A Virtual Reality E-cigarette Prevention and Emotion Regulation Intervention for Adolescents (NCT07460622) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Virtual Reality E-cigarette Prevention and Emotion Regulation Intervention for Adolescents
United States1,251 participantsStarted 2026-10-01
Plain-language 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.
Who can participate
Age range
11 Years – 15 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 .
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants E-cigarette Initiation
Timeframe: 3, 6, and 12 months
Trial details
NCT IDNCT07460622
SponsorYale University
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2028-06
Contact for this trial
Kimberly Hieftje D Associate Professor of Pediatrics, PhD