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Lo studio clinico NCT07460622 per E-cigarette Use/Vaping Prevention, Nicotine Dependence Prevention, Adolescent Mental Health è non ancora in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
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A Virtual Reality E-cigarette Prevention and Emotion Regulation Intervention for Adolescents 1.251 Dati real-world Adolescenti Innovativo Prevenzione
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La sperimentazione clinica NCT07460622 è uno studio interventistico per E-cigarette Use/Vaping Prevention, Nicotine Dependence Prevention, Adolescent Mental Health, attualmente non ancora in arruolamento. L'arruolamento dovrebbe iniziare il 1 ottobre 2026, con l'obiettivo di raggiungere 1.251 partecipanti. Sotto la guida di l'Università di Yale, dovrebbe concludersi entro il 1 giugno 2028. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 10 marzo 2026.
Sommario breve
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, incl...Mostra di più
Descrizione dettagliata
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.
Titolo ufficiale
E-cigarette Prevention and Emotion Regulation: Virtual Reality Intervention for Adolescents
Patologie
E-cigarette Use/Vaping PreventionNicotine Dependence PreventionAdolescent Mental HealthAltri ID dello studio
Numero NCT
Data di inizio (effettiva)
2026-10-01
Ultimo aggiornamento pubblicato
2026-03-10
Data di completamento (stimata)
2028-06
Arruolamento (previsto)
1.251
Tipo di studio
Interventistico
FASE
N.D.
Stato
Non ancora in arruolamento
Parole chiave
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
Vaping prevention
Nicotine addiction prevention
Virtual reality intervention
School-based prevention program
Mental health and substance use
Digital health intervention
emotion regulation skills
Scopo principale
Prevenzione
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Nessuno (studio in aperto)
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
SperimentaleE-Invite Only VR: A Virtual Reality E-Cigarette Prevention Intervention 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...Mostra di più | 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 ...Mostra di più |
Nessun interventoWait-list Control (Standard Health Curriculum) 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. | N.D. |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
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. | 3, 6, and 12 months |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
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 | 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. | 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. | 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. | 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. | 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 | 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. | 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. | Baseline, 3, 6, and 12 months post-intervention |
Assistente alla partecipazione
Criteri di eleggibilità
Età idonea
Bambino
Età minima
11 Years
Sessi idonei
Tutti
Accetta volontari sani
Sì
- 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.
- 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 .
Contatti principali dello studio
Contatto: Kimberly Hieftje D Associate Professor of Pediatrics, PhD, 12037375595, [email protected]
Contatto: Deepa Camenga Associate Professor of Emergency Medicine, MD, [email protected]
1 Centri dello studio in 1 paesi
Connecticut
Yale School of Medicine, New Haven, Connecticut, 06510, United States
Kimberly Hieftje Associate Professor of Pediatrics, PhD, Contatto, 203-737-5595, [email protected]