Adolescent Smoking Cessation in Pediatric Primary Care

Tobacco Cessation Clinical Trial

— Smokebusters  

Official title:

Adolescent Smoking Cessation in Pediatric Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01312480
• Other study ID #: SB-1R01CA140576-01A2
• Secondary ID: 1R01CA140576-01A
• Status: Completed
• Phase: N/A
• First received: March 8, 2011
• Last updated: January 16, 2018
• Start date: May 2011
• Est. completion date: April 2017

Study information

• Verified date: January 2018
• Source: American Academy of Pediatrics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10967
• Est. completion date: April 2017
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Media Use
• Tobacco Cessation

Intervention

Other:
• 5A's Model
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 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.

Locations

Country	Name	City	State
United States	American Academy of Pediatrics	Elk Grove Village	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
American Academy of Pediatrics	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4-6 weeks after initial doctor's visit, 6 months after initial doctors' visit, 12 months after initial doctor's visit.
Secondary	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.	4-6 weeks after initial doctor visit