School Nurse-Delivered Smoking Cessation Intervention

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lori Pbert, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT00682474
First received: May 20, 2008
Last updated: August 18, 2011
Last verified: August 2011

May 20, 2008
August 18, 2011
September 2006
June 2009   (final data collection date for primary outcome measure)
Abstinence from cigarette smoking in the past 30 days at 3 months and 1 year. [ Time Frame: 3 months and 1 year post baseline ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00682474 on ClinicalTrials.gov Archive Site
Reduction in number of cigarettes and days smoked [ Time Frame: 3 months and 1 year post baseline ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
School Nurse-Delivered Smoking Cessation Intervention
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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Cigarette Smoking
  • Nicotine Dependence
  • Behavioral: Counseling Intervention
    Four 30-minute individual student-centered smoking cessation counseling intervention sessions delivered by school nurses to adolescent smokers in grades 9-12
    Other Name: Calling It Quits
  • Behavioral: Information Intervention
    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
  • Experimental: CI
    Four 30-minute individual student-centered smoking cessation counseling intervention sessions delivered by school nurses to adolescent smokers in grades 9-12
    Intervention: Behavioral: Counseling Intervention
  • Active Comparator: 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
    Intervention: Behavioral: Information Intervention
Pbert L, Druker S, DiFranza JR, Gorak D, Reed G, Magner R, Sheetz AH, Osganian S. Effectiveness of a school nurse-delivered smoking-cessation intervention for adolescents. Pediatrics. 2011 Nov;128(5):926-36. Epub 2011 Oct 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1058
February 2010
June 2009   (final data collection date for primary outcome measure)

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
Both
13 Years to 18 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00682474
R01CA114556
Yes
Lori Pbert, University of Massachusetts, Worcester
University of Massachusetts, Worcester
Not Provided
Principal Investigator: Lori Pbert, PhD University of Massachusetts, Worcester
University of Massachusetts, Worcester
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP