survey through a secured, data collection website (Qualtrics Data Collection Software), before playing the videogame intervention. The survey includes questions adapted from the National Youth Tobacco Survey (2014) focus on knowledge about e-cigarettes. For knowledge, questions have 3 response choices (yes, no, and not sure).

  7. Knowledge of e-cigarettes post-test [ Time Frame: 3 months after gameplay ]
    To determine the impact of a VR prevention videogame intervention prototype, Invite Only VR, on participants' knowledge about e-cigarettes- post-test survey. Participants will complete a post-survey through a secured, data collection website (Qualtrics Data Collection Software), before playing the videogame intervention. The survey includes questions adapted from the National Youth Tobacco Survey (2014) focus on knowledge about e-cigarettes. For knowledge, questions have 3 response choices (yes, no, and not sure).

  8. Knowledge of e-cigarettes post-test [ Time Frame: 6 months after gameplay ]
    To determine the impact of a VR prevention videogame intervention prototype, Invite Only VR, on participants' knowledge about e-cigarettes- post-test survey. Participants will complete a post-survey through a secured, data collection website (Qualtrics Data Collection Software), before playing the videogame intervention. The survey includes questions adapted from the National Youth Tobacco Survey (2014) focus on knowledge about e-cigarettes. For knowledge, questions have 3 response choices (yes, no, and not sure).

  9. Intentions of e-cigarettes pre-test [ Time Frame: baseline ]
    To determine the impact of a VR prevention videogame intervention prototype, Invite Only VR, on participants' intentions involving e-cigarette use - pretest survey. Participants will complete a pre-survey through a secured, data collection website (Qualtrics Data Collection Software) and then play the videogame intervention. The survey includes questions adapted from the National Youth Tobacco Survey (2014) focus on intentions to use about e-cigarettes. Questions have 4-5 choices ranging from strongly disagree to strongly agree or definitely yes to definitely not, or 5 response choices ranging from very unlikely to very likely.

  10. Intentions of e-cigarettes post-test [ Time Frame: immediately after gameplay ]
    To determine the impact of a VR prevention videogame intervention prototype, Invite Only VR, on participants' intentions involving e-cigarette use - post test survey. Participants will complete a post-survey through a secured, data collection website (Qualtrics Data Collection Software) and then play the videogame intervention. The survey includes questions adapted from the National Youth Tobacco Survey (2014) focus on intentions to use e-cigarettes. Questions have 4-5 choices ranging from strongly disagree to strongly agree or definitely yes to definitely not, or 5 response choices ranging from very unlikely to very likely.

  11. Intentions of e-cigarettes post-test [ Time Frame: 3 months after gameplay ]
    To determine the impact of a VR prevention videogame intervention prototype, Invite Only VR, on participants' intentions involving e-cigarette use - post test survey. Participants will complete a post-survey through a secured, data collection website (Qualtrics Data Collection Software) and then play the videogame intervention. The survey includes questions adapted from the National Youth Tobacco Survey (2014) focus on intentions to use e-cigarettes. Questions have 4-5 choices ranging from strongly disagree to strongly agree or definitely yes to definitely not, or 5 response choices ranging from very unlikely to very likely.

  12. Intentions of e-cigarettes post-test [ Time Frame: 6 months after gameplay ]
    To determine the impact of a VR prevention videogame intervention prototype, Invite Only VR, on participants' intentions involving e-cigarette use - post test survey. Participants will complete a post-survey through a secured, data collection website (Qualtrics Data Collection Software) and then play the videogame intervention. The survey includes questions adapted from the National Youth Tobacco Survey (2014) focus on intentions to use e-cigarettes. Questions have 4-5 choices ranging from strongly disagree to strongly agree or definitely yes to definitely not, or 5 response choices ranging from very unlikely to very likely.

  13. Perceptions involving e-cigarettes pretest [ Time Frame: baseline ]
    To determine the impact of a VR prevention videogame intervention prototype, Invite Only VR, on participants' harm perceptions involving e-cigarette use - pretest survey. Participants will complete a pre-survey through a secured, data collection website (Qualtrics Data Collection Software) and then play the videogame intervention. The survey includes questions adapted from the National Youth Tobacco Survey (2014) focus on harm perceptions about e-cigarettes. Questions have 4-5 choices ranging from strongly disagree to strongly agree or definitely yes to definitely not, or 5 response choices ranging from very unlikely to very likely.

  14. Perceptions involving e-cigarettes post-test [ Time Frame: immediately after gameplay is completed ]
    To determine the impact of a VR prevention videogame intervention prototype, Invite Only VR, on participants' harm perceptions involving e-cigarette use - post-test survey. Participants will complete a pre-survey through a secured, data collection website (Qualtrics Data Collection Software) and then play the videogame intervention. The survey includes questions adapted from the National Youth Tobacco Survey (2014) focus on harm perceptions about e-cigarettes. Questions have 4-5 choices ranging from strongly disagree to strongly agree or definitely yes to definitely not, or 5 response choices ranging from very unlikely to very likely.

  15. Perceptions involving e-cigarettes post-test [ Time Frame: 3 months after gameplay is completed ]
    To determine the impact of a VR prevention videogame intervention prototype, Invite Only VR, on participants' harm perceptions involving e-cigarette use - post-test survey. Participants will complete a pre-survey through a secured, data collection website (Qualtrics Data Collection Software) and then play the videogame intervention. The survey includes questions adapted from the National Youth Tobacco Survey (2014) focus on harm perceptions about e-cigarettes. Questions have 4-5 choices ranging from strongly disagree to strongly agree or definitely yes to definitely not, or 5 response choices ranging from very unlikely to very likely.

  16. Perceptions involving e-cigarettes post-test [ Time Frame: 6 months after gameplay is completed ]
    To determine the impact of a VR prevention videogame intervention prototype, Invite Only VR, on participants' harm perceptions involving e-cigarette use - post-test survey. Participants will complete a pre-survey through a secured, data collection website (Qualtrics Data Collection Software) and then play the videogame intervention. The survey includes questions adapted from the National Youth Tobacco Survey (2014) focus on harm perceptions about e-cigarettes. Questions have 4-5 choices ranging from strongly disagree to strongly agree or definitely yes to definitely not, or 5 response choices ranging from very unlikely to very likely.

  17. Refuse e-cigarettes pre-test [ Time Frame: baseline ]
    To determine the impact of a VR prevention videogame intervention prototype, Invite Only VR, on participants' self-efficacy to refuse e-cigarettes - pretest survey. Participants will complete a pre-survey through a secured, data collection website (Qualtrics Data Collection Software) and then play the videogame intervention. The survey includes questions adapted from the National Youth Tobacco Survey (2014) focus on self-efficacy to refuse e-cigarettes.. Questions have 4-5 choices ranging from strongly disagree to strongly agree or definitely yes to definitely not, or 5 response choices ranging from very unlikely to very likely.

  18. Refuse e-cigarettes post-test [ Time Frame: immediately after gameplay ]
    To determine the impact of a VR prevention videogame intervention prototype, Invite Only VR, on participants' self-efficacy to refuse e-cigarettes - post-test survey. Participants will complete a pre-survey through a secured, data collection website (Qualtrics Data Collection Software) and then play the videogame intervention. The survey includes questions adapted from the National Youth Tobacco Survey (2014) focus on self-efficacy to refuse e-cigarettes.. Questions have 4-5 choices ranging from strongly disagree to strongly agree or definitely yes to definitely not, or 5 response choices ranging from very unlikely to very likely.

  19. Refuse e-cigarettes post-test [ Time Frame: 3 months after gameplay ]
    To determine the impact of a VR prevention videogame intervention prototype, Invite Only VR, on participants' self-efficacy to refuse e-cigarettes - post-test survey. Participants will complete a pre-survey through a secured, data collection website (Qualtrics Data Collection Software) and then play the videogame intervention. The survey includes questions adapted from the National Youth Tobacco Survey (2014) focus on self-efficacy to refuse e-cigarettes.. Questions have 4-5 choices ranging from strongly disagree to strongly agree or definitely yes to definitely not, or 5 response choices ranging from very unlikely to very likely.

  20. Refuse e-cigarettes post-test [ Time Frame: 6 months after gameplay ]
    To determine the impact of a VR prevention videogame intervention prototype, Invite Only VR, on participants' self-efficacy to refuse e-cigarettes - post-test survey. Participants will complete a pre-survey through a secured, data collection website (Qualtrics Data Collection Software) and then play the videogame intervention. The survey includes questions adapted from the National Youth Tobacco Survey (2014) focus on self-efficacy to refuse e-cigarettes.. Questions have 4-5 choices ranging from strongly disagree to strongly agree or definitely yes to definitely not, or 5 response choices ranging from very unlikely to very likely.


Other Outcome Measures:
  1. Satisfaction with gameplay experience - experimental only [ Time Frame: immediately after gameplay ]
    To determine participants' satisfaction and gameplay experience - posttest survey (experimental only) Participants will complete a post-survey through a secured, data collection website (Qualtrics Data Collection Software). The survey includes questions adapted from a survey developed at the play2PREVENT Lab about gameplay satisfaction and experience. Questions have 4-5 choices ranging from strongly disagree to strongly agree or definitely yes to definitely not, or 5 response choices ranging from very unlikely to very likely.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Willing to wear a VR headset and play a video game for 45-60 minutes and answer questions before and after playing the videogame.
  • Be enrolled in Milford Middle School District

Exclusion Criteria:

  • If subject does not fit the criteria above

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04054765


Contacts
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Contact: Kimberly Hieftje, PhD 203-737-5595 kimberly.hieftje@yale.edu

Locations
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United States, Connecticut
Milford School District Not yet recruiting
Milford, Connecticut, United States, 06460
Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Lynn Fiellin, PhD Yale University

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT04054765     History of Changes
Other Study ID Numbers: 2000025177
First Posted: August 13, 2019    Key Record Dates
Last Update Posted: August 29, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yale University:
prevention
intervention