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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yale University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
CT Department of Public Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 26, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 20, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 17, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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