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Adolescent Smoking Cessation in Pediatric Primary Care (Smokebusters)

This study is currently recruiting participants. (see Contacts and Locations)
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

March 8, 2011
January 11, 2013
May 2011
April 2015   (final data collection date for 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. ] [ 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.
Same as current
Complete list of historical versions of study NCT01312480 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Adolescent Smoking Cessation in Pediatric Primary Care
Adolescent Smoking Cessation in Pediatric Primary Care

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Supportive Care
  • Tobacco Cessation
  • Media Use
  • 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: 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.
  • 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.
    Intervention: Other: 5A's Model
  • 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.
    Intervention: Other: Media Use Assessment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
8160
April 2015
April 2015   (final data collection date for primary outcome measure)

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.
Both
14 Years to 25 Years
Yes
Contact: Julie Gorzkowski, MSW 847-434-7126 jgorzkowski@aap.org
Contact: Kristen Kaseeska kkaseeska@aap.org
United States
 
NCT01312480
SB-1R01CA140576-01A2, 1R01CA140576-01A2
Yes
Jonathan D. Klein, American Academy of Pediatrics
American Academy of Pediatrics
National Cancer Institute (NCI)
Principal Investigator: Jonathan D. Klein, MD, MPH American Academy of Pediatrics
American Academy of Pediatrics
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP