A Virtual Reality E-cigarette Prevention and Emotion Regulation Intervention for Adolescents

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age11-15
SponsorYale University

About this trial

This study will examine E-Invite Only VR, a novel school-based universal e-cigarette prevention intervention that uses virtual reality (VR) to deliver prevention and emotion regulation skills-building content to middle school students in real-world classrooms. If successful, E-invite Only VR has the potential to prevent adolescents from experiencing a multitude of poor health outcomes related to nicotine vaping, including cancer.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Enrolled in the 8th grade in one of the 20 partner middle schools (8 in Connecticut, 12 in Massachusetts).

Willing to participate in a VR videogame for approximately 45 minutes per session, accumulating 2-2.5 hours of total gameplay across multiple class periods.

Able to provide assent and obtain parental/guardian consent before participating in the study.

Disqualifiers

Students not enrolled in 8th grade at one of the participating schools.

Students who are unwilling or unable to participate in VR gameplay for the required duration.

Students who cannot provide assent or do not have parental/guardian consent to participate .

Trial design

Design model

Parallel

Treatments tested in this trial

  • Virtual Reality E-Cigarette Prevention Program

    Behavioral

    The E-Invite Only VR intervention is a school-based, virtual reality (VR) e-cigarette prevention program designed for 8th-grade students. It is an enhanced version of the Invite Only VR game, incorporating mental health promotion content alongside e-cigarette prevention education. The intervention leverages interactive gameplay to build emotion regulation skills and increase students' ability to resist peer pressure to use e-cigarettes. It aligns with behavior change theories, including the Theory of Planned Behavior and Social Cognitive Theory, to improve knowledge, harm perceptions, and self-efficacy related to vaping prevention

Treatment groups

1,251 Participants
are divided into 2 treatment groups
Group A: E-Invite Only VR: A Virtual Reality E-Cigarette Prevention InterventionExperimental treatment 1 intervention
Group B: Wait-list Control (Standard Health Curriculum)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

Number of participants E-cigarette Initiation

E-cigarette use is defined as answering "yes" to the question: "Have you ever used an e-cigarette, even once or twice?" Participants will be classified as having initiated e-cigarette use if they report any past use at any of these time points.

Time frame
3, 6, and 12 months

Secondary outcomes

1

E-Cigarette Knowledge

Measures changes in students' knowledge of e-cigarettes, including nicotine addiction, marketing tactics, laws, and regulations. Items are summed to create a total knowledge score ranging from 0 to 15, with higher scores indicating greater knowledge

Time frame
Baseline, 3, 6, and 12 months post-intervention
2

E-Cigarette Harm Perceptions

All harm perception items use a 5-point scale coded from 1 (not at all harmful) to 5 (extremely harmful). The addiction likelihood items use a parallel 5-point scale coded from 1 (not at all likely) to 5 (extremely likely). Items may be examined individually or combined into composite scores with separate subscales for harm perceptions (Items 1, 2, 3, and 5) and addiction likelihood (Items 4 and 6). Higher scores indicate stronger perceptions of harm or addiction risk.

Time frame
Baseline, 3, 6, and 12 months post-intervention
3

E-Cigarette Social Perceptions

The first two items use a 4-point Likert scale coded from 1 (strongly/completely disagree) to 4 (strongly/completely agree). The perceived peer acceptability item is coded from 1 (not acceptable) to 4 (completely acceptable). The peer influence item is coded from 1 (friends would tell you not to take a hit) to 4 (friends would exclude you for not taking a hit), with higher scores indicating stronger perceived social pressure to vape. The social media exposure item is coded from 1 (content posted by Public Health Campaigns) to 5 (content posted by e-cigarette brands or sellers), with higher scores reflecting greater exposure to promotional sources rather than educational sources and close peers. Items may be analyzed individually or summed to create a composite index of social norms and perceived social influences related to e-cigarette use, with higher scores indicating more permissive or pro-vaping social perceptions.

Time frame
Baseline, 3, 6, and 12 months post-intervention
4

Healthy Attitudes Toward E-Cigarette Use

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
Baseline, 3, 6, and 12 months post-intervention

Other outcomes

Sponsors and contacts

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Yale University

Lead sponsor

National Cancer Institute (NCI)

Collaborator

This trial is not recruiting at the moment. You can still explore other options: