Tobacco DependencePhase 2NCT00435344
Provider and Peer Delivered Youth Smoking Intervention
A Phase 2 study testing Pediatric Practice-Based Smoking Intervention in people with Tobacco Dependence, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
The purpose of this study was to determine whether a pediatric practice-based smoking prevention and cessation intervention increases abstinence rates among adolescents. Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Dependence
- What is being tested?
- Pediatric Practice-Based Smoking Intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 2,711 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 1999to Jan 2004
- Phase
- Phase 2
- 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
- Aged 13 to 17, regardless of smoking status
- Scheduled for routine or acute care office visit
- Parental consent and youth assent
Who cannot join
- Unable to complete study requirements
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 was to determine whether a pediatric practice-based smoking prevention and cessation intervention increases abstinence rates among adolescents.
Read the detailed description
The majority of adolescent smokers are interested in quitting and have attempted to stop with limited success. A recent review of cessation trials for adolescents has concluded that there are no proven programs to help teens stop smoking, but suggested interventions based on cognitive behavioral therapy and sensitive to stages of change appear promising. The American Academy of Pediatrics suggests that pediatricians are well-positioned to intervene with adolescent smokers, as well as with nonsmokers to prevent initiation. A comprehensive, practice-based smoking prevention and cessation intervention for adolescents delivered by pediatric providers and peer counselors in the context of routine care has the potential for assisting nonsmoking adolescents in remaining smoke-free and smoking adolescents to quit.
- Conditions
- Tobacco Dependence
- Being tested
- Pediatric Practice-Based Smoking Intervention
- Keywords
- Pediatric practice, Smoking cessation, Smoking prevention, Adolescents
- Medical subject headings
- Tobacco Use Disorder, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pediatric Practice-Based Smoking InterventionBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Abstinence from smoking in the past 30 days at 6 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2007 (estimated)
- Study startFeb 1999
- Study completionJan 2004
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 Tobacco DependenceStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 2,711 participants
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Investigators
- Lori Pbert, Ph.D., Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00435344
- Sponsor's protocol ID
- 1R01CA080254-01A1
- Status last verified
- Feb 2007
- First submitted
- 12 Feb 2007
- Last updated
- 14 Feb 2007
- Results posted
- No
Publications
Pbert L, Flint AJ, Fletcher KE, Young MH, Druker S, DiFranza JR. Effect of a pediatric practice-based smoking prevention and cessation intervention for adolescents: a randomized, controlled trial. Pediatrics. 2008 Apr;121(4):e738-47. doi: 10.1542/peds.2007-1029.
PubMed 18381502
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Provider and Peer Delivered Youth Smoking Intervention
- ClinicalTrials.gov ID
- NCT00435344
- Acronym / sponsor ID
- 1R01CA080254-01A1
- Conditions
- Tobacco Dependence
- Keywords
- Pediatric practice, Smoking cessation, Smoking prevention, Adolescents
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,711 participants
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Study start
- Feb 1999
- Study completion
- Jan 2004
- First posted
- 14 Feb 2007 (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 whether a pediatric practice-based smoking prevention and cessation intervention increases abstinence rates among adolescents.
Detailed description
The majority of adolescent smokers are interested in quitting and have attempted to stop with limited success. A recent review of cessation trials for adolescents has concluded that there are no proven programs to help teens stop smoking, but suggested interventions based on cognitive behavioral therapy and sensitive to stages of change appear promising. The American Academy of Pediatrics suggests that pediatricians are well-positioned to intervene with adolescent smokers, as well as with nonsmokers to prevent initiation. A comprehensive, practice-based smoking prevention and cessation intervention for adolescents delivered by pediatric providers and peer counselors in the context of routine care has the potential for assisting nonsmoking adolescents in remaining smoke-free and smoking adolescents to quit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Aged 13 to 17, regardless of smoking status
- Scheduled for routine or acute care office visit
- Parental consent and youth assent
Key exclusion criteria (1 listed)
- Unable to complete study requirements
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 |
|---|---|---|
| Pediatric Practice-Based Smoking Intervention | Behavioural | – |
Primary outcome
Abstinence from smoking in the past 30 days at 6 months and 1 year
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 Feb 2007.
- Derived from this study: PubMed 18381502Pbert L, Flint AJ, Fletcher KE, Young MH, Druker S, DiFranza JR. Effect of a pediatric practice-based smoking prevention and cessation intervention for adolescents: a randomized, controlled trial. Pediatrics. 2008 Apr;121(4):e738-47. doi: 10.1542/peds.2007-1029.
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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, Ph.D. 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 study testing Pediatric Practice-Based Smoking Intervention in people with Tobacco 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 3 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 Feb 2007. 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 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.
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 smoking in the past 30 days at 6 months and 1 year. 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 NCT00435344, 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 Feb 2007.