School Nurse-Delivered Smoking Cessation Intervention

Nicotine Dependence Clinical Trial

Official title:

School Nurse-Delivered Smoking Cessation Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00682474
• Other study ID #: R01CA114556
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 20, 2008
• Last updated: August 18, 2011
• Start date: September 2006
• Est. completion date: February 2010

Study information

• Verified date: August 2011
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1058
• Est. completion date: February 2010
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 13 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cigarette Smoking
• Nicotine Dependence
• Tobacco Use Disorder

Intervention

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
• 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

Locations

Country	Name	City	State
United States	University of Massachusetts Medical School	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abstinence from cigarette smoking in the past 30 days at 3 months and 1 year.		3 months and 1 year post baseline	No
Secondary	Reduction in number of cigarettes and days smoked		3 months and 1 year post baseline	No