- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00714207
Evaluation of Adolescent Smoking Cessation Programs
July 10, 2008 updated by: Johns Hopkins University
The purpose of this study was to determine if a school-based multi-session group smoking cessation program is more effective than a single session group program.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The investigators reformatted two group smoking cessation programs (the NOT program of the American Lung Association and Kicking Butts), both of which involve 50 minute sessions delivered once weekly, into a program that could be delivered during school lunch periods (25-30 minutes) twice weekly.
Smoking status was subsequently assessed over the 12 month period following the intervention,
Study Type
Interventional
Enrollment (Actual)
407
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21215
- Northwestern High School
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Baltimore, Maryland, United States, 21216
- Walbrook High School
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Baltimore, Maryland, United States, 21224
- Patterson High School
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Baltimore, Maryland, United States, 21230
- Southern High School/Digital Harbor
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Columbia, Maryland, United States, 21045
- Long Reach High School
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Columbia, Maryland, United States, 21046
- Hammond High School
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Ellicott City, Maryland, United States, 21042
- Mount Hebron High School
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Ellicott City, Maryland, United States, 21043
- Howard High School
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
11 years to 15 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Students who indicated they smoked cigarettes and wanted to quit
Exclusion Criteria:
- Students referred as part of a disciplinary requirement to stop smoking
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: NOT Intervention
Students in this arm of the study were randomized to receive the reformatted NOT program
|
Students in this arm of the study received the reformatted NOT intervention
|
Active Comparator: NOT controls
Students in this arm were randomized to receive a single group session on smoking cessation and were given youth oriented informational pamphlets on smoking cessation
|
Students in this arm were randomized to receive a single group session on smoking cessation and were given youth oriented informational pamphlets
|
Experimental: KB intervention
Students in this arm of the study were randomized to receive the reformatted Kicking Butts intervention
|
Students in this arm of the study were randomized to receive the reformatted Kicking Butts intervention
|
Active Comparator: KB controls
Students in this arm were randomized to receive a single group session on smoking cessation and were given youth oriented informational pamphlets on smoking cessation
|
Students in this arm were randomized to receive a single group session on smoking cessation and were given youth oriented informational pamphlets
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Self reported quit status (Student identifies self as non-smoker and no smoking for 30 days)
Time Frame: End of program and 1, 3, 6 and 12 months later
|
End of program and 1, 3, 6 and 12 months later
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Salivary cotinine level
Time Frame: End of program and 1, 6 and 12 months later
|
End of program and 1, 6 and 12 months later
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Alain Joffe, MD, Johns Hopkins Bloomberg School of Public Health
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2002
Primary Completion (Actual)
June 1, 2005
Study Completion (Actual)
June 1, 2005
Study Registration Dates
First Submitted
July 10, 2008
First Submitted That Met QC Criteria
July 10, 2008
First Posted (Estimate)
July 14, 2008
Study Record Updates
Last Update Posted (Estimate)
July 14, 2008
Last Update Submitted That Met QC Criteria
July 10, 2008
Last Verified
July 1, 2008
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- H.32.01.12.04.A1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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