Evaluation of Adolescent Smoking Cessation Programs

Smoking Status Clinical Trial

Official title:

Evaluation of Adolescent Smoking Cessation Programs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00714207
• Other study ID #: H.32.01.12.04.A1
• Status: Completed
• Phase: N/A
• First received: July 10, 2008
• Last updated: July 10, 2008
• Start date: July 2002
• Est. completion date: June 2005

Study information

• Verified date: July 2008
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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,

Recruitment information / eligibility

• Status: Completed
• Enrollment: 407
• Est. completion date: June 2005
• Est. primary completion date: June 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 13 Years to 17 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking Status

Intervention

Behavioral:
• NOT program
Students in this arm of the study received the reformatted NOT intervention
• NOT controls
Students in this arm were randomized to receive a single group session on smoking cessation and were given youth oriented informational pamphlets
• Kicking Butts intervention
Students in this arm of the study were randomized to receive the reformatted Kicking Butts intervention
• KB controls
Students in this arm were randomized to receive a single group session on smoking cessation and were given youth oriented informational pamphlets

Locations

Country	Name	City	State
United States	Northwestern High School	Baltimore	Maryland
United States	Patterson High School	Baltimore	Maryland
United States	Southern High School/Digital Harbor	Baltimore	Maryland
United States	Walbrook High School	Baltimore	Maryland
United States	Hammond High School	Columbia	Maryland
United States	Long Reach High School	Columbia	Maryland
United States	Howard High School	Ellicott City	Maryland
United States	Mount Hebron High School	Ellicott City	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Truth Initiative

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self reported quit status (Student identifies self as non-smoker and no smoking for 30 days)		End of program and 1, 3, 6 and 12 months later	No
Secondary	Salivary cotinine level		End of program and 1, 6 and 12 months later	No