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

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
      • Baltimore, Maryland, United States, 21216
        • Walbrook High School
      • Baltimore, Maryland, United States, 21224
        • Patterson High School
      • Baltimore, Maryland, United States, 21230
        • Southern High School/Digital Harbor
      • Columbia, Maryland, United States, 21045
        • Long Reach High School
      • Columbia, Maryland, United States, 21046
        • Hammond High School
      • Ellicott City, Maryland, United States, 21042
        • Mount Hebron High School
      • 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.

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

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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