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.
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
- Conditions the study is for
- E-cigarette Use/Vaping Prevention, Nicotine Dependence Prevention, Adolescent Mental Health
- What is being tested?
- Virtual Reality E-Cigarette Prevention Program
- Type of treatment
- Lifestyle or therapy programme
- 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
Deepa Camenga Associate Professor of Emergency Medicine, MD contact
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
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.
- Conditions
- E-cigarette Use/Vaping Prevention, Nicotine Dependence Prevention, Adolescent Mental Health
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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
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
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
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
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.
- First posted10 Mar 2026
- Study start1 Oct 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for E-cigarette Use/Vaping PreventionStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Kimberly Hieftje D Associate Professor of Pediatrics, PhD, Principal investigator, Yale UniversityDeepa Camenga Associate Professor of Emergency Medicine, MD, Principal investigator, Yale University
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- E-cigarette Prevention and Emotion Regulation: Virtual Reality Intervention for Adolescents
- ClinicalTrials.gov ID
- NCT07460622
- Acronym / sponsor ID
- 2000039342_a
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,251 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| E-Invite Only VR: A Virtual Reality E-Cigarette Prevention Intervention | Experimental | Behavioral: Virtual Reality E-Cigarette Prevention ProgramParticipants 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. |
| 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. |
Who may qualify
- Ages
- 11 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality E-Cigarette Prevention ProgramAlso: E-Invite OnlyThe 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 | Behavioural | E-Invite Only VR: A Virtual Reality E-Cigarette Prevention Intervention |
Primary outcome
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.
8 secondary outcomes
E-Cigarette Knowledge
Time frame: Baseline, 3, 6, and 12 months post-intervention
E-Cigarette Harm Perceptions
Time frame: Baseline, 3, 6, and 12 months post-intervention
E-Cigarette Social Perceptions
Time frame: Baseline, 3, 6, and 12 months post-intervention
Healthy Attitudes Toward E-Cigarette Use
Time frame: Baseline, 3, 6, and 12 months post-intervention
Self-Efficacy for E-Cigarette Refusal
Time frame: Baseline, 3, 6, and 12 months post-intervention
Difficulties in Emotion Regulation Scale - Short Form (DERS-16)
Time frame: Baseline, 3, 6, and 12 months post-intervention
Coping Skills- Brief COPE Inventory
Time frame: Baseline, 3, 6, and 12 months post-intervention
Intention to Use E-Cigarettes- Pierce Susceptibility Measure
Time frame: Baseline, 3, 6, and 12 months post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kimberly Hieftje D Associate Professor of Pediatrics, PhD contact
Deepa Camenga Associate Professor of Emergency Medicine, MD contact
Kimberly Hieftje D Associate Professor of Pediatrics, PhD principal investigator
Yale University
Deepa Camenga Associate Professor of Emergency Medicine, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
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.