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Clinical Trials/NCT07362069
NCT07362069Enrolling By InvitationNot Applicable

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

Yale University2 sites in 1 country40 target enrollmentStarted: November 12, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Enrolling By Invitation
Enrollment
40
Locations
2
Primary Endpoint
Acceptability of the the Videogame

Study Overview

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

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 Design

Study Type
Observational
Observational Model
Other
Time Perspective
Other

Eligibility Criteria

Ages
12 Years to 15 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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

Exclusion Criteria

  • Not provided

Arms & Interventions

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.

Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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