A Virtual Reality Vaping Prevention Intervention for Adolescents

E-cigarette Prevention and Emotion Regulation: Virtual Reality 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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Vaping

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale University
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The targeted study population is 8th grade adolescents and school staff (teachers, wellness coordinators, school counselors, and school psychologists) in participating schools.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Adolescent Focus Groups; Investigators will conduct focus groups with a sample of 8th-grade adolescents. To inform the conceptual model, investigators will ask students to describe perceptions about e-cigarettes and students' mental health needs in general, and how they perceive the link between the two constructs. Investigators will conduct interviews with 20 school staff, such as health teacher, school counselors, etc) to inform the implementation plan.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of the the Videogame	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.	Immediately after the focus group and gameplay testing of the intervention, Day 1
System Usability Scale	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.	Immediately after the focus group and gameplay, Day 1
Feasibility of Implementation	Feasibility of Implementation, consisting of 5 items ranging from "Strongly disagree" to "strongly agree" will be used to assess feasibility of the intervention.	Immediately after interviews with school staff, Day 1

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2025
• Primary Completion (Estimated): February 28, 2026
• Study Completion (Estimated): February 28, 2026

Study Registration Dates

• First Submitted: January 21, 2026
• First Submitted That Met QC Criteria: January 21, 2026
• First Posted (Actual): January 23, 2026

Study Record Updates

• Last Update Posted (Actual): January 26, 2026
• Last Update Submitted That Met QC Criteria: January 22, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: prevention; intervention; adolescents; virtual reality; emotion regulation; vaping
• Additional Relevant MeSH Terms: Behavior; Smoking; Social Behavior; Self-Control; Vaping; Emotional Regulation
• Other Study ID Numbers: 2000039342; 1R01CA294027 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Investigators will make focus group data and associated documentation available to users only under a data-sharing agreement.
• IPD Sharing Time Frame: Data will generally be available within one year of completion of the funded project period or upon acceptance of the first publication.
• IPD Sharing Access Criteria: Investigators will make focus group data and associated documentation available to users only under a data-sharing agreement that provides for (1) a commitment to using the data only for research purposes and not to identify any individual participant, (2) a commitment to securing the data using appropriate computer technology, and (3) a commitment to destroying or returning the data after analyses are completed. Data will generally be available within one year of completion of the funded project period or upon acceptance of the first publication. Data will also be available through publications and presentations at scientific meetings. Findings will be published in scientific journals. All manuscripts that arise from this proposal will be submitted to PubMed Central.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No