Milford School District
Milford, Connecticut, 06460, United States
NCT Number: NCT04054765
The use of the 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.
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Notify MeSpecific Aim #1: DEVELOPMENT: The researcher will update our current 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, Invite Only VR, for e-cigarette prevention among teens.
Specific Aim #2: EVALUATION: Conduct a pilot non-randomized cluster trial with 295 teens ages 11-14 comparing the Invite Only 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:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Invite Only VR videogame
treatment as usual
Time frame: 6 months
The researcher will measure the percent of individuals who, after playing Invite Only VR, report the initiation of e-cigarette use in comparison to the control condition.
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 4 questions adapted from the National Youth Tobacco Survey (2014) focus on attitudes about e-cigarettes. Questions have 4 response choices ranging from 1 (strongly disagree) to 4 (strongly agree) or 1 (definitely yes) to 4 (definitely not), or 1 (very unlikely) to 4 (very likely). Some items were reverse coded so that scores of 1 always represented less healthy attitudes and scores of 4 corresponded to more healthy attitudes. Items were averaged into a composite scale that ranged from 1 to 4, with higher scores indicating healthier attitudes.
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 post-survey through a secured, data collection website (Qualtrics Data Collection Software) after playing the videogame intervention. The survey includes 4 questions adapted from the National Youth Tobacco Survey (2014) focus on attitudes about e-cigarettes. Questions have 4 response choices ranging from 1 (strongly disagree) to 4 (strongly agree) or 1 (definitely yes) to 4 (definitely not), or 1 (very unlikely) to 4 (very likely). Questions are reverse coded such that higher scores represent healthier attitudes towards e-cigarettes.
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 - 3 months post-test survey. The survey includes 4 questions adapted from the National Youth Tobacco Survey (2014) focus on attitudes about e-cigarettes. Questions have 4 response choices ranging from 1 (strongly disagree) to 4 (strongly agree) or 1 (definitely yes) to 4 (definitely not), or 1 (very unlikely) to 4 (very likely). Some items were reverse coded so that scores of 1 always represented less healthy attitudes and scores of 4 corresponded to more healthy attitudes. Items were averaged into a composite scale that ranged from 1 to 4, with higher scores indicating healthier attitudes.
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 - 6 months post-test survey. Participants will complete a survey through a secured, data collection website (Qualtrics Data Collection Software). The survey includes 4 questions adapted from the National Youth Tobacco Survey (2014) focus on attitudes about e-cigarettes. Questions have 4 response choices ranging from 1 (strongly disagree) to 4 (strongly agree) or 1 (definitely yes) to 4 (definitely not), or 1 (very unlikely) to 4 (very likely). Some items were reverse coded so that scores of 1 always represented less healthy attitudes and scores of 4 corresponded to more healthy attitudes. Items were averaged into a composite scale that ranged from 1 to 4, with higher scores indicating healthier attitudes.
Time frame: baseline
To determine the impact of a VR prevention videogame intervention prototype, Invite Only VR, on participants' knowledge about e-cigarettes - pre-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 15 questions adapted from the National Youth Tobacco Survey (2014) focus on knowledge about e-cigarettes. For knowledge, questions have 3 response choices (True, False, and not sure). Correct answers are scored as 1, incorrect are scored as 0, and not sure responses are also scored as 0. Total scores range from 0 to 15, with higher scores indicating better performance.
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), after playing the videogame intervention. The survey includes 15 questions adapted from the National Youth Tobacco Survey (2014) focus on knowledge about e-cigarettes. For knowledge, questions have 3 response choices (True, False, and not sure). Correct answers are scored as 1, incorrect are scored as 0, and not sure responses are also scored as 0. Total scores range from 0 to 15, with higher scores indicating better performance.
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- 3 months post-test survey. Participants will complete a post-survey through a secured, data collection website (Qualtrics Data Collection Software). The survey includes 15 questions adapted from the National Youth Tobacco Survey (2014) focus on knowledge about e-cigarettes. For knowledge, questions have 3 response choices (True, False, and not sure). Correct answers are scored as 1, incorrect are scored as 0, and not sure responses are also scored as 0. Total scores range from 0 to 15, with higher scores indicating better performance.
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- 6 months post-test survey. Participants will complete a post-survey through a secured, data collection website (Qualtrics Data Collection Software). The survey includes 15 questions adapted from the National Youth Tobacco Survey (2014) focus on knowledge about e-cigarettes. For knowledge, questions have 3 response choices (True, False, and not sure). Correct answers are scored as 1, incorrect are scored as 0, and not sure responses are also scored as 0. Total scores range from 0 to 15, with higher scores indicating better performance.
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 1 question adapted from the National Youth Tobacco Survey (2014): "Do you think you will vape or use an e-cigarette, like JUUL, in the next year?" Participants respond on a Likert scale ranging from 1 (not at all likely) to 5 (very likely).
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) after playing videogame intervention. The survey includes 1 question adapted from the National Youth Tobacco Survey (2014): "Do you think you will vape or use an e-cigarette, like JUUL, in the next year?" Participants respond on a Likert scale ranging from 1 (not at all likely) to 5 (very likely).
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 - 3 months post test survey. Participants will complete a post-survey through a secured, data collection website (Qualtrics Data Collection Software). The survey includes 1 question adapted from the National Youth Tobacco Survey (2014): "Do you think you will vape or use an e-cigarette, like JUUL, in the next year?" Participants respond on a Likert scale ranging from 1 (not at all likely) to 5 (very likely).
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 - 6 months post test survey. Participants will complete a post-survey through a secured, data collection website (Qualtrics Data Collection Software). The survey includes 1 question adapted from the National Youth Tobacco Survey (2014): "Do you think you will vape or use an e-cigarette, like JUUL, in the next year?" Participants respond on a Likert scale ranging from 1 (not at all likely) to 5 (very likely).
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) before playing the videogame intervention. The survey includes 5 questions adapted from the National Youth Tobacco Survey (2014) focus on harm perceptions about e-cigarettes. Questions have 4 choices ranging from 1 (no harm) to 4 (a lot of harm). Some items are reverse coded such that higher mean scores indicate greater perceived harm of e-cigarettes. Items were averaged into a composite scale that ranged from 1 to 4, with higher scores indicating greater perceived harm.
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 the survey through a secured, data collection website (Qualtrics Data Collection Software) after playing the videogame intervention. The survey includes 5 questions adapted from the National Youth Tobacco Survey (2014) that focus on harm perceptions about e-cigarettes. Questions have 4 choices ranging from 1 (no harm) to 4 (a lot of harm). Some items are reverse coded such that higher scores indicate greater perceived harm of e-cigarettes. Items were averaged into a composite scale that ranged from 1 to 4, with higher scores indicating greater perceived harm.
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 - 3 month post-test survey. Participants complete a survey through a secured, data collection website (Qualtrics Data Collection Software) 3 months after playing the intervention. The survey includes 5 questions adapted from the National Youth Tobacco Survey (2014) that focus on harm perceptions of e-cigarettes. Questions have 4 choices ranging from 1 (no harm) to 4 (a lot of harm). Some items are reverse coded such that higher scores indicate greater perceived harm of e-cigarettes. Items were averaged into a composite scale that ranged from 1 to 4, with higher scores indicating greater perceived harm.
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 completed a survey through a secured, data collection website (Qualtrics Data Collection Software) 6 months after playing the videogame intervention. The survey includes 5 questions adapted from the National Youth Tobacco Survey (2014) that focus on harm perceptions of e-cigarettes. Questions have 4 choices ranging from 1 (no harm) to 4 (a lot of harm). Some items are reverse coded such that higher scores indicate greater perceived harm of e-cigarettes. Items were averaged into a composite scale that ranged from 1 to 4, with higher scores indicating greater perceived harm.
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 6 questions adapted from the National Youth Tobacco Survey (2014) that focus on self-efficacy to refuse e-cigarettes. Questions are Likert scale and have 4 choices ranging from 1 (not at all sure) to 4 (definitely sure). Higher scores represent greater self-efficacy to refuse e-cigarettes across a variety of situations. Items were averaged into a composite scale that ranged from 1 to 4, with higher scores indicating greater elf-efficacy to refuse e-cigarettes.
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 completed a post-survey through a secured, data collection website (Qualtrics Data Collection Software) immediately after playing the videogame intervention. The survey includes 6 questions adapted from the National Youth Tobacco Survey (2014) that focus on self-efficacy to refuse e-cigarettes. Questions are Likert scale and have 4 choices ranging from 1 (not at all sure) to 4 (definitely sure). Higher scores represent greater self-efficacy to refuse e-cigarettes across a variety of situations. Items were averaged into a composite scale that ranged from 1 to 4, with higher scores indicating greater elf-efficacy to refuse e-cigarettes.
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 - 3 months post-test survey. Participants will completed a survey through a secured, data collection website (Qualtrics Data Collection Software) 3 months after playing the videogame intervention. The survey includes 6 questions adapted from the National Youth Tobacco Survey (2014) that focus on self-efficacy to refuse e-cigarettes. Questions are Likert scale and have 4 choices ranging from 1 (not at all sure) to 4 (definitely sure). Higher scores represent greater self-efficacy to refuse e-cigarettes across a variety of situations. Items were averaged into a composite scale that ranged from 1 to 4, with higher scores indicating greater elf-efficacy to refuse e-cigarettes.
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 - 6 months post-test survey. Participants completed a survey through a secured, data collection website (Qualtrics Data Collection Software) 6 months after playing the videogame intervention. The survey includes 6 questions adapted from the National Youth Tobacco Survey (2014) that focus on self-efficacy to refuse e-cigarettes. Questions are Likert scale and have 4 choices ranging from 1 (not at all sure) to 4 (definitely sure). Higher scores represent greater self-efficacy to refuse e-cigarettes across a variety of situations. Items were averaged into a composite scale that ranged from 1 to 4, with higher scores indicating greater elf-efficacy to refuse e-cigarettes.
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 choices ranging from strongly disagree to strongly agree. Some items were reverse coded prior to all items being averaged into a composite scale that ranged from 1 to 4, with higher scores representing greater satisfaction with gameplay experience.
Yale University
Other
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