Adolescent Smoking Cessation in Pediatric Primary Care

NCT01312480 | Completed DMC

• 2 other identifiers: SB-1R01CA140576-01A21R01CA140576-01A2
• Study Type: interventional
• Target: 10,967
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study of the effectiveness of adolescent smoking cessation interventions in pediatric primary care settings. Our specific aims are to:

1. 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. 2.Assess the impact of primary care provider counseling interventions on adolescent smoking cessation.

Conditions

Tobacco Cessation; Media Use

Keywords

Tobacco; Tobacco Prevention; Tobacco Cessation; 5A's Model; Adolescence; Media Use

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Adolescent-report of clinician visit.

  4-6 weeks after initial doctor visit

Study Arms (2)

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.

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.

Other: Media Use Assessment

Interventions

5A's Model OTHER

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.

Intervention Group

Media Use Assessment 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.

Control Group

Eligibility Criteria

• Age: 14 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• American Academy of Pediatrics: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

American Academy of Pediatrics

Elk Grove Village, Illinois, 60007, United States

Location

Related Publications (1)

• 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.

  PMID: 32989082 DERIVED

MeSH Terms

Conditions

Tobacco Use Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Jonathan D. Klein, MD, MPH

  University of Illinois at Chicago and the American Academy of Pediatrics Julius B Richmond Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics, University of Illinois at Chicago

Study Record Dates

• First Submitted: March 8, 2011
• First Posted: March 10, 2011
• Study Start: May 1, 2011
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2017
• Last Updated: January 18, 2018

Record last verified: 2018-01

Locations

US (1)