E-cigarette Prevention and Emotion Regulation: Virtual Reality Intervention for Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,251
- 试验地点
- 1
- 主要终点
- Number of participants E-cigarette Initiation
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. If successful, E-invite Only VR has the potential to prevent adolescents from experiencing a multitude of poor health outcomes related to nicotine vaping, including cancer.
详细描述
After the 12-month follow-up period, schools in the control arm will receive access to the E-Invite Only VR intervention, allowing students and staff to utilize the program as part of their regular health education curriculum.
The clinical trial portion of this study will be informed by preliminary focus groups and surveys.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 11 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Enrolled in the 8th grade in one of the 20 partner middle schools (8 in Connecticut, 12 in Massachusetts).
- •Willing to participate in a VR videogame for approximately 45 minutes per session, accumulating 2-2.5 hours of total gameplay across multiple class periods.
- •Able to provide assent and obtain parental/guardian consent before participating in the study.
排除标准
- •Students not enrolled in 8th grade at one of the participating schools.
- •Students who are unwilling or unable to participate in VR gameplay for the required duration.
- •Students who cannot provide assent or do not have parental/guardian consent to participate .
研究组 & 干预措施
E-Invite Only VR: A Virtual Reality E-Cigarette Prevention Intervention
Participants in this arm will receive the E-Invite Only VR intervention, a school-based, virtual reality (VR) e-cigarette prevention program designed for 8th-grade students. The intervention leverages immersive VR technology and interactive gameplay to educate students about the risks of e-cigarette use, develop their refusal skills, and promote mental health awareness.
Students will engage in role-playing scenarios where they practice resisting peer pressure and making informed decisions about vaping. The intervention integrates social and emotional learning (SEL) principles, focusing on emotional regulation and healthy coping strategies to reduce the likelihood of e-cigarette initiation.
The VR-based intervention will be delivered over multiple class sessions, totaling approximately 2-2.5 hours of gameplay. Trained school staff and research personnel will oversee implementation during school hours.
干预措施: Virtual Reality E-Cigarette Prevention Program (Behavioral)
Wait-list Control (Standard Health Curriculum)
Participants in this arm will receive the standard e-cigarette prevention education currently provided by their school as part of the existing health curriculum. Unlike the intervention arm, students in the control group will not have access to the E-Invite Only VR program during the study period.
结局指标
主要结局
Number of participants E-cigarette Initiation
时间窗: 3, 6, and 12 months
E-cigarette use is defined as answering "yes" to the question: "Have you ever used an e-cigarette, even once or twice?" Participants will be classified as having initiated e-cigarette use if they report any past use at any of these time points.
次要结局
- E-Cigarette Knowledge(Baseline, 3, 6, and 12 months post-intervention)
- E-Cigarette Harm Perceptions(Baseline, 3, 6, and 12 months post-intervention)
- E-Cigarette Social Perceptions(Baseline, 3, 6, and 12 months post-intervention)
- Healthy Attitudes Toward E-Cigarette Use(Baseline, 3, 6, and 12 months post-intervention)
- Self-Efficacy for E-Cigarette Refusal(Baseline, 3, 6, and 12 months post-intervention)
- Difficulties in Emotion Regulation Scale - Short Form (DERS-16)(Baseline, 3, 6, and 12 months post-intervention)
- Coping Skills- Brief COPE Inventory(Baseline, 3, 6, and 12 months post-intervention)
- Intention to Use E-Cigarettes- Pierce Susceptibility Measure(Baseline, 3, 6, and 12 months post-intervention)