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临床试验/NCT07413432
NCT07413432已完成不适用

A Virtual Reality Videogame for E-cigarette and Cannabis Prevention in Teens

Yale University1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2025年9月26日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
62
试验地点
1
主要终点
Feasibility Assessed Using Change in Retention Rates

研究概览

简要总结

The goal of this study is to develop and test an adapted version of our virtual reality videogame intervention prototype, Invite Only VR, developed for middle school students, which focuses on e-cigarette and marijuana vaping prevention. The game also includes a focus on emotion regulation and healthy coping skills. To determine the preliminary impact of the intervention, investigators will collect acceptability and feasibility data from 6th-8th grade students across three Connecticut middle schools. Investigators will also collect data on participants' knowledge, harm perceptions, and intentions to vape before and after they have played the videogame intervention.

详细描述

The goal of this project is to develop and evaluate an evidence-based classroom-based e-cigarette and marijuana vaping prevention videogame for 6th to 8th grade students in three CT middle schools. To determine the preliminary impact of the intervention, investigators will measure the following : 1) students who complete the entire intervention (target outcome >90%), 2) acceptability of the intervention among 6th-8th grade students and school administration associated with delivery of the intervention (target outcome >90% report it is acceptable); 3) the intervention will be reported as feasible to implement by school administration(target outcome >90% report it is feasible); 4) students will increase knowledge of marijuana and nicotine vaping harms (target outcome pre-post knowledge and harm perceptions test score will have a statistically significant increase, 5) students will reduce their intentions to vape (target outcome pre-post intentions to vape will have a statistically significant decrease in scores). Findings from this research study will produce the first theory-driven, evidence-based, novel VR videogame intervention focused on both e-cigarette and marijuana vaping in adolescents, a key population that needs engaging interventions designed specifically for them, and will provide acceptability and preliminary efficacy data to inform a larger-scale effectiveness-implementation trial.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

入选标准

  • enrolled at a participating middle school in CT
  • speak English
  • attending 6th, 7th, or 8th grade
  • be willing to play a virtual reality videogame for 45-60 minutes/session
  • ability to provide assent or parental/guardian consent

排除标准

  • Failure to meet inclusion criteria

研究组 & 干预措施

Invite Only VR Intervention Only Group

Experimental

All participants in the study will play the virtual reality videogame intervention, Invite Only VR. The game was developed for middle school students and focuses on e-cigarette and cannabis vaping prevention. The game also includes content and skill-development related to emotion regulation and healthy coping.

干预措施: Virtual reality videogame intervention for vaping prevention (Behavioral)

结局指标

主要结局

Feasibility Assessed Using Change in Retention Rates

时间窗: From enrollment to the end of the last gameplay session, up to 1.5 hrs

Feasibility will be measured the number of participants that completed the assigned intervention.

Acceptability Assessed Via Self-reported Survey

时间窗: End of Final Gameplay Session, up to 1.5 hrs

Acceptability of the intervention is assessed via self-reported survey at the post-gameplay time point using the game experience and satisfaction questionnaire, which is a 12-item scale custom-created for this study with 4-point Likert-type responses ranging from 1 (strongly disagree) to 4 (strongly agree). Total score range 12-42. Higher scores indicate stronger agreement with the statement.

Usability of the Intervention Assessed via Self-Reported Survey

时间窗: End of Final Gameplay Session, up to 1.5 hrs

Usability of the intervention will be assessed via self-reported survey at the post-gameplay time point using the System Usability Scale (SUS), which is a 10-item scale with 5-point Likert-type responses ranging from 1 (strongly disagree) to 5 (strongly agree). Total score range 10-50. Higher scores indicate stronger agreement with the statement.

次要结局

  • Change in Intentions to Use E-cigarettes from Pre- to Post-Intervention(Baseline and immediately following the last gameplay session, up to 1.5 hrs.)
  • Change in Nicotine and Cannabis Harm Perceptions(Baseline and immediately following the last gameplay session up to 1.5 hrs.)
  • Changes in Nicotine and Cannabis Vape Knowledge(Baseline and immediately following the last gameplay session, up to 1.5 hrs.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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