Adolescent Smoking Cessation in Pediatric Primary Care (Smokebusters)

This study is currently recruiting participants.
Verified January 2013 by American Academy of Pediatrics
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jonathan D. Klein, American Academy of Pediatrics
ClinicalTrials.gov Identifier:
NCT01312480
First received: March 8, 2011
Last updated: January 11, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Tobacco Cessation
Media Use
Other: 5A's Model
Other: Media Use Assessment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Adolescent Smoking Cessation in Pediatric Primary Care

Resource links provided by NLM:


Further study details as provided by American Academy of Pediatrics:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Adolescent-report of clinician visit. [ Time Frame: 4-6 weeks after initial doctor visit ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 8160
Study Start Date: May 2011
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Intervention Group
The smoking cessation intervention is a Public Health Services-approved intervention based on the 5A 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.
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.

  Eligibility

Ages Eligible for Study:   14 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01312480

Contacts
Contact: Julie Gorzkowski, MSW 847-434-7126 jgorzkowski@aap.org
Contact: Kristen Kaseeska kkaseeska@aap.org

Locations
United States, Illinois
American Academy of Pediatrics Recruiting
Elk Grove Village, Illinois, United States, 60007
Contact: Julie Gorzkowski, MSW    847-434-7126    jgorzkowski@aap.org   
Principal Investigator: Jonathan D. Klein, MD, MPH         
Sub-Investigator: Eric J Slora, PhD         
Sponsors and Collaborators
American Academy of Pediatrics
Investigators
Principal Investigator: Jonathan D. Klein, MD, MPH American Academy of Pediatrics
  More Information

No publications provided

Responsible Party: Jonathan D. Klein, Associate Executive Director, American Academy of Pediatrics
ClinicalTrials.gov Identifier: NCT01312480     History of Changes
Other Study ID Numbers: SB-1R01CA140576-01A2, 1R01CA140576-01A2
Study First Received: March 8, 2011
Last Updated: January 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by American Academy of Pediatrics:
Tobacco
Tobacco Prevention
Tobacco Cessation
5A's Model
Adolescence
Media Use

ClinicalTrials.gov processed this record on April 15, 2014