- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00682474
School Nurse-Delivered Smoking Cessation Intervention
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Smoking is the largest preventable cause of disease and premature death in the United States. Adolescent smoking is the greatest predictor of adult smoking and is associated with adverse health effects during adolescence. Twenty-two percent of high school students report current smoking (past 30 days). As the primary health professional in the school setting, school nurses have a tremendous opportunity to play a key role in treating adolescent smokers. A randomized controlled trial (RCT) conducted by the investigators in 71 high schools in Massachusetts demonstrated the feasibility of school nurses delivering a four-session individual counseling intervention to adolescents who want to stop smoking and its potential efficacy in increasing self-reported short term (6-week and 3-month) quit rates. Although promising, the preliminary study lacked biochemical validation and long-term follow-up on the maintenance of the intervention effects, and was conducted with a primarily white student population. This application seeks to evaluate the effectiveness of the intervention using a more rigorous methodology, including biochemical validation of self-reported smoking behavior and longer-term follow-up (6 and 12 months post-intervention), a study design that compares the intervention to an information only attention-control condition, and recruitment from ethnically diverse schools to increase the generalizability of our findings.
The overall aim of the proposed study is to conduct a randomized controlled school-based trial (RCT) to evaluate the effectiveness of a school nurse-delivered smoking cessation intervention in increasing 30 day abstinence rates among high school students who smoke. Forty high schools serving a diverse student population will be recruited and randomly assigned to one of two conditions: (1) Special Intervention (SI) - four 30-minute individual patient-centered smoking cessation counseling intervention sessions based on the Public Health Service (PHS) clinical practice guideline delivered by school nurses; or (2) Information Only (IO) attention-control comparison condition - four individual sessions with the school nurse to check smoking status and deliver a standardized series of informational pamphlets on smoking and cessation. Participant assessments will occur at study entry (baseline) and at 3-,12-month follow-up. Thirty students enrolled in grades 9 through 12 who report smoking within the past 30 days and willingness to participate in a smoking cessation intervention study will be recruited from each school (n=1200) to provide 25 completed assessments per school at 12-month follow-up (n=1000). If found effective, the study products (i.e., intervention protocol, student materials, training manual, and estimated costs of intervention implementation) will facilitate dissemination of the intervention to school nurses nationally.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
- Fase 3
Kontakter og lokationer
Studiesteder
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Massachusetts
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Worcester, Massachusetts, Forenede Stater, 01655
- University of Massachusetts Medical School
-
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- enrolled in grades 9-12
- report smoking at least one puff of a cigarette in the past 30 days
- willingness to participate in a smoking cessation intervention study
- able to speak and read English
- able to complete the baseline questionnaire independently, indicating ability to complete study assessments and protocols
- intending to remain enrolled in the school for the remainder of the school year
- willing to provide contact information for the next 12 months
Exclusion Criteria:
- unwilling/unable to provide informed assent
- planning to move out of the area in the next 6 months
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: CI
Four 30-minute individual student-centered smoking cessation counseling intervention sessions delivered by school nurses to adolescent smokers in grades 9-12
|
Four 30-minute individual student-centered smoking cessation counseling intervention sessions delivered by school nurses to adolescent smokers in grades 9-12
Andre navne:
|
Aktiv komparator: II
Attention-control comparison condition consisting of four individual sessions with the school nurse to check smoking status and deliver a series of standardized pamphlets on smoking and cessation to adolescent smokers in grades 9-12
|
Attention-control comparison condition consisting of four individual sessions with the school nurse to check smoking status and deliver a series of standardized pamphlets on smoking and cessation to adolescent smokers in grades 9-12
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Abstinence from cigarette smoking in the past 30 days at 3 months and 1 year.
Tidsramme: 3 months and 1 year post baseline
|
3 months and 1 year post baseline
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Reduction in number of cigarettes and days smoked
Tidsramme: 3 months and 1 year post baseline
|
3 months and 1 year post baseline
|
Samarbejdspartnere og efterforskere
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- R01CA114556 (U.S. NIH-bevilling/kontrakt)
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