- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07737080
The Villainous Vape: Advancing Vaping Prevention Among Adolescents Through a Comic Book
27. juli 2026 opdateret af: Francisco Cartujano, MD, University of Rochester
This is a randomized controlled trial to assess the feasibility, acceptability, and preliminary impact of The Villainous Vape, a vaping prevention comic book, among adolescents.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
90
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Francisco Cartujano, MD
- Telefonnummer: (585) 273-1646
- E-mail: francisco_cartujano@urmc.rochester.edu
Studiesteder
-
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New York
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Rochester, New York, Forenede Stater, 14642
- University of Rochester Medical Center
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Kontakt:
- Francisco Cartujano, MD
- Telefonnummer: 585-353-0035
- E-mail: francisco_cartujano@urmc.rochester.edu
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde frivillige
Ja
Beskrivelse
Inclusion Criteria:
- Know how to read and speak English and/or Spanish
- Be at least 12 but no greater than 17 years old
- Be willing to complete three study visits over Zoom or a phone call
- Live in Orleans County, New York
Exclusion Criteria:
- A household member participating in the study
- Living outside of Orleans County, New York
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: Health Impacts of E-cigarettes
|
Health Impacts of E-cigarettes is a one-page educational flyer that outlines the impact of using electronic cigarettes and what is being done to mitigate youth vaping.
The flyer reviews the dangers of nicotine delivery devices, lung damage, and how to stay safe in the event of social exposure to vaping.
Health Impacts of E-cigarettes was developed by the U.S. Food and Drug Administration.
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Aktiv komparator: Mind Matters: The Body's Response to Nicotine, Tobacco, and Vaping
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Mind Matters: The Body's Response to Nicotine, Tobacco, and Vaping is a five-page educational brochure that utilizes an illustrative approach to sharing basic information about nicotine and tobacco products.
The brochure focuses on the physiological effect of these products, health effects, addiction, and key statistics.
Mind Matters: The Body's Response to Nicotine, Tobacco, and Vaping was developed by the U.S. National Institute on Drug Abuse.
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Eksperimentel: The Villainous Vape
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The Villainous Vape is an eleven-page comic book that follows Daniel, a high school student who gets addicted to vaping and is hospitalized in the intensive care unit because he develops a lung disease.
Support from friends and family helps Daniel make the decision to quit vaping.
Throughout the comic, readers are exposed to various vaping-related facts and statistics.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage Of Participants Who Complete the Month 3 Assessment.
Tidsramme: Month 3
|
The percentage will be calculated as the number of participants who complete the Month 3 assessment divided by the total number of enrolled participants.
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Month 3
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Percentage Of Participants Who Are Satisfied With Their Assigned Intervention at Month 3
Tidsramme: Month 3
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All participants will be asked the following question at Month 3: "How satisfied are you with the assigned intervention?"
Responses will be collected using a 5-item Likert scale.
The percentage of participants who are satisfied with their assigned intervention at Month 3 will be calculated as the number of participants who respond "satisfied" or "extremely satisfied," divided by the total number of participants in each group.
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Month 3
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Percentage Of Participants With Reduced Susceptibility To Future Vaping
Tidsramme: Baseline to Month 3
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Susceptibility to future vaping will be assessed using the susceptibility to e-cigarettes scale.
The scale consists of three questions: 1) Have you ever been curious about using e-cigarettes?
2) Do you think you will use e-cigarettes in the next year?
3) If one of your best friends were to offer you an e-cigarette, would you use it?
The questions use a 4-point Likert scale ranging from not at all curious (1) to very curious (4) for question one and definitely not (1) to definitely yes (4) for questions two and three.
Participants who provide a response other than "not all curious" or "definitely not" will be considered "susceptible".
The percentage will be calculated as the number of participants who demonstrate a change from "susceptible" at baseline to "not susceptible" at Month 3, divided by the total number of participants in each group.
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Baseline to Month 3
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. september 2026
Primær færdiggørelse (Anslået)
31. marts 2027
Studieafslutning (Anslået)
31. marts 2027
Datoer for studieregistrering
Først indsendt
27. juli 2026
Først indsendt, der opfyldte QC-kriterier
27. juli 2026
Først opslået (Faktiske)
30. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
30. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
27. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- STUDY00011905
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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