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School Nurse-Delivered Smoking Cessation Intervention

School Nurse-Delivered Smoking Cessation Intervention

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00682474
Enrollment
1058
Registered
2008-05-22
Start date
2006-09-30
Completion date
2010-02-28
Last updated
2011-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cigarette Smoking, Nicotine Dependence

Keywords

Cigarette smoking, Nicotine dependence, Adolescents, Youth, School health, Randomized controlled trial

Brief 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.

Interventions

BEHAVIORALCounseling Intervention

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

Sponsors

University of Massachusetts, Worcester
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
13 Years to 18 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Abstinence from cigarette smoking in the past 30 days at 3 months and 1 year.3 months and 1 year post baseline

Secondary

MeasureTime frame
Reduction in number of cigarettes and days smoked3 months and 1 year post baseline

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026