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NCT Number: NCT07460622

A Virtual Reality E-cigarette Prevention and Emotion Regulation 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.

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Key information

Age range

11 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale School of Medicine

New Haven, Connecticut, 06510, United States

Location contact

Kimberly Hieftje Associate Professor of Pediatrics, PhD

CONTACT

[email protected]

203-737-5595

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

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

Other names: E-Invite Only

Primary outcomes

  1. Number of participants E-cigarette Initiation

    Time frame: 3, 6, and 12 months

    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.

Secondary outcomes

  1. E-Cigarette Knowledge

    Time frame: Baseline, 3, 6, and 12 months post-intervention

    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

  2. E-Cigarette Harm Perceptions

    Time frame: Baseline, 3, 6, and 12 months post-intervention

    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.

  3. E-Cigarette Social Perceptions

    Time frame: Baseline, 3, 6, and 12 months post-intervention

    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.

  4. Healthy Attitudes Toward E-Cigarette Use

    Time frame: Baseline, 3, 6, and 12 months post-intervention

    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.

  5. Self-Efficacy for E-Cigarette Refusal

    Time frame: Baseline, 3, 6, and 12 months post-intervention

    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.

  6. Difficulties in Emotion Regulation Scale - Short Form (DERS-16)

    Time frame: Baseline, 3, 6, and 12 months post-intervention

    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

  7. Coping Skills- Brief COPE Inventory

    Time frame: Baseline, 3, 6, and 12 months post-intervention

    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.

  8. Intention to Use E-Cigarettes- Pierce Susceptibility Measure

    Time frame: Baseline, 3, 6, and 12 months post-intervention

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Deepa Camenga Associate Professor of Emergency Medicine, MD

CONTACT

[email protected]

Kimberly Hieftje D Associate Professor of Pediatrics, PhD

CONTACT

[email protected]

12037375595

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 10, 2026
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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