School Nurse-Delivered Smoking Cessation Intervention
Condition: Cigarette Smoking; Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Counseling Intervention; Information Intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Four 30-minute individual student-centered smoking cessation counseling intervention sessions delivered by school nurses 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
Other intervention name(s): Calling It Quits
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Cigarette smoking; Nicotine dependence; Adolescents; Youth; School health; Randomized controlled trial