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E-cigarette Use/Vaping PreventionNCT07460622

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

A study testing Virtual Reality E-Cigarette Prevention Program in people with E-cigarette Use/Vaping Prevention and Nicotine Dependence Prevention, run by Yale University at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 11 to 15 yearsHealthy volunteers can take part
What is being tested?
Virtual Reality E-Cigarette Prevention Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,251 participants
Where
1 siteUnited States
Study dates
1 Oct 2026to Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 11 to 15 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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 .

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

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

United States1 site
  • Yale School of Medicine

    New Haven, Connecticut, 06510

    Kimberly Hieftje Associate Professor of Pediatrics, PhD, 203-737-5595, kimberly.hieftje@yale.edu

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Virtual Reality E-Cigarette Prevention Program
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
Medical subject headings
Psychological Well-Being, Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual Reality E-Cigarette Prevention ProgramBehavioural

    Also called E-Invite Only

    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

Study groups in NCT07460622
Study groupRoleWhat they receive
E-Invite Only VR: A Virtual Reality E-Cigarette Prevention InterventionExperimentalParticipants 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.
Receives: Behavioral: Virtual Reality E-Cigarette Prevention Program
Wait-list Control (Standard Health Curriculum)No interventionParticipants 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 being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3, 6, and 12 months

Secondary outcomes (8)
  1. 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

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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

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

  7. 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.

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

  8. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2026
  2. Study start1 Oct 2026 (estimated)
  3. Primary completionJun 2028 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,251 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07460622
Sponsor's protocol ID
2000039342_a
Other IDs
1R01CA294027-01A1
Status last verified
Mar 2026
First submitted
3 Mar 2026
Last updated
10 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Reality E-Cigarette Prevention Program in people with E-cigarette Use/Vaping Prevention and Nicotine Dependence Prevention, run by Yale University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kimberly Hieftje D Associate Professor of Pediatrics, PhD (12037375595, kimberly.hieftje@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants E-cigarette Initiation (time frame: 3, 6, and 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.

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