Tobacco CessationSmokebustersNCT01312480
Adolescent Smoking Cessation in Pediatric Primary Care
A study testing 5A's Model and Media Use Assessment in people with Tobacco Cessation and Media Use, run by American Academy of Pediatrics at 1 site in United States.
Trial summary
This is a study of the effectiveness of adolescent smoking cessation interventions in pediatric primary care settings. Our specific aims are to: 1. Demonstrate providers' fidelity to guidelines for tobacco counseling and delivery of cessation interventions using practice system changes over time, (including systematic… Read more about this study
- Who is it for?
- Ages 14 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Cessation, Media Use
- What is being tested?
- 5A's Model and Media Use Assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,967 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Apr 2017
- 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 14 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Adolescents presenting for regular well or sick visits at their pediatrician's office.
- Must live in a home or apartment with access to a telephone and mailing address.
- Must be able to speak English.
- Must be able and willing to give informed consent (if 18 years of age or older) or assent (if 14-17 years of age).
- In addition: parents/legal guardians of minors must be able and willing to give informed consent either in person or by phone in cases where the teen presents for care without a parent/legal guardian.
Who cannot join
- Adolescents who fall outside of the age range specified above.
- Unable to speak English.
- Do not have access to a telephone and/or mailing address.
Trial locations and contacts
1 site in 1 country.
United States1 site
American Academy of Pediatrics
Elk Grove Village, Illinois, 60007
About this study
This is a study of the effectiveness of adolescent smoking cessation interventions in pediatric primary care settings. Our specific aims are to:
- Demonstrate providers' fidelity to guidelines for tobacco counseling and delivery of cessation interventions using practice system changes over time, (including systematic screening using charting tools and linkages to adjunct materials, including self-help handouts and Internet resources); and
- Assess the impact of primary care provider counseling interventions on adolescent smoking cessation.
Read more
We hypothesize that adolescents who receive guidelines-based clinician-delivered smoking cessation counseling at primary care visits will be more likely to make quit attempts and more likely to remain abstinent (with better long term cessation rates) at 6 and 12 months after intervention, compared to those who do not receive interventions. In addition, we hypothesize that successful referral to stage-based self-help adjuncts, and more adjunct use will be associated with more quit attempts and better long-term cessation rates.
We will evaluate provider interventions in up to 120 pediatric practices, recruited from the American Academy of Pediatric's Pediatric Research in Office Settings (PROS) practice-based research network. Adolescents presenting for care will complete a short baseline survey prior to their doctor-visit, and a percentage of participants will be surveyed by phone 4-6 weeks after their visits to assess quit attempts and short-term cessation, and again at 6 and 12 months to evaluate long-term cessation outcomes. We will describe the patterns of smoking among youth, and explore how much receiving interventions affects motivation, quitting, abstinence/relapse attitudes, attitudes and use of adjunct strategies, and other smoking behaviors for adolescent smokers.
- Conditions
- Tobacco Cessation, Media Use
- Being tested
- 5A's Model, Media Use Assessment
- Keywords
- Tobacco, Tobacco Prevention, Tobacco Cessation, 5A's Model, Adolescence, Media Use
- Medical subject headings
- Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5A's ModelOther
The smoking cessation intervention is based on the 5A's model, which includes the following elements:
- Ask if the patient smokes.
- Advise every patient to quit.
- Assess readiness to quit.
- Assist in quitting and finding services.
- Arrange for cessation services and follow-up.
Media Use AssessmentOther
The media use assessment (control condition) is based in part on the American Academy of Pediatrics policy statement on children and media, published in the November 2010 issue of Pediatrics. This assessment includes suggested questions on how much media per day is used and whether or not the adolescent has a television or Internet access in his/her bedroom. The adolescent will complete a one-page Media Use assessment form for this purpose, which will set the stage for relevant anticipatory guidance.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Other | The smoking cessation intervention is a Public Health Services-approved intervention based on the 5A's Model, which includes (1) Ask if the patient smokes, (2) Advise every patient to quit, (3) Assess readiness to quit, (4) Assist in quitting and finding services and (5) Arrange for cessation services and follow up. Practitioners will complete a 5A checklist for each patient in this arm. Receives: Other: 5A's Model |
| Control Group | Other | The media use assessment (control condition) is based in part on the American Academy of Pediatrics policy statement on children and media, published in the November 2010 issue of Pediatrics. This assessment includes suggested questions on how much media per day is used and whether or not the adolescent has a television or Internet access in his/her bedroom. The adolescent will complete a one-page Media Use assessment form for this purpose, which will set the stage for relevant anticipatory guidance. Receives: Other: Media Use Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self-reported smoking status since baseline.
Via phone interview, adolescents will be asked to report their current smoking status, any quit-attempts, success of those quit-attempts, abstinence from tobacco products, and use of adjunct resources in the time since their initial doctor's visit.
Measured: 4-6 weeks after initial doctor's visit, 6 months after initial doctors' visit, 12 months after initial doctor's visit.
Secondary outcomes (1)
Adolescent-report of clinician visit.
In a phone interview, adolescents will be asked to report on the screenings, counseling, and referral to any cessation adjuncts that occured during their doctor visit.
Measured: 4-6 weeks after initial doctor visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2011 (estimated)
- Study startMay 2011
- Primary completionApr 2016
- Study completionApr 2017
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 CessationStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 10,967 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Academy of Pediatrics
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Jonathan D. Klein, American Academy of Pediatrics
- Investigators
- Jonathan D. Klein, MD, MPH, Principal investigator, University of Illinois at Chicago and the American Academy of Pediatrics Julius B Richmond Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01312480
- Sponsor's protocol ID
- SB-1R01CA140576-01A2
- Other IDs
- 1R01CA140576-01A2
- Acronym
- Smokebusters
- Status last verified
- Jan 2018
- First submitted
- 8 Mar 2011
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Klein JD, Gorzkowski J, Resnick EA, Harris D, Kaseeska K, Pbert L, Prokorov A, Wang T, Davis J, Gotlieb E, Wasserman R. Delivery and Impact of a Motivational Intervention for Smoking Cessation: A PROS Study. Pediatrics. 2020 Oct;146(4):e20200644. doi: 10.1542/peds.2020-0644.
PubMed 32989082
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adolescent Smoking Cessation in Pediatric Primary Care
- ClinicalTrials.gov ID
- NCT01312480
- Acronym / sponsor ID
- Smokebusters / SB-1R01CA140576-01A2
- Conditions
- Tobacco Cessation, Media Use
- Keywords
- Tobacco, Tobacco Prevention, Tobacco Cessation, 5A's Model, Adolescence, Media Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10,967 participants (actual)
- Lead sponsor
- American Academy of PediatricsUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2011
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 10 Mar 2011 (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.
This is a study of the effectiveness of adolescent smoking cessation interventions in pediatric primary care settings. Our specific aims are to:
- Demonstrate providers' fidelity to guidelines for tobacco counseling and delivery of cessation interventions using practice system changes over time, (including systematic screening using charting tools and linkages to adjunct materials, including self-help handouts and Internet resources); and
- Assess the impact of primary care provider counseling interventions on adolescent smoking cessation.
We hypothesize that adolescents who receive guidelines-based clinician-delivered smoking cessation counseling at primary care visits will be more likely to make quit attempts and more likely to remain abstinent (with better long term cessation rates) at 6 and 12 months after intervention, compared to those who do not receive interventions. In addition, we hypothesize that successful referral to stage-based self-help adjuncts, and more adjunct use will be associated with more quit attempts and better long-term cessation rates.
We will evaluate provider interventions in up to 120 pediatric practices, recruited from the American Academy of Pediatric's Pediatric Research in Office Settings (PROS) practice-based research network. Adolescents presenting for care will complete a short baseline survey prior to their doctor-visit, and a percentage of participants will be surveyed by phone 4-6 weeks after their visits to assess quit attempts and short-term cessation, and again at 6 and 12 months to evaluate long-term cessation outcomes. We will describe the patterns of smoking among youth, and explore how much receiving interventions affects motivation, quitting, abstinence/relapse attitudes, attitudes and use of adjunct strategies, and other smoking behaviors for adolescent smokers.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Other | Other: 5A's ModelThe smoking cessation intervention is a Public Health Services-approved intervention based on the 5A's Model, which includes (1) Ask if the patient smokes, (2) Advise every patient to quit, (3) Assess readiness to quit, (4) Assist in quitting and finding services and (5) Arrange for cessation services and follow up. Practitioners will complete a 5A checklist for each patient in this arm. |
| Control Group | Other | Other: Media Use AssessmentThe media use assessment (control condition) is based in part on the American Academy of Pediatrics policy statement on children and media, published in the November 2010 issue of Pediatrics. This assessment includes suggested questions on how much media per day is used and whether or not the adolescent has a television or Internet access in his/her bedroom. The adolescent will complete a one-page Media Use assessment form for this purpose, which will set the stage for relevant anticipatory guidance. |
Who may qualify
- Ages
- 14 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Adolescents presenting for regular well or sick visits at their pediatrician's office.
- Must live in a home or apartment with access to a telephone and mailing address.
- Must be able to speak English.
- Must be able and willing to give informed consent (if 18 years of age or older) or assent (if 14-17 years of age).
- In addition: parents/legal guardians of minors must be able and willing to give informed consent either in person or by phone in cases where the teen presents for care without a parent/legal guardian.
Key exclusion criteria (3 listed)
- Adolescents who fall outside of the age range specified above.
- Unable to speak English.
- Do not have access to a telephone and/or mailing address.
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 |
|---|---|---|
| 5A's ModelThe smoking cessation intervention is based on the 5A's model, which includes the following elements: 1. Ask if the patient smokes. 2. Advise every patient to quit. 3. Assess readiness to quit. 4. Assist in quitting and finding services. 5. Arrange for cessation services and follow-up. | Other | Intervention Group |
| Media Use AssessmentThe media use assessment (control condition) is based in part on the American Academy of Pediatrics policy statement on children and media, published in the November 2010 issue of Pediatrics. This assessment includes suggested questions on how much media per day is used and whether or not the adolescent has a television or Internet access in his/her bedroom. The adolescent will complete a one-page Media Use assessment form for this purpose, which will set the stage for relevant anticipatory guidance. | Other | Control Group |
Primary outcome
Change in self-reported smoking status since baseline.
Time frame: 4-6 weeks after initial doctor's visit, 6 months after initial doctors' visit, 12 months after initial doctor's visit.
Via phone interview, adolescents will be asked to report their current smoking status, any quit-attempts, success of those quit-attempts, abstinence from tobacco products, and use of adjunct resources in the time since their initial doctor's visit.
1 secondary outcome
Adolescent-report of clinician visit.
Time frame: 4-6 weeks after initial doctor visit
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 18 Jan 2018.
- Derived from this study: PubMed 32989082Klein JD, Gorzkowski J, Resnick EA, Harris D, Kaseeska K, Pbert L, Prokorov A, Wang T, Davis J, Gotlieb E, Wasserman R. Delivery and Impact of a Motivational Intervention for Smoking Cessation: A PROS Study. Pediatrics. 2020 Oct;146(4):e20200644. doi: 10.1542/peds.2020-0644.
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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.
Jonathan D. Klein, MD, MPH principal investigator
University of Illinois at Chicago and the American Academy of Pediatrics Julius B Richmond Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5A's Model and Media Use Assessment in people with Tobacco Cessation and Media Use, run by American Academy of Pediatrics 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 5 inclusion and 3 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 18 Jan 2018. 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.
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?
Change in self-reported smoking status since baseline. (time frame: 4-6 weeks after initial doctor's visit, 6 months after initial doctors' visit, 12 months after initial doctor's visit.). 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 NCT01312480, 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 18 Jan 2018.