Smoking Cessation Clinical Trial
Official title:
Proactive Smoking Cessation for Adolescents
The primary goal of the Hutchinson Study of High School Smoking, a group-randomized trial conducted by the Fred Hutchinson Cancer Research Center in partnership with 50 Washington State high schools, is to develop and evaluate an innovative proactive smoking cessation intervention, based upon Motivational Interviewing (MI) and Cognitive Behavioral Skills Training (CBST), for its effectiveness in reaching teen smokers and helping them succeed in quitting smoking. A positive finding would have significant implications for reducing youth smoking and, ultimately, improving the nation's health.
Rates of smoking prevalence among US adolescents remain unacceptably high, with 24% of high
school seniors smoking monthly and 16% smoking daily. Unfortunately, without intervention,
for the majority of these adolescent smokers, smoking will be a long-term addiction. Recent
studies have demonstrated that a majority of teen smokers want to quit and try to do so, but
with little success.
The Hutchinson Study of High School Smoking is a 2-arm group-randomized trial in adolescent
smoking cessation, conducted by the Fred Hutchinson Cancer Research Center in partnership
with 50 Washington State high schools. Twenty-five high schools are randomly assigned to the
experimental (intervention) condition and 25 are assigned to the control (no intervention)
condition. The trial uses innovative and rigorous trial design and methodology to address
recruitment, retention, and other methodological challenges encountered in early adolescent
cessation trials, to provide a rigorous test of in innovative proactive smoking cessation
intervention. Participants are 2,151 high school students (all smokers and a sample of
nonsmokers identified via baseline survey of all enrolled students at the end of their
junior year).
The intervention, delivered during the senior year of high school, consists of a series of
counselor-initiated, individually-tailored telephone counseling calls. Incorporating both
Motivational Interviewing and Cognitive Behavioral skills training, the counseling telephone
calls aim to increase smokers' motivation for quitting smoking, build skills for smoking
cessation, and assist with relapse prevention. For nonsmokers, the telephone calls provide
positive reinforcement of students' abstinence choices and help build skills for supporting
peers' efforts to quit smoking. Complementary intervention components include an interactive
cessation/informational Web site (www.Matchbreaker.org) and school-based promotional
materials (cessation posters, school newspaper ads).
Participants are followed to two follow-up times: the first at age 19 (approximately 6
months post-high school), and the second at age 25, to assess immediately after high school,
and again in young adulthood, the intervention's impact on cessation status, number of quit
attempts, change in readiness to quit and reduction in frequency and level of smoking.
Concerning effectiveness in reaching teen smokers, 65.3% (691 out of 1058) smokers in the
intervention condition were successfully recruited, and participated in the telephone
counseling.
Concerning effectiveness in helping teen smokers quit smoking, at the first follow-up, the
intervention increased the percentage who achieved 6-month prolonged smoking abstinence
among all smokers (21.8% in the experimental condition vs 17.7% in the control condition,
difference = 4.0%, 95% confidence interval [CI] = −0.2 to 8.1, P = .06) and in particular
among daily smokers (10.1% vs 5.9%, difference = 4.1%, 95% CI = 0.8 to 7.1, P = .02). There
was also generally strong evidence of intervention impact for 3-month, 1-month, and 7-day
abstinence and duration since last cigarette (P = .09, .015, .01, and .03, respectively).
The intervention effect was strongest among male daily smokers and among female
less-than-daily smokers.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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