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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Cigarette Smoking, Nicotine Dependence
- 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 group | Role | What they receive |
|---|---|---|
| CI | Experimental | Four 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 |
| II | Active comparator | 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 Receives: Behavioral: Information Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
- First posted22 May 2008 (estimated)
- Study startSep 2006
- Primary completionJun 2009
- Study completionFeb 2010
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 Cigarette SmokingStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,058 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lori Pbert, University of Massachusetts, Worcester
- Investigators
- Lori Pbert, PhD, Principal investigator, University of Massachusetts, Worcester
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- School Nurse-Delivered Smoking Cessation Intervention
- ClinicalTrials.gov ID
- NCT00682474
- Acronym / sponsor ID
- R01CA114556
- Conditions
- Cigarette Smoking, Nicotine Dependence
- Keywords
- Cigarette smoking, Nicotine dependence, Adolescents, Youth, School health, Randomized controlled trial
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,058 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Jun 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 22 May 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 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CI | Experimental | Behavioral: Counseling InterventionFour 30-minute individual student-centered smoking cessation counseling intervention sessions delivered by school nurses to adolescent smokers in grades 9-12 |
| II | Active comparator | Behavioral: Information InterventionAttention-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 |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- unwilling/unable to provide informed assent
- planning to move out of the area in the next 6 months
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 |
|---|---|---|
| Counseling InterventionAlso: Calling It QuitsFour 30-minute individual student-centered smoking cessation counseling intervention sessions delivered by school nurses to adolescent smokers in grades 9-12 | Behavioural | CI |
| Information InterventionAttention-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 | Behavioural | II |
Primary outcome
Abstinence from cigarette smoking in the past 30 days at 3 months and 1 year.
Time frame: 3 months and 1 year post baseline
1 secondary outcome
Reduction in number of cigarettes and days smoked
Time frame: 3 months and 1 year post baseline
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 19 Aug 2011.
- Derived from this study: PubMed 22007015Pbert 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.
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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.
Lori Pbert, PhD principal investigator
University of Massachusetts, Worcester
1 site in 1 country: see every site and its status.
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.