Smoking StatusNCT00714207
Evaluation of Adolescent Smoking Cessation Programs
A study testing NOT program and Kicking Butts intervention in people with Smoking Status, run by Johns Hopkins University at 8 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Status
- What is being tested?
- NOT program and Kicking Butts intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 407 participants
- Where
- 8 sitesUnited States
- Study dates
- Jul 2002to Jun 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Students who indicated they smoked cigarettes and wanted to quit
Who cannot join
- Students referred as part of a disciplinary requirement to stop smoking
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Northwestern High School
Baltimore, Maryland, 21215
Walbrook High School
Baltimore, Maryland, 21216
Patterson High School
Baltimore, Maryland, 21224
Southern High School/Digital Harbor
Baltimore, Maryland, 21230
Long Reach High School
Columbia, Maryland, 21045
Hammond High School
Columbia, Maryland, 21046
Mount Hebron High School
Ellicott City, Maryland, 21042
Howard High School
Ellicott City, Maryland, 21043
About this study
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.
Read the 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,
- Conditions
- Smoking Status
- Being tested
- NOT program, NOT controls, Kicking Butts intervention, KB controls
- Keywords
- adolescents, smoking, smoking cessation, tobacco use
- Medical subject headings
- Smoking, Smoking Cessation, Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOT programBehavioural
Students in this arm of the study received the reformatted NOT intervention
NOT controlsBehavioural
Students in this arm were randomized to receive a single group session on smoking cessation and were given youth oriented informational pamphlets
Kicking Butts interventionBehavioural
Students in this arm of the study were randomized to receive the reformatted Kicking Butts intervention
KB controlsBehavioural
Students in this arm were randomized to receive a single group session on smoking cessation and were given youth oriented informational pamphlets
| Study group | Role | What they receive |
|---|---|---|
| NOT Intervention | Experimental | Students in this arm of the study were randomized to receive the reformatted NOT program Receives: 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 Receives: Behavioral: NOT controls |
| KB intervention | Experimental | Students in this arm of the study were randomized to receive the reformatted Kicking Butts intervention Receives: 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 Receives: Behavioral: KB controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self reported quit status (Student identifies self as non-smoker and no smoking for 30 days)
Measured: End of program and 1, 3, 6 and 12 months later
Secondary outcomes (1)
Salivary cotinine level
Measured: End of program and 1, 6 and 12 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2008 (estimated)
- Study startJul 2002
- Primary completionJun 2005
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking StatusStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 407 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Truth Initiative
- Investigators
- Alain Joffe, MD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00714207
- Sponsor's protocol ID
- H.32.01.12.04.A1
- Status last verified
- Jul 2008
- First submitted
- 10 Jul 2008
- Last updated
- 14 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19651564
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Adolescent Smoking Cessation Programs
- ClinicalTrials.gov ID
- NCT00714207
- Acronym / sponsor ID
- H.32.01.12.04.A1
- Conditions
- Smoking Status
- Keywords
- adolescents, smoking, smoking cessation, tobacco use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 407 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Truth Initiative
- Study start
- Jul 2002
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 14 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| NOT Intervention | Experimental | Behavioral: NOT programStudents in this arm of the study were randomized to receive the reformatted NOT program |
| NOT controls | Active comparator | Behavioral: NOT controlsStudents in this arm were randomized to receive a single group session on smoking cessation and were given youth oriented informational pamphlets on smoking cessation |
| KB intervention | Experimental | Behavioral: Kicking Butts interventionStudents in this arm of the study were randomized to receive the reformatted Kicking Butts intervention |
| KB controls | Active comparator | Behavioral: KB controlsStudents in this arm were randomized to receive a single group session on smoking cessation and were given youth oriented informational pamphlets on smoking cessation |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Students who indicated they smoked cigarettes and wanted to quit
Key exclusion criteria (1 listed)
- Students referred as part of a disciplinary requirement to stop smoking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NOT programStudents in this arm of the study received the reformatted NOT intervention | Behavioural | NOT Intervention |
| NOT controlsStudents in this arm were randomized to receive a single group session on smoking cessation and were given youth oriented informational pamphlets | Behavioural | NOT controls |
| Kicking Butts interventionStudents in this arm of the study were randomized to receive the reformatted Kicking Butts intervention | Behavioural | KB intervention |
| KB controlsStudents in this arm were randomized to receive a single group session on smoking cessation and were given youth oriented informational pamphlets | Behavioural | KB controls |
Primary outcome
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
1 secondary outcome
Salivary cotinine level
Time frame: End of program and 1, 6 and 12 months later
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2008.
- Derived from this study: PubMed 19651564Joffe 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alain Joffe, MD principal investigator
Johns Hopkins Bloomberg School of Public Health
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NOT program and Kicking Butts intervention in people with Smoking Status, run by Johns Hopkins University at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00714207, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2008.