Smoking Cessation Clinical Trial
Official title:
Adolescent Smoking Cessation in Pediatric Primary Care
Verified date | June 2010 |
Source | University of Rochester |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
This is a pilot study addressing office systems and clinician behavior change surrounding
smoking cessation interventions for teens. The investigators' long-term goal is to improve
the quality of clinical preventive services in practice-based research network settings.
Their specific aims are to:
- a) pilot procedures for recruitment and randomization of PROS practices; and b) field
trial/pilot PROS practitioner cessation counseling and practices' enrollment of
adolescent patients; and
- assess the feasibility of pediatric clinician referral of adolescent patients to
internet-based adjuncts for smoking cessation.
The investigators will evaluate a pilot round of recruitment and randomization, and smoking
cessation training and delivery in 10 PROS practice sites; and assess the acceptability of
study procedures and on-line internet counseling adjunct referral feasibility within PROS
practice sites. Up to 1000 adolescents presenting for well visits will complete a short
baseline survey prior to their well-visit. A sample of them will be surveyed by phone at 4-6
weeks to provide preliminary estimates of cessation counseling effectiveness for future
studies. The investigators will field test measures, describe the patterns of smoking among
youth, and explore how much receiving interventions affects motivation, quitting,
abstinence/relapse attitudes, attitudes towards internet-based outreach strategies, and
behaviors for 100 smokers.
**we have completed recruitment of providers; we are recruiting teens ONLY at this point**
Status | Completed |
Enrollment | 4100 |
Est. completion date | January 2010 |
Est. primary completion date | October 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 14 Years and older |
Eligibility |
Inclusion Criteria: Practitioner recruitment criteria: - Has a patient flow of several adolescents per week. - Reads and speaks English. - Able and willing to provide informed consent Patient recruitment criteria: - 14 years or older - Lives in a home or apartment with access to a phone or mail address - Speaks English - Cognitively able to respond to survey questions - Cognitively able to give assent and obtain parent/guardian permission or consent Exclusion Criteria: - Providers: already participating in a PROS study |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | University of Rochester | Rochester | New York |
Lead Sponsor | Collaborator |
---|---|
University of Rochester | National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | smoking cessation rates | 4-6 weeks | No | |
Primary | quit attempts | 4-6 weeks | No | |
Primary | provider practice change | 6 months | No |
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