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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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

Первичные конечные точки

• Number of participants E-cigarette Initiation [Срок оценки: 3, 6, and 12 months]

Вторичные конечные точки (8)

• E-Cigarette Knowledge [Срок оценки: Baseline, 3, 6, and 12 months post-intervention]
• E-Cigarette Harm Perceptions [Срок оценки: Baseline, 3, 6, and 12 months post-intervention]
• E-Cigarette Social Perceptions [Срок оценки: Baseline, 3, 6, and 12 months post-intervention]
• Healthy Attitudes Toward E-Cigarette Use [Срок оценки: Baseline, 3, 6, and 12 months post-intervention]
• Self-Efficacy for E-Cigarette Refusal [Срок оценки: Baseline, 3, 6, and 12 months post-intervention]
• Difficulties in Emotion Regulation Scale - Short Form (DERS-16) [Срок оценки: Baseline, 3, 6, and 12 months post-intervention]
• Coping Skills- Brief COPE Inventory [Срок оценки: Baseline, 3, 6, and 12 months post-intervention]
• Intention to Use E-Cigarettes- Pierce Susceptibility Measure [Срок оценки: Baseline, 3, 6, and 12 months post-intervention]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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 .

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Yale School of Medicine — New Haven

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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