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 — 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

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 Intervention
    Participants 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

Locations (1)

FacilityCityStateZIPSite coordinators
Yale School of MedicineNew HavenConnecticut06510
Kimberly Hieftje Associate Professor of Pediatrics, PhD
203-737-5595

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