NCT07413432

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 26, 2025

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

October 20, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 17, 2026

Completed
Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

3 months

First QC Date

October 20, 2025

Last Update Submit

February 11, 2026

Conditions

Keywords

vapingcannabispreventionvideogamevirtual realityadolescentsemotion regulation

Outcome Measures

Primary Outcomes (3)

  • Feasibility Assessed Using Change in Retention Rates

    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

    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

    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 Outcomes (3)

  • 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.

Study Arms (1)

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.

Behavioral: Virtual reality videogame intervention for vaping prevention

Interventions

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

Also known as: Invite Only VR
Invite Only VR Intervention Only Group

Eligibility Criteria

Age11 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale School of Medicine

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Marijuana AbuseVapingEmotional Regulation

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersSmokingBehaviorSelf-ControlSocial Behavior

Study Officials

  • Kimberly Hieftje, PhD

    Yale University

    PRINCIPAL INVESTIGATOR
  • Deepa Camenga, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Single-group pre-post quasi-experimental study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2025

First Posted

February 17, 2026

Study Start

September 26, 2025

Primary Completion

December 15, 2025

Study Completion

December 30, 2025

Last Updated

February 17, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations