E-cigarette Prevention and Emotion Regulation: Virtual Reality Intervention for Adolescents
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Yale University
- 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