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
  Purpose

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.


Condition Intervention Phase
Cigarette Smoking
Nicotine Dependence
Behavioral: Counseling Intervention
Behavioral: Information Intervention
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: School Nurse-Delivered Smoking Cessation Intervention

Resource links provided by NLM:


Further study details as provided by University of Massachusetts, Worcester:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Reduction in number of cigarettes and days smoked [ Time Frame: 3 months and 1 year post baseline ] [ Designated as safety issue: No ]

Enrollment: 1058
Study Start Date: September 2006
Study Completion Date: February 2010
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CI
Four 30-minute individual student-centered smoking cessation counseling intervention sessions delivered by school nurses to adolescent smokers in grades 9-12
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
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
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

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.

  Eligibility

Ages Eligible for Study:   13 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00682474

Locations
United States, Massachusetts
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01655
Sponsors and Collaborators
University of Massachusetts, Worcester
Investigators
Principal Investigator: Lori Pbert, PhD University of Massachusetts, Worcester
  More Information

No publications provided by University of Massachusetts, Worcester

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lori Pbert, Professor of Medicine, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT00682474     History of Changes
Other Study ID Numbers: R01CA114556
Study First Received: May 20, 2008
Last Updated: August 18, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Massachusetts, Worcester:
Cigarette smoking
Nicotine dependence
Adolescents
Youth
School health
Randomized controlled trial

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 19, 2014