A Virtual Reality Videogame for E-cigarette Prevention in Teens

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.

Study Overview

• Status: Completed
• Conditions: Vaping; E-Cig Use
• Intervention / Treatment: Device: videogame; Other: treatment as usual

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 Type: Interventional
• Enrollment (Actual): 287
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Milford, Connecticut, United States, 06460
      • Milford School District

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 17 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Exclusion Criteria:

• If subject does not fit the criteria above

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Teens in the Invite Only VR videogame; 155 adolescents playing the Invite Only VR intervention	Device: videogame; Invite Only VR videogame
OTHER: Teens receive treatment as usual; 132 adolescents receive treatment as usual, which includes regular instruction in health class regarding the dangers of e-cigarettes	Other: treatment as usual; treatment as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of Participants Who Report E-cigarette Use at 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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attitudes Towards E-cigarettes Pre-test	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.	baseline
Attitudes Towards E-cigarettes Post-test	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.	immediately after gameplay is completed
Attitudes Towards E-cigarettes Post-test	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.	3 months after gameplay is completed
Attitudes Towards E-cigarettes Post-test	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.	6 months after gameplay is completed
Knowledge of E-cigarettes Pre-test	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.	baseline
Knowledge of E-cigarettes Post-test	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.	immediately after gameplay
Knowledge of E-cigarettes Post-test	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.	3 months after gameplay
Knowledge of E-cigarettes Post-test	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.	6 months after gameplay
Intentions of E-cigarettes Pre-test	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).	baseline
Intentions of E-cigarettes Post-test	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).	immediately after gameplay
Intentions of E-cigarettes Post-test	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).	3 months after gameplay
Intentions of E-cigarettes Post-test	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).	6 months after gameplay
Perceptions Involving E-cigarettes Pretest	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.	baseline
Perceptions Involving E-cigarettes Post-test	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.	immediately after gameplay is completed
Perceptions Involving E-cigarettes Post-test	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.	3 months after gameplay is completed
Perceptions Involving E-cigarettes Post-test	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.	6 months after gameplay is completed
Refuse E-cigarettes Pre-test	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.	baseline
Refuse E-cigarettes Post-test	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.	immediately after gameplay
Refuse E-cigarettes Post-test	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.	3 months after gameplay
Refuse E-cigarettes Post-test	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.	6 months after gameplay

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction With Gameplay Experience - Experimental Only	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.	immediately after gameplay

Collaborators and Investigators

• Sponsor: Yale University

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 17, 2019
• Primary Completion (ACTUAL): June 5, 2020
• Study Completion (ACTUAL): June 5, 2020

Study Registration Dates

• First Submitted: August 8, 2019
• First Submitted That Met QC Criteria: August 8, 2019
• First Posted (ACTUAL): August 13, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 25, 2021
• Last Update Submitted That Met QC Criteria: June 23, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: prevention; intervention
• Other Study ID Numbers: 2000025177

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No