Nicotine Dependence Clinical Trial
Official title:
School Nurse-Delivered Smoking Cessation Intervention
The purpose of this study is to conduct a randomized controlled school-based trial to evaluate the effectiveness of a four-session school nurse-delivered smoking cessation intervention in increasing abstinence rates among high school students who smoke.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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