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Набор по приглашению NCT07362069

A Virtual Reality Vaping Prevention Intervention for Adolescents

Наблюдательное Vaping

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Vaping. Базовые параметры: 12 лет — 15 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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. In Phase 1, investigators will conduct focus groups with adolescents and interviews with school staff to inform the development and implementation of the intervention.

Подробное описание

Investigators will conduct focus groups with adolescents. 4 focus groups will focus on collecting adolescents' perceptions about e-cigarettes and students' mental health needs in general, and how they perceive the link between the 2 constructs. Participants will also play E-Invite Only VR and then convene to share their thoughts and experiences. Participants will also fill out surveys including the System Usability Scale and the Gameplay Experience Questionnaire.

Staff will review and discuss the E-Invite Only VR implementation plan and respond to the Feasibility of Implementation Plan assessment during the interviews. Investigators will work with two populations: 1) Adolescents attending 8th grade in one of our partner schools, and 2) School staff employed by a partner school.

The target user for the E-Invite Only VR intervention is 8th grade students because the game is focused on prevention. Early adolescence is known to be a critical period for the risk of nicotine dependence and the transition between middle school and high school is a period when youth might be particularly likely to experiment with substances such as e-cigarettes.

Investigators will work with school staff to ensure the E-Invite Only VR intervention is feasible to implement in schools.

Первичные конечные точки

  • Acceptability of the the Videogame [Срок оценки: Immediately after the focus group and gameplay testing of the intervention, Day 1]
  • System Usability Scale [Срок оценки: Immediately after the focus group and gameplay, Day 1]
  • Feasibility of Implementation [Срок оценки: Immediately after interviews with school staff, Day 1]

Критерии участия

School staff:

  • employed by one of our partner schools
  • could use the enhanced intervention with students OR work directly with students at risk for e-cigarette use/mental health concerns
  • age greater than or equal to 18 years
  • English speaking

8th grade adolescents

  • enrolled in 8th grade in one of our partner schools
  • willing to engage in discussions about their experiences and perceptions related to e-cigarettes and mental health promotion
  • English speaking

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

США · 2 центра
  • Yale University — New Haven
  • Massachusetts General Hospital — Boston

Идентификаторы

NCT: NCT07362069 · 2000039342 · 1R01CA294027

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗