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Cigarette SmokingPhase 2/3NCT00682474

School Nurse-Delivered Smoking Cessation Intervention

A Phase 2/3 study testing Counseling Intervention and Information Intervention in people with Cigarette Smoking and Nicotine Dependence, run by University of Massachusetts, Worcester at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to conduct a randomized controlled school-based trial to evaluate the effectiveness of a four-session school nurse-delivered smoking cessation intervention in increasing abstinence rates among high school students who smoke. Read more about this study

Who is it for?
Ages 13 to 18 yearsHealthy volunteers can take part
Conditions the study is for
Cigarette Smoking, Nicotine Dependence
What is being tested?
Counseling Intervention and Information Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,058 participants
Where
1 siteUnited States
Study dates
Sep 2006to Feb 2010
Phase
Phase 2/3
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 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • enrolled in grades 9-12
  • report smoking at least one puff of a cigarette in the past 30 days
  • willingness to participate in a smoking cessation intervention study
  • able to speak and read English
  • able to complete the baseline questionnaire independently, indicating ability to complete study assessments and protocols
  • intending to remain enrolled in the school for the remainder of the school year
  • willing to provide contact information for the next 12 months

Who cannot join

  • unwilling/unable to provide informed assent
  • planning to move out of the area in the next 6 months

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Massachusetts Medical School

    Worcester, Massachusetts, 01655

Other trials in United States

About this study

The purpose of this study is to conduct a randomized controlled school-based trial to evaluate the effectiveness of a four-session school nurse-delivered smoking cessation intervention in increasing abstinence rates among high school students who smoke.

Read the detailed description

Smoking is the largest preventable cause of disease and premature death in the United States. Adolescent smoking is the greatest predictor of adult smoking and is associated with adverse health effects during adolescence. Twenty-two percent of high school students report current smoking (past 30 days). As the primary health professional in the school setting, school nurses have a tremendous opportunity to play a key role in treating adolescent smokers. A randomized controlled trial (RCT) conducted by the investigators in 71 high schools in Massachusetts demonstrated the feasibility of school nurses delivering a four-session individual counseling intervention to adolescents who want to stop smoking and its potential efficacy in increasing self-reported short term (6-week and 3-month) quit rates. Although promising, the preliminary study lacked biochemical validation and long-term follow-up on the maintenance of the intervention effects, and was conducted with a primarily white student population. This application seeks to evaluate the effectiveness of the intervention using a more rigorous methodology, including biochemical validation of self-reported smoking behavior and longer-term follow-up (6 and 12 months post-intervention), a study design that compares the intervention to an information only attention-control condition, and recruitment from ethnically diverse schools to increase the generalizability of our findings.

The overall aim of the proposed study is to conduct a randomized controlled school-based trial (RCT) to evaluate the effectiveness of a school nurse-delivered smoking cessation intervention in increasing 30 day abstinence rates among high school students who smoke. Forty high schools serving a diverse student population will be recruited and randomly assigned to one of two conditions: (1) Special Intervention (SI) - four 30-minute individual patient-centered smoking cessation counseling intervention sessions based on the Public Health Service (PHS) clinical practice guideline delivered by school nurses; or (2) Information Only (IO) attention-control comparison condition - four individual sessions with the school nurse to check smoking status and deliver a standardized series of informational pamphlets on smoking and cessation. Participant assessments will occur at study entry (baseline) and at 3-,12-month follow-up. Thirty students enrolled in grades 9 through 12 who report smoking within the past 30 days and willingness to participate in a smoking cessation intervention study will be recruited from each school (n=1200) to provide 25 completed assessments per school at 12-month follow-up (n=1000). If found effective, the study products (i.e., intervention protocol, student materials, training manual, and estimated costs of intervention implementation) will facilitate dissemination of the intervention to school nurses nationally.

Being tested
Counseling Intervention, Information Intervention
Keywords
Cigarette smoking, Nicotine dependence, Adolescents, Youth, School health, Randomized controlled trial
Medical subject headings
Cigarette Smoking, Tobacco Use Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Counseling InterventionBehavioural

    Also called Calling It Quits

    Four 30-minute individual student-centered smoking cessation counseling intervention sessions delivered by school nurses to adolescent smokers in grades 9-12

  • Information InterventionBehavioural

    Attention-control comparison condition consisting of four individual sessions with the school nurse to check smoking status and deliver a series of standardized pamphlets on smoking and cessation to adolescent smokers in grades 9-12

Study groups in NCT00682474
Study groupRoleWhat they receive
CIExperimentalFour 30-minute individual student-centered smoking cessation counseling intervention sessions delivered by school nurses to adolescent smokers in grades 9-12
Receives: Behavioral: Counseling Intervention
IIActive comparatorAttention-control comparison condition consisting of four individual sessions with the school nurse to check smoking status and deliver a series of standardized pamphlets on smoking and cessation to adolescent smokers in grades 9-12
Receives: Behavioral: Information Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Abstinence from cigarette smoking in the past 30 days at 3 months and 1 year.

    Measured: 3 months and 1 year post baseline

Secondary outcomes (1)
  1. Reduction in number of cigarettes and days smoked

    Measured: 3 months and 1 year post baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2008 (estimated)
  2. Study startSep 2006
  3. Primary completionJun 2009
  4. Study completionFeb 2010

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
1,058 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00682474
Sponsor's protocol ID
R01CA114556
Status last verified
Aug 2011
First submitted
20 May 2008
Last updated
19 Aug 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • Pbert L, Druker S, DiFranza JR, Gorak D, Reed G, Magner R, Sheetz AH, Osganian S. Effectiveness of a school nurse-delivered smoking-cessation intervention for adolescents. Pediatrics. 2011 Nov;128(5):926-36. doi: 10.1542/peds.2011-0520. Epub 2011 Oct 17.

    PubMed 22007015

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Counseling Intervention and Information Intervention in people with Cigarette Smoking and Nicotine Dependence, run by University of Massachusetts, Worcester at 1 site 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 7 inclusion and 2 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 19 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Abstinence from cigarette smoking in the past 30 days at 3 months and 1 year. (time frame: 3 months and 1 year post baseline). 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 NCT00682474, 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 19 Aug 2011.

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