- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05396911
Development of UP2UTeacher for High School Youth (UP2UTeacher)
Pilot Testing an Anti-Tobacco Intervention to Reduce Tobacco and Nicotine Use Among High School Students and Determine Feasibility
Tobacco use is increasing among youth in the U.S. However evidence for the long-term effectiveness of tobacco prevention and cessation programs for youth is limited. The current study seeks to adapt and evaluate a universal group-based youth brief tobacco intervention for 9th grade students.
This study will use a sequential, multi-method research design beginning with qualitative roundtable discussions with 9th grade students to adapt an existing young adult brief tobacco intervention for youth. Roundtable discussions with students will identify salient intervention themes and strategies for targeting the intervention and developing the text messages. The second phase of the study evaluates the brief intervention, UP2UTeacher, through a cluster randomized controlled trial that compares UP2UTeacher to a no treatment control. It is hypothesized that the UP2UTeacher will reduce tobacco use at the 12-month follow-up compared to the no treatment control.
Roughly 90% of daily smokers started before the age of 18, and 2,000 youth smoke a cigarette for the first time each day in the U.S. Additionally, e-cigarette use is on the rise among youth, and is linked to cigarette initiation among tobacco naïve youth. In order to curb the rise of tobacco use among youth, interventions that are easily implemented and easily disseminated need to be developed for youth addressing currently available products and contemporary patterns of use. If the interventions in the current study are proven efficacious, they can easily be disseminated to other schools to continue reducing youth tobacco use.
Studieoversigt
Status
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Virginia
-
Charlottesville, Virginia, Forenede Stater, 22904
- University of Virginia
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Enrolled in the selected physical education or health class selected for participation in the study.
Exclusion Criteria:
- None
Studieplan
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 |
|---|---|
|
Ingen indgriben: Ingen behandlingskontrol
|
|
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Eksperimentel: UP2UTeacher
Youth Brief Tobacco Intervention |
The universal prevention program was designed as a group intervention to include components of effective tobacco control programs for youth and young adults. The intervention lasts approximately 45 minutes and is delivered in a classroom setting, utilizing a Socratic teaching style and evoking participation using the principles of motivational interviewing. UP2UTeacher targets all tobacco products with the goals to enhance motivation for youth to quit tobacco or remain tobacco-free, reduce intentions to use tobacco, promote peer discussions around the impact of using tobacco, and correct cognitive misperceptions around tobacco use.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Past 30-day Tobacco Use
Tidsramme: past 12 months
|
The primary outcome measure in this study is self-reported past 30-day use of cigarettes, e-cigarettes, smokeless tobacco, hookah, cigars, little cigars, cigarillos, pipe tobacco, nicotine pouches and dissolvables. Past 30-day use will be determined for each product by asking participants, "In the past 30 days, did you use the following products?" with response options of "Every day" or "Some days" determining tobacco use. |
past 12 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Lifetime Tobacco Use
Tidsramme: past 12 months
|
The secondary outcome measure in this study is self-reported lifetime use of cigarettes, e-cigarettes, smokeless tobacco, hookah, cigars, little cigars, cigarillos, pipe tobacco, nicotine pouches and dissolvables. Lifetime use will be determined for each product by a "Yes" response to the question, "In your lifetime, have you ever tried the following products, even once or twice?" at the 12-month follow-up. |
past 12 months
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SBS4719
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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