Virtual Reality for the Prevention and Cessation of Nicotine Vaping in Youth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 2
- 主要终点
- Engagement with the VR program
研究概览
简要总结
Many youth are addicted to nicotine due to increased nicotine vaping (e.g., e-cigarettes). Unfortunately, there are no effective interventions to help teens quit vaping. In addition, existing vaping prevention programs have limited effectiveness because teens have reported that existing available interventions are out of touch with teen's culture and are not appealing to the intended audience. Therefore, to be effective, a vaping intervention must be acceptable, appealing, and engaging to teens, and most importantly, it should be designed to be channeled into an existing infrastructure such as the school setting.
The investigators' research group has designed a vaping prevention and cessation intervention that is implemented as a VR game for high school teens. The overall objective of this research is to assess the acceptability, feasibility, and preliminary efficacy of the VR experience among high school students in two high schools in Boston.
详细描述
The investigators will conduct a randomized trial of high school students (freshman to seniors) in the Boston area to determine feasibility, satisfaction, and preliminary efficacy of the VR-based vaping cessation and prevention game. Students will be randomized by class to either receive the Virtual Reality (VR) program (experimental condition) or control condition (questionnaire assessment only). There will be three VR sessions played at school during a health class. Participants in the VR condition will also engage in a gamified home-based component on their smartphone, in order to reinforce skills learned in the school-based VR experience.
Seven high school classes across two high schools will be randomized to VR intervention or assessment only. Health classes in each high school will be randomly assigned using a 1:3 threshold probability using a random digit generator. Participants will be enrolled in the study for approximately 6 weeks. In the first 3 weeks, participants will engage in the VR game experience once per week during their classes. In the fourth and fifth week, participants may make up any VR game session that they missed because of absence (e.g., illness). At week 6, participants will complete the follow-up questionnaire assessments.
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
- 13 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Students enrolled at Everett and Quincy High Schools (freshmen, sophomores, juniors, and seniors).
- •Students in Health class
- •Child assents
排除标准
- •Teacher indicates that participation is not appropriate for the student (e.g., severe mental illness; visual or auditory disability; medical issue)
- •Parent(s)/guardian(s) opt student out of the study.
- •Prone to motion sickness or seizures.
- •Visual impairments that would preclude playing VR or otherwise unable to use VR device.
结局指标
主要结局
Engagement with the VR program
时间窗: 5 weeks
Experimental condition arm. Playing time in minutes objectively measured by the program software; higher values mean a better outcome
Awareness of vaping
时间窗: 5 weeks
Experimental condition arm. Self-report awareness adapted from the Mobile App Rating Scale (MARS). Score range 1 - 5; higher values mean a better outcome
Gameplay experience and satisfaction
时间窗: 5 weeks
Experimental condition arm. Scores on a scale assessing the gameplay experience. Score range 1 - 4; higher values mean a better outcome
Satisfaction with the VR game
时间窗: 5 weeks
Experimental condition arm. Self-report star rating of the VR game (1 to 5 stars); higher values mean a better outcome
Knowledge of vaping
时间窗: 5 weeks
Experimental condition arm Self-report knowledge adapted from the Mobile App Rating Scale (MARS). Score range 1 - 5; higher values mean a better outcome
Attitudes towards vaping
时间窗: 5 weeks
Experimental condition arm. Self-report attitudes towards vaping adapted from the Mobile App Rating Scale (MARS). Score range 1 - 5; higher values mean a better outcome
Help seeking
时间窗: 5 weeks
Experimental condition arm. Self-report help seeking for vaping behaviors adapted from the Mobile App Rating Scale (MARS). Score range 1 - 5; higher values mean a better outcome
Intention to change
时间窗: 5 weeks
Experimental condition arm. Self-report intention to change vaping behaviors adapted from the Mobile App Rating Scale (MARS). Score range 1 - 5; higher values mean a better outcome
次要结局
- Confidence in avoiding vaping(5 weeks)
- Motivation to quit (or avoid) vaping within the next 30-days(5 weeks)
- Past 7-days vaping frequency(5 weeks)
- Positive affect(5 weeks)
- Intention to connect with vaping cessation resources(5 weeks)
- Frequency of current vaping(5 weeks)
- Motivation to quit (or avoid) vaping(5 weeks)
- Intention to try vaping (or quit vaping)(5 weeks)
- Negative affect(5 weeks)
- Quit vaping attempts(5 weeks)
- Past 30-days vaping frequency(5 weeks)
- Self-efficacy to resist vaping(5 weeks)
- Resilience(5 weeks)
- Tolerability of the VR game(5 weeks)
- Emotion Regulation and Coping(5 weeks)
- Connection with vaping cessation resources(5 weeks)