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Completed

NCT Number: NCT07413432

A Virtual Reality Game to Prevent E-cigarette and Cannabis Vaping

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.

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Key information

Conditions

Cannabis Behavior Chemically-Induced Disorders Emotion Regulation Emotional Regulation Marijuana Abuse Mental Disorders Self-Control Smoking Social Behavior Substance-Related Disorders Vaping

Age range

11 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale School of Medicine

New Haven, Connecticut, 06510, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Failure to meet inclusion criteria

Treatment and study plan

Virtual reality videogame intervention for vaping prevention

Behavioral

Invite Only VR is an immersive virtual reality game designed to help adolescents build knowledge, awareness, and refusal skills around vaping through interactive, story-based social scenarios. The latest version expands its focus to include both nicotine and cannabis vaping, offering players realistic opportunities to navigate peer pressure and practice informed decision-making

Other names: Invite Only VR

Primary outcomes

  1. Feasibility Assessed Using Change in Retention Rates

    Time frame: 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.

  2. Acceptability Assessed Via Self-reported Survey

    Time frame: 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.

  3. Usability of the Intervention Assessed via Self-Reported Survey

    Time frame: 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.

Secondary outcomes

  1. Change in Intentions to Use E-cigarettes from Pre- to Post-Intervention

    Time frame: Baseline and immediately following the last gameplay session, up to 1.5 hrs.

    Changes in intentions to use e-cigarettes will be assessed using the Pierce Susceptibility Measure, at the post-gameplay time point which is a 4-item scale with 4-point Likert-type responses ranging from 1 (Definitely yes) to 4 (Definitely not). Total score range 4-16. Higher scores indicate greater intentions to use e-cigarettes.

  2. Change in Nicotine and Cannabis Harm Perceptions

    Time frame: Baseline and immediately following the last gameplay session up to 1.5 hrs.

    Change in nicotine and cannabis harm perceptions will be assessed using a 6-item survey created by the research team using a 5-point Likert scale. Total score range is 6-30. Lower scores indicate low harm perceptions.

  3. Changes in Nicotine and Cannabis Vape Knowledge

    Time frame: Baseline and immediately following the last gameplay session, up to 1.5 hrs.

    Changes in nicotine and cannabis vape knowledge will be assessed using an 8-item survey created by the research team. Responses include True, False, and I Don't Know.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • CT Department of Public Health

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 17, 2026
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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