An Online Intervention to Reduce E-cigarette Use and Cigarette Smoking Risk in Adolescents
31. května 2026 aktualizováno: Denise Tran, University of Southern California
An Online Intervention to Reduce E-cigarette Use and Potential for Cigarette Smoking in Adolescents
The goal of this clinical trial is to learn if a brief digital intervention can reduce e-cigarette use and prevent cigarette smoking initiation in teenagers ages 12-17. The main questions it aims to answer are:
- Compared to the control condition, does the intervention reduce e-cigarette use frequency in teenagers?
- Compared to the control condition, does the intervention reduce risk to start smoking cigarettes in teenagers? Researchers will compare the digital intervention to see if it leads to greater reductions in e-cigarette use and smoking risk than a waitlist control condition.
Participants will complete 5 brief online surveys across 12 weeks, and some will be selected to do a post-intervention virtual interview. In this interview, participants will be asked to share their opinions about the intervention and identify areas that need refinement.
Přehled studie
Postavení
Zatím nenabíráme
Podmínky
Intervence / Léčba
Typ studie
Intervenční
Zápis (Odhadovaný)
150
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Denise Tran, Ph.D.
- Telefonní číslo: 17145487785
- E-mail: denise.tran@med.usc.edu
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
Přijímá zdravé dobrovolníky
Ne
Popis
Inclusion Criteria:
- be between the ages of 12 to 17
- be able to read English
- be a current resident of California
- report vaping at least one day per week in the past month
- report no history of cigarette use at screening and baseline
- have access to a computer or mobile device with internet access
Exclusion Criteria:
- currently receiving nicotine cessation services
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Digital vaping intervention
Virtual Intervention for Behavioral Empowerment (VIBE) is a one-time 30-minute online intervention that incorporates Personalized Normative Feedback (PNF) for vaping and smoking, motivational enhancement to encourage healthy behavior change, and vaping and smoking-related harms education.
Lastly, strategies recommended for nicotine cessation are presented.
This intervention can be completed in one sitting or split into multiple sessions and is delivered via an interactive website.
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The intervention contains Personalized Normative Feedback (PNF), motivational interviewing (MI), and education about vaping and smoking harms.
The program begins with the MI-based portion, which includes exploration of their experienced health and personal consequences of vaping and potential reasons for and motivation for shifting vaping behaviors (e.g., to save money, to be free from addiction).
Second, the education portion involves presentation of the actual harms posed by e-cigarettes to clarify any misperceptions of the negative effects of vaping and nicotine exposure in teens.
Next, users are presented with the PNF portion.
In the PNF portion, participants receive feedback about their perceptions of peer vaping by presenting their typical behavior/attitude alongside their perceptions of others' behavior/attitude alongside the actual norm of the behavior/attitude.
Lastly, strategies recommended for nicotine cessation are presented.
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Žádný zásah: Waitlist control
Those in the control arm will be waitlisted and given the option to access VIBE (the intervention) at the end of study.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Days vaped in the past 7 days
Časové okno: Past 7 day vaping measured at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks post-randomization.
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Participants will report the number of days they vaped in the past 7 days.
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Past 7 day vaping measured at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks post-randomization.
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Times vape is picked up per day
Časové okno: Past 7 day vaping measured at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks post-randomization.
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Participants will report the number of times they picked up their device to vape per day in the past 7 days.
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Past 7 day vaping measured at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks post-randomization.
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Smoking Susceptibility
Časové okno: Past 7 day smoking susceptibility measured at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks post-randomization.
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Smoking susceptibility will be assessed with the 4-item Expanded Susceptibility to Smoking Index, with the following responses: Definitely not, Probably not, Probably yes, and Definitely yes.
This is a binary outcome.
If a respondent answers "definitely not" to all four questions, they are categorized as not susceptible.
Any other response on any item flags the respondent as susceptible.
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Past 7 day smoking susceptibility measured at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks post-randomization.
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Vaping Quit Attempts
Časové okno: Vaping quit attempts in the past 7 days assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
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Quit attempts will be measured with questions asking for the number of quit attempts lasting at least 1 day since the last assessment.
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Vaping quit attempts in the past 7 days assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
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Vaping Descriptive Normative Perceptions
Časové okno: Vaping normative perceptions assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
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Participants will report their beliefs regarding the percentage of teens who vaped, number of days individuals their age vaped, the number of times others their age picked up their vaping device per day in the past 30 days,
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Vaping normative perceptions assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
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Vaping Injunctive Normative Perceptions
Časové okno: Vaping normative perceptions assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
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Participants will report how much they believe others their age approve (or disapprove) of vaping using a 5-point Likert scale (responses options: Strongly disapprove to Strongly approve).
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Vaping normative perceptions assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
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Smoking Descriptive Normative Perceptions
Časové okno: Smoking normative perceptions assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
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Participants will report their beliefs about the percentage of teens who have smoked, the number of days others their age smoked in the past 30 days, and the quantity of cigarettes others their age smoked per day in the past 30 days.
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Smoking normative perceptions assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
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Smoking Injunctive Normative Perceptions
Časové okno: Smoking normative perceptions assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
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Participants will report how much they believe others their age approve (or disapprove) of cigarette smoking using a 5-point Likert scale (responses options: Strongly disapprove to Strongly approve).
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Smoking normative perceptions assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
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Quitting vaping self-efficacy
Časové okno: Self-efficacy in the past 7 days assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
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Self-efficacy will be assessed by 2 adapted items that originally assessed self-efficacy to quit smoking.
Participants rate their confidence about quitting vaping "someday" and "in the next 6 months."
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Self-efficacy in the past 7 days assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
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Motivation to Quit Vaping
Časové okno: Motivation to quit in the past 7 days assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
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Motivation will be assessed by asking participants whether they were seriously thinking about quitting vaping with responses ranging from 1 = No, I am not thinking about quitting to 5 = Yes, I want to quit during the next 30 days.
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Motivation to quit in the past 7 days assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Spolupracovníci
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
1. července 2026
Primární dokončení (Odhadovaný)
30. března 2027
Dokončení studie (Odhadovaný)
30. března 2027
Termíny zápisu do studia
První předloženo
21. května 2026
První předloženo, které splnilo kritéria kontroly kvality
31. května 2026
První zveřejněno (Aktuální)
3. června 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
3. června 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
31. května 2026
Naposledy ověřeno
1. května 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- T35IP9813
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
ANO
Popis plánu IPD
Individual participant data that underlie the results reported in this study, after de-identification, will be shared.
The Study Protocol and Statistical Analysis Plan will also be available.
Data will be available beginning 9 months and ending 36 months following article publication to researchers who provide a methodologically sound proposal to achieve the aims in the approved proposal.
Proposals must be approved by the Principal Investigator.
Please submit requests and usage plans to deniset@usc.edu.
Časový rámec sdílení IPD
Data will be available beginning 9 months and ending 36 months following article publication upon approval.
Kritéria přístupu pro sdílení IPD
De-identified individual participant data will be shared with external researchers who submit a scientifically meritorious research proposal and a comprehensive Statistical Analysis Plan (SAP).
Data may be utilized for any secondary analysis or meta-analysis that contributes to public health knowledge.
Requests will be evaluated directly by the Principal Investigator.
Access is conditional upon the signing of a standard institutional Data Sharing Agreement.
Data files will be securely shared via email attachment or secure cloud download.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- ANALYTIC_CODE
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .