A Virtual Reality E-cigarette Prevention and Emotion Regulation Intervention for Adolescents
Part of paid clinical trials in New Haven, Connecticut.
- Sponsor
- Yale University
- Study ID
- NCT07460622
- Status
- Not Yet Recruiting
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Conditions
- Adolescent Mental Health
- E-cigarette Use/Vaping Prevention
- Nicotine Dependence Prevention
Eligibility Criteria
- Sex
- ALL
- Age
- 11 Years - 15 Years
- Healthy Volunteers
- Accepted
Interventions
- Virtual Reality E-Cigarette Prevention Program — BEHAVIORALThe 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
Study Details
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.
Key Dates
- Start date
- Oct 1, 2026
- Status verified
- Mar 2026
- Primary completion
- Jun 30, 2028
- Completion
- Jun 30, 2028
Study Design
- Enrollment
- 1,251 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- PREVENTION
Arms
- Experimental: E-Invite Only VR: A Virtual Reality E-Cigarette Prevention InterventionParticipants in this arm will receive the E-Invite Only VR intervention, a school-based, virtual reality (VR) e-cigarette prevention program designed for 8th-grade students. The intervention leverages immersive VR technology and interactive gameplay to educate students about the risks of e-cigarette use, develop their refusal skills, and promote mental health awareness. Students will engage in role-playing scenarios where they practice resisting peer pressure and making informed decisions about vaping. The intervention integrates social and emotional learning (SEL) principles, focusing on emotional regulation and healthy coping strategies to reduce the likelihood of e-cigarette initiation. The VR-based intervention will be delivered over multiple class sessions, totaling approximately 2-2.5 hours of gameplay. Trained school staff and research personnel will oversee implementation during school hours.
- No Intervention: Wait-list Control (Standard Health Curriculum)Participants in this arm will receive the standard e-cigarette prevention education currently provided by their school as part of the existing health curriculum. Unlike the intervention arm, students in the control group will not have access to the E-Invite Only VR program during the study period.
Primary Outcome Measure
Number of participants E-cigarette Initiation [ Time Frame: 3, 6, and 12 months ]
Central Contacts
- Kimberly Hieftje D Associate Professor of Pediatrics, PhD12037375595
- Deepa Camenga Associate Professor of Emergency Medicine, MD
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Yale School of Medicine | New Haven | Connecticut | 06510 |
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