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Not yet recruiting NCT07460622

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

No phase Interventional E-cigarette Use/Vaping Prevention Nicotine Dependence Prevention Adolescent Mental Health

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Virtual Reality E-Cigarette Prevention Program.
Who it may be relevant to
Registry conditions: E-cigarette Use/Vaping Prevention, Nicotine Dependence Prevention, Adolescent Mental Health. Basic parameters: 11 years — 15 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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 Theo

Primary outcome measures

  • Number of participants E-cigarette Initiation [Time frame: 3, 6, and 12 months]
Secondary outcome measures (8)
  • 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]

Eligibility criteria

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 .

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • Yale School of Medicine — New Haven

Identifiers

NCT: NCT07460622 · 2000039342_a · 1R01CA294027-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗