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临床试验/NCT07362069
NCT07362069Enrolling By Invitation不适用

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

Yale University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年11月12日最近更新:

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
40
试验地点
2
主要终点
Acceptability of the the Videogame

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

年龄范围
12 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 未提供

研究组 & 干预措施

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.

结局指标

主要结局

Acceptability of the the Videogame

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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