Adolescent Smoking Cessation in Pediatric Primary Care (Smokebusters)

January 16, 2018 updated by: Jonathan D. Klein, American Academy of Pediatrics

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 screening using charting tools and linkages to adjunct materials, including self-help handouts and Internet resources); and
  2. 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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10967

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Elk Grove Village, Illinois, United States, 60007
        • American Academy of Pediatrics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Intervention Group
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.
Other: 5A's Model

The 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: Control Group
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.
Other: Media Use Assessment
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
4-6 weeks after initial doctor's visit, 6 months after initial doctors' visit, 12 months after initial doctor's visit.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adolescent-report of clinician visit.
Time Frame: 4-6 weeks after initial doctor 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.
4-6 weeks after initial doctor visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
American Academy of Pediatrics

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jonathan D. Klein, MD, MPH, University of Illinois at Chicago and the American Academy of Pediatrics Julius B Richmond Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 8, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 10, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 18, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SB-1R01CA140576-01A2
  • 1R01CA140576-01A2 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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