A Virtual Reality E-cigarette Prevention and Emotion Regulation Intervention for Adolescents

E-cigarette Prevention and Emotion Regulation: Virtual Reality Intervention for Adolescents

This study will examine E-Invite Only VR, a novel school-based universal e-cigarette prevention intervention that uses virtual reality (VR) to deliver prevention and emotion regulation skills-building content to middle school students in real-world classrooms. If successful, E-invite Only VR has the potential to prevent adolescents from experiencing a multitude of poor health outcomes related to nicotine vaping, including cancer.

Study Overview

• Status: Not yet recruiting
• Conditions: Adolescent Mental Health; E-cigarette Use/Vaping Prevention; Nicotine Dependence Prevention
• Intervention / Treatment: Behavioral: Virtual Reality E-Cigarette Prevention Program

Detailed Description

After the 12-month follow-up period, schools in the control arm will receive access to the E-Invite Only VR intervention, allowing students and staff to utilize the program as part of their regular health education curriculum.

The clinical trial portion of this study will be informed by preliminary focus groups and surveys.

• Study Type: Interventional
• Enrollment (Estimated): 1251
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kimberly Hieftje D Associate Professor of Pediatrics, PhD; Phone Number: 12037375595; Email: kimberly.hieftje@yale.edu
• Study Contact Backup: Name: Deepa Camenga Associate Professor of Emergency Medicine, MD; Email: deepa.camenga@yale.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale School of Medicine
      • Contact: Kimberly Hieftje Associate Professor of Pediatrics, PhD; Phone Number: 203-737-5595; Email: kimberly.hieftje@yale.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria

• Enrolled in the 8th grade in one of the 20 partner middle schools (8 in Connecticut, 12 in Massachusetts).
• Willing to participate in a VR videogame for approximately 45 minutes per session, accumulating 2-2.5 hours of total gameplay across multiple class periods.
• Able to provide assent and obtain parental/guardian consent before participating in the study.

Exclusion Criteria

• Students not enrolled in 8th grade at one of the participating schools.
• Students who are unwilling or unable to participate in VR gameplay for the required duration.
• Students who cannot provide assent or do not have parental/guardian consent to participate .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: E-Invite Only VR: A Virtual Reality E-Cigarette Prevention Intervention; Participants in this arm will receive the E-Invite Only VR intervention, a school-based, virtual reality (VR) e-cigarette prevention program designed for 8th-grade students. The intervention leverages immersive VR technology and interactive gameplay to educate students about the risks of e-cigarette use, develop their refusal skills, and promote mental health awareness. Students will engage in role-playing scenarios where they practice resisting peer pressure and making informed decisions about vaping. The intervention integrates social and emotional learning (SEL) principles, focusing on emotional regulation and healthy coping strategies to reduce the likelihood of e-cigarette initiation. The VR-based intervention will be delivered over multiple class sessions, totaling approximately 2-2.5 hours of gameplay. Trained school staff and research personnel will oversee implementation during school hours.	Behavioral: Virtual Reality E-Cigarette Prevention Program; The E-Invite Only VR intervention is a school-based, virtual reality (VR) e-cigarette prevention program designed for 8th-grade students. It is an enhanced version of the Invite Only VR game, incorporating mental health promotion content alongside e-cigarette prevention education. The intervention leverages interactive gameplay to build emotion regulation skills and increase students' ability to resist peer pressure to use e-cigarettes. It aligns with behavior change theories, including the Theory of Planned Behavior and Social Cognitive Theory, to improve knowledge, harm perceptions, and self-efficacy related to vaping prevention; Other Names: E-Invite Only
No Intervention: Wait-list Control (Standard Health Curriculum); Participants in this arm will receive the standard e-cigarette prevention education currently provided by their school as part of the existing health curriculum. Unlike the intervention arm, students in the control group will not have access to the E-Invite Only VR program during the study period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants E-cigarette Initiation	E-cigarette use is defined as answering "yes" to the question: "Have you ever used an e-cigarette, even once or twice?" Participants will be classified as having initiated e-cigarette use if they report any past use at any of these time points.	3, 6, and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
E-Cigarette Knowledge	Measures changes in students' knowledge of e-cigarettes, including nicotine addiction, marketing tactics, laws, and regulations. Items are summed to create a total knowledge score ranging from 0 to 15, with higher scores indicating greater knowledge	Baseline, 3, 6, and 12 months post-intervention
E-Cigarette Harm Perceptions	All harm perception items use a 5-point scale coded from 1 (not at all harmful) to 5 (extremely harmful). The addiction likelihood items use a parallel 5-point scale coded from 1 (not at all likely) to 5 (extremely likely). Items may be examined individually or combined into composite scores with separate subscales for harm perceptions (Items 1, 2, 3, and 5) and addiction likelihood (Items 4 and 6). Higher scores indicate stronger perceptions of harm or addiction risk.	Baseline, 3, 6, and 12 months post-intervention
E-Cigarette Social Perceptions	The first two items use a 4-point Likert scale coded from 1 (strongly/completely disagree) to 4 (strongly/completely agree). The perceived peer acceptability item is coded from 1 (not acceptable) to 4 (completely acceptable). The peer influence item is coded from 1 (friends would tell you not to take a hit) to 4 (friends would exclude you for not taking a hit), with higher scores indicating stronger perceived social pressure to vape. The social media exposure item is coded from 1 (content posted by Public Health Campaigns) to 5 (content posted by e-cigarette brands or sellers), with higher scores reflecting greater exposure to promotional sources rather than educational sources and close peers. Items may be analyzed individually or summed to create a composite index of social norms and perceived social influences related to e-cigarette use, with higher scores indicating more permissive or pro-vaping social perceptions.	Baseline, 3, 6, and 12 months post-intervention
Healthy Attitudes Toward E-Cigarette Use	Participants will complete a pre-survey through a secured, data collection website (Qualtrics Data Collection Software) and then play the videogame intervention. The survey includes 4 questions adapted from the National Youth Tobacco Survey (2014) focus on attitudes about e-cigarettes. Questions have 4 response choices ranging from 1 (strongly disagree) to 4 (strongly agree) or 1 (definitely yes) to 4 (definitely not), or 1 (very unlikely) to 4 (very likely). Some items were reverse coded so that scores of 1 always represented less healthy attitudes and scores of 4 corresponded to more healthy attitudes. Items were averaged into a composite scale that ranged from 1 to 4, with higher scores indicating healthier attitudes.	Baseline, 3, 6, and 12 months post-intervention
Self-Efficacy for E-Cigarette Refusal	Assesses students' confidence in resisting peer pressure to use e-cigarettes. Responses are scored on a 4-point scale ranging from 1 (Not at all sure) to 4 (Very sure). Each item reflects a distinct situation in which students may encounter opportunities or pressure to vape. Scores are summed across the eight items to create a total refusal self-efficacy score, with higher scores indicating greater confidence in the ability to refuse an e-cigarette across a range of social and emotional contexts.	Baseline, 3, 6, and 12 months post-intervention
Difficulties in Emotion Regulation Scale - Short Form (DERS-16)	Measures students' confidence in implementing mental health promotion skills, including accessing support services. Total scores range from 16 to 80. Higher scores indicate greater difficulties with emotion regulation across domains such as nonacceptance, goal-directed behavior, impulse control, awareness, clarity, and access to regulation strategies	Baseline, 3, 6, and 12 months post-intervention
Coping Skills- Brief COPE Inventory	Evaluates the extent to which students apply adaptive coping strategies and emotion regulation skills in response to stress and social pressures. The reduced item set includes one item from each of the following Brief COPE subscales: self-distraction, active coping, denial, substance use, positive reframing, emotional support, religion, acceptance, venting, planning, and humor. Subscale scores range from 1 to 4, with higher scores indicating more frequent use of that coping strategy.	Baseline, 3, 6, and 12 months post-intervention
Intention to Use E-Cigarettes- Pierce Susceptibility Measure	Measures students' susceptibility to future e-cigarette use using a validated measure assessing intention and curiosity about vaping. Total scores range from 3 to 12. Higher scores indicate greater intention or openness to future e-cigarette use.	Baseline, 3, 6, and 12 months post-intervention

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Kimberly Hieftje D Associate Professor of Pediatrics, PhD, Yale University; Principal Investigator: Deepa Camenga Associate Professor of Emergency Medicine, MD, Yale University

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: March 3, 2026
• First Submitted That Met QC Criteria: March 3, 2026
• First Posted (Actual): March 10, 2026

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: emotion regulation skills; Digital health intervention; E-cigarette prevention; Vaping prevention; Nicotine addiction prevention; Virtual reality intervention; School-based prevention program; Mental health and substance use
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Behavior; Personal Satisfaction; Substance-Related Disorders; Psychological Well-Being
• Other Study ID Numbers: 2000039342_a; 1R01CA294027-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified study data will be archived and shared through Dryad, an open-source research data repository available to Yale-affiliated researchers. The study data will be stored securely in RedCap, with only unique study identification numbers used-no personal identifying information will be included. At the end of the study, all databases will be de-identified and archived in accordance with institutional and funding agency requirements
• IPD Sharing Time Frame: The Individual Participant Data (IPD) will be available following the conclusion of the study and after primary results are published. Data will remain available for a period of at least five years following the final study publication.
• IPD Sharing Access Criteria: De-identified data will be stored in Dryad, an open-access data repository available to Yale-affiliated researchers. Researchers can request access through a formal data-sharing agreement with the principal investigators. Data will be managed through RedCap, ensuring security and compliance with IRB and HIPAA regulations.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No