Overview

This trial is active, not recruiting.

Conditions tobacco cessation, media use
Treatments 5a's model, media use assessment
Sponsor American Academy of Pediatrics
Collaborator National Cancer Institute (NCI)
Start date May 2011
End date April 2016
Trial size 8160 participants
Trial identifier NCT01312480, 1R01CA140576-01A2, SB-1R01CA140576-01A2

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, outcomes assessor)
Primary purpose supportive care
Arm
(Other)
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.
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.
(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.
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.

Primary Outcomes

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.

Secondary Outcomes

Measure
Adolescent-report of clinician visit.
time frame: 4-6 weeks after initial doctor visit

Eligibility Criteria

Male or female participants from 14 years up to 25 years old.

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.

Additional Information

Official title Adolescent Smoking Cessation in Pediatric Primary Care
Principal investigator Jonathan D. Klein, MD, MPH
Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by American Academy of Pediatrics.