School Nurse-Delivered Smoking Cessation Intervention
Primary Purpose
Cigarette Smoking, Nicotine Dependence
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Counseling Intervention
Information Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Cigarette Smoking focused on measuring Cigarette smoking, Nicotine dependence, Adolescents, Youth, School health, Randomized controlled trial
Eligibility 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
Sites / Locations
- University of Massachusetts Medical School
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CI
II
Arm Description
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
Outcomes
Primary Outcome Measures
Abstinence from cigarette smoking in the past 30 days at 3 months and 1 year.
Secondary Outcome Measures
Reduction in number of cigarettes and days smoked
Full Information
NCT ID
NCT00682474
First Posted
May 20, 2008
Last Updated
August 18, 2011
Sponsor
University of Massachusetts, Worcester
1. Study Identification
Unique Protocol Identification Number
NCT00682474
Brief Title
School Nurse-Delivered Smoking Cessation Intervention
Official Title
School Nurse-Delivered Smoking Cessation Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Worcester
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cigarette Smoking, Nicotine Dependence
Keywords
Cigarette smoking, Nicotine dependence, Adolescents, Youth, School health, Randomized controlled trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1058 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CI
Arm Type
Experimental
Arm Description
Four 30-minute individual student-centered smoking cessation counseling intervention sessions delivered by school nurses to adolescent smokers in grades 9-12
Arm Title
II
Arm Type
Active Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
Counseling Intervention
Other Intervention Name(s)
Calling It Quits
Intervention Description
Four 30-minute individual student-centered smoking cessation counseling intervention sessions delivered by school nurses to adolescent smokers in grades 9-12
Intervention Type
Behavioral
Intervention Name(s)
Information Intervention
Intervention Description
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
Primary Outcome Measure Information:
Title
Abstinence from cigarette smoking in the past 30 days at 3 months and 1 year.
Time Frame
3 months and 1 year post baseline
Secondary Outcome Measure Information:
Title
Reduction in number of cigarettes and days smoked
Time Frame
3 months and 1 year post baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lori Pbert, PhD
Organizational Affiliation
University of Massachusetts, Worcester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Massachusetts Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22007015
Citation
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. doi: 10.1542/peds.2011-0520. Epub 2011 Oct 17.
Results Reference
derived
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School Nurse-Delivered Smoking Cessation Intervention
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