A Virtual Reality Vaping Prevention Intervention for Adolescents

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. In Phase 1, investigators will conduct focus groups with adolescents and interviews with school staff to inform the development and implementation of the intervention.

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Key information

Conditions

Vaping Behavior Emotional Regulation Self-Control Smoking Social Behavior

Age range

12 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Yale University, New Haven, Connecticut, United States

About this study

Investigators will conduct focus groups with adolescents. 4 focus groups will focus on collecting adolescents' perceptions about e-cigarettes and students' mental health needs in general, and how they perceive the link between the 2 constructs. Participants will also play E-Invite Only VR and then convene to share their thoughts and experiences. Participants will also fill out surveys including the System Usability Scale and the Gameplay Experience Questionnaire.

Staff will review and discuss the E-Invite Only VR implementation plan and respond to the Feasibility of Implementation Plan assessment during the interviews. Investigators will work with two populations: 1) Adolescents attending 8th grade in one of our partner schools, and 2) School staff employed by a partner school.

The target user for the E-Invite Only VR intervention is 8th grade students because the game is focused on prevention. Early adolescence is known to be a critical period for the risk of nicotine dependence and the transition between middle school and high school is a period when youth might be particularly likely to experiment with substances such as e-cigarettes.

Investigators will work with school staff to ensure the E-Invite Only VR intervention is feasible to implement in schools.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

School staff:

employed by one of our partner schools
could use the enhanced intervention with students OR work directly with students at risk for e-cigarette use/mental health concerns
age greater than or equal to 18 years
English speaking

8th grade adolescents

enrolled in 8th grade in one of our partner schools
willing to engage in discussions about their experiences and perceptions related to e-cigarettes and mental health promotion
English speaking

Treatment and study plan

Primary outcomes

Acceptability of the the Videogame

Time frame: Immediately after the focus group and gameplay testing of the intervention, Day 1

The Gameplay experience questionnaire, consisting of 11 items ranging from strongly disagree to strongly agree, will be used to assess adolescents' perception of the acceptability of the videogame intervention.
System Usability Scale

Time frame: Immediately after the focus group and gameplay, Day 1

The System Usability Scale (SUS), 10 items ranging from "strongly disagree" to "strongly agree" will be completed by adolescents and school staff to access the usability of the intervention.
Feasibility of Implementation

Time frame: Immediately after interviews with school staff, Day 1

Feasibility of Implementation, consisting of 5 items ranging from "Strongly disagree" to "strongly agree" will be used to assess feasibility of the intervention.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Jan 23, 2026
Registry last updated: Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed