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An Online Intervention to Reduce E-cigarette Use and Cigarette Smoking Risk in Adolescents

31 mei 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

150

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Ander: Virtual Intervention for Behavioral Empowerment (VIBE)
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.
Geen tussenkomst: Waitlist control
Those in the control arm will be waitlisted and given the option to access VIBE (the intervention) at the end of study.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Days vaped in the past 7 days
Tijdsspanne: Past 7 day vaping measured at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks post-randomization.
Participants will report the number of days they vaped in the past 7 days.
Past 7 day vaping measured at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks post-randomization.
Times vape is picked up per day
Tijdsspanne: Past 7 day vaping measured at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks post-randomization.
Participants will report the number of times they picked up their device to vape per day in the past 7 days.
Past 7 day vaping measured at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks post-randomization.
Smoking Susceptibility
Tijdsspanne: Past 7 day smoking susceptibility measured at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks post-randomization.
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.
Past 7 day smoking susceptibility measured at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks post-randomization.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Vaping Quit Attempts
Tijdsspanne: Vaping quit attempts in the past 7 days assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
Quit attempts will be measured with questions asking for the number of quit attempts lasting at least 1 day since the last assessment.
Vaping quit attempts in the past 7 days assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
Vaping Descriptive Normative Perceptions
Tijdsspanne: Vaping normative perceptions assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
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,
Vaping normative perceptions assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
Vaping Injunctive Normative Perceptions
Tijdsspanne: Vaping normative perceptions assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
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).
Vaping normative perceptions assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
Smoking Descriptive Normative Perceptions
Tijdsspanne: Smoking normative perceptions assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
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.
Smoking normative perceptions assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
Smoking Injunctive Normative Perceptions
Tijdsspanne: Smoking normative perceptions assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
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).
Smoking normative perceptions assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
Quitting vaping self-efficacy
Tijdsspanne: Self-efficacy in the past 7 days assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
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."
Self-efficacy in the past 7 days assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
Motivation to Quit Vaping
Tijdsspanne: Motivation to quit in the past 7 days assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
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.
Motivation to quit in the past 7 days assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Southern California

Medewerkers

Tobacco Related Disease Research Program

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juli 2026

Primaire voltooiing (Geschat)

30 maart 2027

Studie voltooiing (Geschat)

30 maart 2027

Studieregistratiedata

Eerst ingediend

21 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

31 mei 2026

Eerst geplaatst (Werkelijk)

3 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

3 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

31 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • T35IP9813

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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.

IPD-tijdsbestek voor delen

Data will be available beginning 9 months and ending 36 months following article publication upon approval.

IPD-toegangscriteria voor delen

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.

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ANALYTIC_CODE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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