Adolescent Mental Health, E-cigarette Use/Vaping Prevention, Nicotine Dependence Prevention
Conditions
Keywords
E-cigarette prevention, Vaping prevention, Nicotine addiction prevention, Virtual reality intervention, School-based prevention program, Mental health and substance use, Digital health intervention, emotion regulation skills
Brief summary
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.
Detailed description
After the 12-month follow-up period, schools in the control arm will receive access to the E-Invite Only VR intervention, allowing students and staff to utilize the program as part of their regular health education curriculum. The clinical trial portion of this study will be informed by preliminary focus groups and surveys.
Interventions
BEHAVIORALVirtual Reality E-Cigarette Prevention Program
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
Sponsors
Yale University
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
11 Years to 15 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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 .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants E-cigarette Initiation | 3, 6, and 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| E-Cigarette Knowledge | Baseline, 3, 6, and 12 months post-intervention | 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 |
| E-Cigarette Harm Perceptions | Baseline, 3, 6, and 12 months post-intervention | 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. |
| E-Cigarette Social Perceptions | Baseline, 3, 6, and 12 months post-intervention | 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. |
| Healthy Attitudes Toward E-Cigarette Use | Baseline, 3, 6, and 12 months post-intervention | 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. |
| Self-Efficacy for E-Cigarette Refusal | Baseline, 3, 6, and 12 months post-intervention | Assesses students' confidence in resisting peer pressure to use e-cigarettes. Responses are scored on a 4-point scale ranging from 1 (Not at all sure) to 4 (Very sure). Each item reflects a distinct situation in which students may encounter opportunities or pressure to vape. Scores are summed across the eight items to create a total refusal self-efficacy score, with higher scores indicating greater confidence in the ability to refuse an e-cigarette across a range of social and emotional contexts. |
| Difficulties in Emotion Regulation Scale - Short Form (DERS-16) | Baseline, 3, 6, and 12 months post-intervention | Measures students' confidence in implementing mental health promotion skills, including accessing support services. Total scores range from 16 to 80. Higher scores indicate greater difficulties with emotion regulation across domains such as nonacceptance, goal-directed behavior, impulse control, awareness, clarity, and access to regulation strategies |
| Coping Skills- Brief COPE Inventory | Baseline, 3, 6, and 12 months post-intervention | Evaluates the extent to which students apply adaptive coping strategies and emotion regulation skills in response to stress and social pressures. The reduced item set includes one item from each of the following Brief COPE subscales: self-distraction, active coping, denial, substance use, positive reframing, emotional support, religion, acceptance, venting, planning, and humor. Subscale scores range from 1 to 4, with higher scores indicating more frequent use of that coping strategy. |
| Intention to Use E-Cigarettes- Pierce Susceptibility Measure | Baseline, 3, 6, and 12 months post-intervention | Measures students' susceptibility to future e-cigarette use using a validated measure assessing intention and curiosity about vaping. Total scores range from 3 to 12. Higher scores indicate greater intention or openness to future e-cigarette use. |
Countries
United States
Contacts
CONTACTKimberly Hieftje D Associate Professor of Pediatrics, PhD
CONTACTDeepa Camenga Associate Professor of Emergency Medicine, MD
PRINCIPAL_INVESTIGATORKimberly Hieftje D Associate Professor of Pediatrics, PhD
Yale University
PRINCIPAL_INVESTIGATORDeepa Camenga Associate Professor of Emergency Medicine, MD
Yale University
Outcome results
None listed