Clinical trial NCT01312480: Adolescent Smoking Cessation in Pediatric Primary Care
Official title: Adolescent Smoking Cessation in Pediatric Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Cessation
Media Use
Keywords: Tobacco
Tobacco Prevention
Tobacco Cessation
5A's Model
Adolescence
Media Use
Lead sponsor: American Academy of Pediatrics
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-03-10
Enrollment: 10967
Sex: ALL
Minimum age (years): 14
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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. 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.


Eligibility 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.

Primary outcomes:
measure: Change in self-reported smoking status since baseline.
timeFrame: 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.
timeFrame: 4-6 weeks after initial doctor visit
Other outcomes:
Locations:
city: Elk Grove Village
country: United States
facility: American Academy of Pediatrics
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago and the American Academy of Pediatrics Julius B Richmond Center
name: Jonathan D. Klein, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.