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Evaluation of Adolescent Smoking Cessation Programs

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ClinicalTrials.gov Identifier: NCT00714207
Recruitment Status : Completed
First Posted : July 14, 2008
Last Update Posted : July 14, 2008
Sponsor:
Collaborator:
Truth Initiative
Information provided by:
Johns Hopkins University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Smoking Status Behavioral: NOT program Behavioral: NOT controls Behavioral: Kicking Butts intervention Behavioral: KB controls Not Applicable

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  (Clinical Trial)
Actual Enrollment : 407 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Adolescent Smoking Cessation Programs
Study Start Date : July 2002
Actual Primary Completion Date : June 2005
Actual Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: NOT Intervention
Students in this arm of the study were randomized to receive the reformatted NOT program
Behavioral: 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
Behavioral: NOT controls
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
Behavioral: 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
Behavioral: KB controls
Students in this arm were randomized to receive a single group session on smoking cessation and were given youth oriented informational pamphlets



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Salivary cotinine level [ Time Frame: End of program and 1, 6 and 12 months later ]


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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00714207


Locations
United States, Maryland
Northwestern High School
Baltimore, Maryland, United States, 21215
Walbrook High School
Baltimore, Maryland, United States, 21216
Patterson High School
Baltimore, Maryland, United States, 21224
Southern High School/Digital Harbor
Baltimore, Maryland, United States, 21230
Long Reach High School
Columbia, Maryland, United States, 21045
Hammond High School
Columbia, Maryland, United States, 21046
Mount Hebron High School
Ellicott City, Maryland, United States, 21042
Howard High School
Ellicott City, Maryland, United States, 21043
Sponsors and Collaborators
Johns Hopkins University
Truth Initiative
Investigators
Principal Investigator: Alain Joffe, MD Johns Hopkins Bloomberg School of Public Health

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alain Joffe, MD, MPH, Principal Investigator, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT00714207     History of Changes
Other Study ID Numbers: H.32.01.12.04.A1
First Posted: July 14, 2008    Key Record Dates
Last Update Posted: July 14, 2008
Last Verified: July 2008

Keywords provided by Johns Hopkins University:
adolescents
smoking
smoking cessation
tobacco use