NCT00714207

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
407

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2002

Typical duration for not_applicable

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

July 10, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 14, 2008

Completed
Last Updated

July 14, 2008

Status Verified

July 1, 2008

Enrollment Period

2.9 years

First QC Date

July 10, 2008

Last Update Submit

July 10, 2008

Conditions

Keywords

adolescentssmokingsmoking cessationtobacco use

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Salivary cotinine level

    End of program and 1, 6 and 12 months later

Study Arms (4)

NOT Intervention

EXPERIMENTAL

Students in this arm of the study were randomized to receive the reformatted NOT program

Behavioral: NOT program

NOT controls

ACTIVE COMPARATOR

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

KB intervention

EXPERIMENTAL

Students in this arm of the study were randomized to receive the reformatted Kicking Butts intervention

Behavioral: Kicking Butts intervention

KB controls

ACTIVE COMPARATOR

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

Interventions

NOT programBEHAVIORAL

Students in this arm of the study received the reformatted NOT intervention

NOT Intervention
NOT controlsBEHAVIORAL

Students in this arm were randomized to receive a single group session on smoking cessation and were given youth oriented informational pamphlets

NOT controls

Students in this arm of the study were randomized to receive the reformatted Kicking Butts intervention

KB intervention
KB controlsBEHAVIORAL

Students in this arm were randomized to receive a single group session on smoking cessation and were given youth oriented informational pamphlets

KB controls

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Students who indicated they smoked cigarettes and wanted to quit

You may not qualify if:

  • Students referred as part of a disciplinary requirement to stop smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Northwestern High School

Baltimore, Maryland, 21215, United States

Location

Walbrook High School

Baltimore, Maryland, 21216, United States

Location

Patterson High School

Baltimore, Maryland, 21224, United States

Location

Southern High School/Digital Harbor

Baltimore, Maryland, 21230, United States

Location

Long Reach High School

Columbia, Maryland, 21045, United States

Location

Hammond High School

Columbia, Maryland, 21046, United States

Location

Mount Hebron High School

Ellicott City, Maryland, 21042, United States

Location

Howard High School

Ellicott City, Maryland, 21043, United States

Location

Related Publications (1)

  • Joffe A, McNeely C, Colantuoni E, An MW, Wang W, Scharfstein D. Evaluation of school-based smoking-cessation interventions for self-described adolescent smokers. Pediatrics. 2009 Aug;124(2):e187-94. doi: 10.1542/peds.2008-2509. Epub 2009 Jul 27.

MeSH Terms

Conditions

SmokingSmoking CessationTobacco Use

Condition Hierarchy (Ancestors)

BehaviorHealth Behavior

Study Officials

  • Alain Joffe, MD

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 10, 2008

First Posted

July 14, 2008

Study Start

July 1, 2002

Primary Completion

June 1, 2005

Study Completion

June 1, 2005

Last Updated

July 14, 2008

Record last verified: 2008-07

Locations