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

February 11, 2026 updated by: Yale University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Invite Only VR Intervention Only Group
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.
Behavioral: Virtual reality videogame intervention for vaping prevention
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of the last gameplay session, up to 1.5 hrs
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.
End of Final Gameplay Session, up to 1.5 hrs
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.
End of Final Gameplay Session, up to 1.5 hrs

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and immediately following the last gameplay session, up to 1.5 hrs.
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.
Baseline and immediately following the last gameplay session up to 1.5 hrs.
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.
Baseline and immediately following the last gameplay session, up to 1.5 hrs.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

CT Department of Public Health

Investigators

  • Principal Investigator: Deepa Camenga, MD, Yale University
  • Principal Investigator: Kimberly Hieftje, PhD, Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 26, 2025

Primary Completion (Actual)

December 15, 2025

Study Completion (Actual)

December 30, 2025

Study Registration Dates

First Submitted

October 20, 2025

First Submitted That Met QC Criteria

February 11, 2026

First Posted (Actual)

February 17, 2026

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 11, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000025177_sub3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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