A Virtual Reality Videogame for E-cigarette Prevention in Teens

Not Applicable

Completed

• Conditions: E-Cig Use; Vaping
• Interventions: Other: treatment as usual; Device: videogame

• Registration Number: NCT04054765
• Lead Sponsor: Yale University

Brief Summary

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.

Detailed Description

Specific 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:

1. the preliminary impact of the intervention on e-cigarette use behaviors, knowledge, nicotine addiction knowledge, perceived addictiveness of e-cigarettes, perceived likelihood of using e-cigarettes, perceptions of harm, self-efficacy to refuse, social approval of e-cigarettes, and e-cigarette social perceptions

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 Invite Only VR on players' perception and experience of social pressure and social norm development

Study Timeline

• Study First Submitted: 2019-08-08
• Study First Submitted QC: 2019-08-08
• Study First Posted: 2019-08-13
• Study Start: 2019-10-17
• Primary Completion: 2020-06-05
• Study Completion: 2020-06-05
• Results First Submitted: 2021-04-07
• Results First Submitted QC: 2021-05-21
• Status Verified: 2021-06
• Results First Posted: 2021-06-18
• Last Update Submitted: 2021-06-23
• Last Update Posted: 2021-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 287

Inclusion Criteria

• Willing to wear a VR headset and play a video game for 45-60 minutes for 2-3 sessions and answer questions before and after playing the videogame.
• Be enrolled in Milford Middle School District

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Exclusion Criteria

• If subject does not fit the criteria above

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Teens receive treatment as usual	treatment as usual	132 adolescents receive treatment as usual, which includes regular instruction in health class regarding the dangers of e-cigarettes
Teens in the Invite Only VR videogame	videogame	155 adolescents playing the Invite Only VR intervention

Primary Outcome Measures

Name	Time	Method
Percent of Participants Who Report E-cigarette Use at 6 Months	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.

Secondary Outcome Measures

Name	Time	Method
Attitudes Towards E-cigarettes Post-test	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.
Attitudes Towards E-cigarettes Pre-test	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.
Knowledge of E-cigarettes Post-test	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.
Intentions of E-cigarettes Pre-test	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).
Perceptions Involving E-cigarettes Pretest	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.
Refuse E-cigarettes Post-test	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.
Knowledge of E-cigarettes Pre-test	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.
Intentions of E-cigarettes Post-test	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).
Refuse E-cigarettes Pre-test	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.
Perceptions Involving E-cigarettes Post-test	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.

Trial Locations

Locations (1)

Milford School District; 🇺🇸 Milford, Connecticut, United States