Trial Outcomes & Findings for A Virtual Reality Videogame for E-cigarette Prevention in Teens (NCT NCT04054765)

NCT ID: NCT04054765

Last Updated: 2021-06-25

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 287 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2021-06-25

Participant Flow

844 teens in Milford Schools met eligibility requirements. 557 were excluded for failure to provide signed parental consent for inclusion in the study

Participant milestones

Measure	Teens in the Invite Only VR Videogame 155 adolescents played the Invite Only VR intervention for 2-4 sessions for approximately 40 minutes per session. These 2-4 play sessions play took place following the pre-test at baseline. The post-test was administered immediately after the final play session. videogame: Invite Only VR videogame Invite Only VR is a VR, story-based videogame intervention that teaches adolescents aged 11 to 17 years about the health risks of using e-cigarettes while providing a virtual environment to practice refusing peer pressure to vape e-cigarettes.	Teens Receive Treatment as Usual 132 adolescents receive treatment as usual This includes attending regular health class in public school in which the dangers of e-cigarettes are discussed. treatment as usual: treatment as usual
Baseline STARTED	155	132
Baseline COMPLETED	150	129
Baseline NOT COMPLETED	5	3
Post-Gameplay / 1-week Follow up STARTED	150	129
Post-Gameplay / 1-week Follow up COMPLETED	142	126
Post-Gameplay / 1-week Follow up NOT COMPLETED	8	3
3-month Follow up STARTED	142	126
3-month Follow up COMPLETED	142	123
3-month Follow up NOT COMPLETED	0	3
6-month Follow up STARTED	142	123
6-month Follow up COMPLETED	110	91
6-month Follow up NOT COMPLETED	32	32

Reasons for withdrawal

Measure	Teens in the Invite Only VR Videogame 155 adolescents played the Invite Only VR intervention for 2-4 sessions for approximately 40 minutes per session. These 2-4 play sessions play took place following the pre-test at baseline. The post-test was administered immediately after the final play session. videogame: Invite Only VR videogame Invite Only VR is a VR, story-based videogame intervention that teaches adolescents aged 11 to 17 years about the health risks of using e-cigarettes while providing a virtual environment to practice refusing peer pressure to vape e-cigarettes.	Teens Receive Treatment as Usual 132 adolescents receive treatment as usual This includes attending regular health class in public school in which the dangers of e-cigarettes are discussed. treatment as usual: treatment as usual
Baseline Withdrawal by Subject	5	3
Post-Gameplay / 1-week Follow up Withdrawal by Subject	8	3
3-month Follow up Withdrawal by Subject	0	3
6-month Follow up Lost to Follow-up	32	32

Baseline Characteristics

A Virtual Reality Videogame for E-cigarette Prevention in Teens

Baseline characteristics by cohort

Measure	Teens in the Invite Only VR Videogame n=155 Participants 155 adolescents playing the Invite Only VR intervention videogame: Invite Only VR videogame	Teens Receive Treatment as Usual n=132 Participants 132 adolescents receive treatment as usual treatment as usual: treatment as usual	Total n=287 Participants Total of all reporting groups
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	11 Participants n=5 Participants	8 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) White	109 Participants n=5 Participants	90 Participants n=7 Participants	199 Participants n=5 Participants
Race (NIH/OMB) More than one race	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	11 Participants n=5 Participants	6 Participants n=7 Participants	17 Participants n=5 Participants
Region of Enrollment United States	155 Participants n=5 Participants	132 Participants n=7 Participants	287 Participants n=5 Participants
Current e-cigarette/JUUL user (Y/N)	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Asian	12 Participants n=5 Participants	17 Participants n=7 Participants	29 Participants n=5 Participants
Age, Categorical <=18 years	155 Participants n=5 Participants	132 Participants n=7 Participants	287 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	12.4 years STANDARD_DEVIATION .56 • n=5 Participants	12.5 years STANDARD_DEVIATION .59 • n=7 Participants	12.45 years STANDARD_DEVIATION .57 • n=5 Participants
Sex: Female, Male Female	81 Participants n=5 Participants	49 Participants n=7 Participants	130 Participants n=5 Participants
Sex: Female, Male Male	74 Participants n=5 Participants	83 Participants n=7 Participants	157 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Teens in the Invite Only VR Videogame n=110 Participants 155 adolescents playing the Invite Only VR intervention videogame: Invite Only VR videogame	Teens Receive Treatment as Usual n=91 Participants 132 adolescents receive treatment as usual treatment as usual: treatment as usual
Percent of Participants Who Report E-cigarette Use at 6 Months	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Teens in the Invite Only VR Videogame n=150 Participants 155 adolescents playing the Invite Only VR intervention videogame: Invite Only VR videogame	Teens Receive Treatment as Usual n=129 Participants 132 adolescents receive treatment as usual treatment as usual: treatment as usual
Attitudes Towards E-cigarettes Pre-test	3.38 units on a scale Standard Deviation .46	3.21 units on a scale Standard Deviation .54

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Teens in the Invite Only VR Videogame n=142 Participants 155 adolescents playing the Invite Only VR intervention videogame: Invite Only VR videogame	Teens Receive Treatment as Usual n=126 Participants 132 adolescents receive treatment as usual treatment as usual: treatment as usual
Attitudes Towards E-cigarettes Post-test	3.37 units on a scale Standard Deviation .49	3.24 units on a scale Standard Deviation .54

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Teens in the Invite Only VR Videogame n=142 Participants 155 adolescents playing the Invite Only VR intervention videogame: Invite Only VR videogame	Teens Receive Treatment as Usual n=123 Participants 132 adolescents receive treatment as usual treatment as usual: treatment as usual
Attitudes Towards E-cigarettes Post-test	3.36 units on a scale Standard Deviation .5	3.28 units on a scale Standard Deviation .55

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Teens in the Invite Only VR Videogame n=110 Participants 155 adolescents playing the Invite Only VR intervention videogame: Invite Only VR videogame	Teens Receive Treatment as Usual n=91 Participants 132 adolescents receive treatment as usual treatment as usual: treatment as usual
Attitudes Towards E-cigarettes Post-test	3.48 units on a scale Standard Deviation .44	3.28 units on a scale Standard Deviation .58

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Teens in the Invite Only VR Videogame n=150 Participants 155 adolescents playing the Invite Only VR intervention videogame: Invite Only VR videogame	Teens Receive Treatment as Usual n=129 Participants 132 adolescents receive treatment as usual treatment as usual: treatment as usual
Knowledge of E-cigarettes Pre-test	11.29 score on a scale Standard Deviation 1.91	10.33 score on a scale Standard Deviation 2.57

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Teens in the Invite Only VR Videogame n=142 Participants 155 adolescents playing the Invite Only VR intervention videogame: Invite Only VR videogame	Teens Receive Treatment as Usual n=126 Participants 132 adolescents receive treatment as usual treatment as usual: treatment as usual
Knowledge of E-cigarettes Post-test	13.97 score on a scale Standard Deviation 1.27	10.45 score on a scale Standard Deviation 2.92

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Teens in the Invite Only VR Videogame n=142 Participants 155 adolescents playing the Invite Only VR intervention videogame: Invite Only VR videogame	Teens Receive Treatment as Usual n=123 Participants 132 adolescents receive treatment as usual treatment as usual: treatment as usual
Knowledge of E-cigarettes Post-test	13.6 score on a scale Standard Deviation 1.29	11.17 score on a scale Standard Deviation 2.88

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Teens in the Invite Only VR Videogame n=110 Participants 155 adolescents playing the Invite Only VR intervention videogame: Invite Only VR videogame	Teens Receive Treatment as Usual n=91 Participants 132 adolescents receive treatment as usual treatment as usual: treatment as usual
Knowledge of E-cigarettes Post-test	13.39 score on a scale Standard Deviation 1.96	11.02 score on a scale Standard Deviation 2.78

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Teens in the Invite Only VR Videogame n=150 Participants 155 adolescents playing the Invite Only VR intervention videogame: Invite Only VR videogame	Teens Receive Treatment as Usual n=129 Participants 132 adolescents receive treatment as usual treatment as usual: treatment as usual
Intentions of E-cigarettes Pre-test	1.12 units on a scale Standard Deviation .44	1.25 units on a scale Standard Deviation .55

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Teens in the Invite Only VR Videogame n=142 Participants 155 adolescents playing the Invite Only VR intervention videogame: Invite Only VR videogame	Teens Receive Treatment as Usual n=126 Participants 132 adolescents receive treatment as usual treatment as usual: treatment as usual
Intentions of E-cigarettes Post-test	1.08 units on a scale Standard Deviation .27	1.26 units on a scale Standard Deviation .51

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Teens in the Invite Only VR Videogame n=142 Participants 155 adolescents playing the Invite Only VR intervention videogame: Invite Only VR videogame	Teens Receive Treatment as Usual n=123 Participants 132 adolescents receive treatment as usual treatment as usual: treatment as usual
Intentions of E-cigarettes Post-test	1.18 units on a scale Standard Deviation .41	1.28 units on a scale Standard Deviation .56

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Teens in the Invite Only VR Videogame n=110 Participants 155 adolescents playing the Invite Only VR intervention videogame: Invite Only VR videogame	Teens Receive Treatment as Usual n=91 Participants 132 adolescents receive treatment as usual treatment as usual: treatment as usual
Intentions of E-cigarettes Post-test	1.11 units on a scale Standard Deviation .32	1.21 units on a scale Standard Deviation .44

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Teens in the Invite Only VR Videogame n=150 Participants 155 adolescents playing the Invite Only VR intervention videogame: Invite Only VR videogame	Teens Receive Treatment as Usual n=129 Participants 132 adolescents receive treatment as usual treatment as usual: treatment as usual
Perceptions Involving E-cigarettes Pretest	2.56 units on a scale Standard Deviation .29	2.57 units on a scale Standard Deviation .3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Teens in the Invite Only VR Videogame n=142 Participants 155 adolescents playing the Invite Only VR intervention videogame: Invite Only VR videogame	Teens Receive Treatment as Usual n=126 Participants 132 adolescents receive treatment as usual treatment as usual: treatment as usual
Perceptions Involving E-cigarettes Post-test	2.69 units on a scale Standard Deviation .24	2.56 units on a scale Standard Deviation .35

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Teens in the Invite Only VR Videogame n=142 Participants 155 adolescents playing the Invite Only VR intervention videogame: Invite Only VR videogame	Teens Receive Treatment as Usual n=123 Participants 132 adolescents receive treatment as usual treatment as usual: treatment as usual
Perceptions Involving E-cigarettes Post-test	2.65 units on a scale Standard Deviation .19	2.57 units on a scale Standard Deviation .3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Teens in the Invite Only VR Videogame n=110 Participants 155 adolescents playing the Invite Only VR intervention videogame: Invite Only VR videogame	Teens Receive Treatment as Usual n=91 Participants 132 adolescents receive treatment as usual treatment as usual: treatment as usual
Perceptions Involving E-cigarettes Post-test	2.64 units on a scale Standard Deviation .2	2.55 units on a scale Standard Deviation .23

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Teens in the Invite Only VR Videogame n=150 Participants 155 adolescents playing the Invite Only VR intervention videogame: Invite Only VR videogame	Teens Receive Treatment as Usual n=129 Participants 132 adolescents receive treatment as usual treatment as usual: treatment as usual
Refuse E-cigarettes Pre-test	3.87 units on a scale Standard Deviation .31	3.73 units on a scale Standard Deviation .62

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Teens in the Invite Only VR Videogame n=142 Participants 155 adolescents playing the Invite Only VR intervention videogame: Invite Only VR videogame	Teens Receive Treatment as Usual n=126 Participants 132 adolescents receive treatment as usual treatment as usual: treatment as usual
Refuse E-cigarettes Post-test	3.89 units on a scale Standard Deviation .37	3.72 units on a scale Standard Deviation .62

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Teens in the Invite Only VR Videogame n=142 Participants 155 adolescents playing the Invite Only VR intervention videogame: Invite Only VR videogame	Teens Receive Treatment as Usual n=123 Participants 132 adolescents receive treatment as usual treatment as usual: treatment as usual
Refuse E-cigarettes Post-test	3.9 units on a scale Standard Deviation .24	3.77 units on a scale Standard Deviation .53

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Teens in the Invite Only VR Videogame n=110 Participants 155 adolescents playing the Invite Only VR intervention videogame: Invite Only VR videogame	Teens Receive Treatment as Usual n=91 Participants 132 adolescents receive treatment as usual treatment as usual: treatment as usual
Refuse E-cigarettes Post-test	3.9 units on a scale Standard Deviation .23	3.83 units on a scale Standard Deviation .44

OTHER_PRE_SPECIFIED outcome

Timeframe: immediately after gameplay

Population: Only teens in the Invite Only VR Videogame Group responded to this survey.

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.

Outcome measures

Measure	Teens in the Invite Only VR Videogame n=150 Participants 155 adolescents playing the Invite Only VR intervention videogame: Invite Only VR videogame	Teens Receive Treatment as Usual 132 adolescents receive treatment as usual treatment as usual: treatment as usual
Satisfaction With Gameplay Experience - Experimental Only	3.08 units on a scale Standard Deviation .59	—

Adverse Events

Teens in the Invite Only VR Videogame

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Teens Receive Treatment as Usual

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Kimberly Hieftje

play4REAL XR Lab at the Yale School of Medicine

Phone: 2037872402

Email: kimberly.hieftje@yale.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place