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

NCT07460622 | Not Yet Recruiting DMC

• 2 other identifiers: 2000039342_a1R01CA294027-01A1
• Study Type: interventional
• Target: 1,251
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

E-cigarette Use/Vaping Prevention; Nicotine Dependence Prevention; Adolescent Mental Health

Keywords

E-cigarette prevention; Vaping prevention; Nicotine addiction prevention; Virtual reality intervention; School-based prevention program; Mental health and substance use; Digital health intervention; emotion regulation skills

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• E-Cigarette Knowledge

  Baseline, 3, 6, and 12 months post-intervention

• E-Cigarette Harm Perceptions

  Baseline, 3, 6, and 12 months post-intervention

• E-Cigarette Social Perceptions

  Baseline, 3, 6, and 12 months post-intervention

• Healthy Attitudes Toward E-Cigarette Use

  Baseline, 3, 6, and 12 months post-intervention

• Self-Efficacy for E-Cigarette Refusal

  Baseline, 3, 6, and 12 months post-intervention

Study Arms (2)

E-Invite Only VR: A Virtual Reality E-Cigarette Prevention Intervention

EXPERIMENTAL

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

Wait-list Control (Standard Health Curriculum)

NO INTERVENTION

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.

Interventions

Virtual Reality E-Cigarette Prevention Program BEHAVIORAL

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

Also known as: E-Invite Only

E-Invite Only VR: A Virtual Reality E-Cigarette Prevention Intervention

Eligibility Criteria

• Age: 11 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Yale University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Yale School of Medicine

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Psychological Well-Being; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Kimberly Hieftje D Associate Professor of Pediatrics, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

• Deepa Camenga Associate Professor of Emergency Medicine, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kimberly Hieftje D Associate Professor of Pediatrics, PhD

CONTACT

12037375595; kimberly.hieftje@yale.edu

Deepa Camenga Associate Professor of Emergency Medicine, MD

CONTACT

deepa.camenga@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2026
• First Posted: March 10, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.
• 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.

Locations

US (1)