Tobacco Cessation Clinical Trial
Official title:
Tobacco Cessation Treatment for Alaska Native Youth
Tobacco use among adolescents is a major public health problem in the United States. The
prevalence of tobacco use among adolescents is currently highest among American Indians and
Alaska Natives. Among Alaska Natives residing in the Yukon-Kuskokwim (Y-K) Delta region of
western Alaska, approximately 29% of 11-14 year olds, and 63% of 15-18 year olds, use
tobacco. No prior work has evaluated tobacco cessation interventions for Alaska Native
adolescents.
This proposal builds on the investigators successful partnership and 7 year track record of
collaboration with the Y-K Delta Alaska Native community. The objective of this proposal is
to develop and pilot test a novel, culturally-appropriate, behavioral treatment approach for
tobacco cessation among Y-K Delta Alaska Native adolescents ages 12 to 17. The behavioral
intervention will include an initial, 2 day, group-based program with follow-up support for
6 weeks. Social cognitive (learning) theory is the conceptual basis for the proposed
intervention. The investigators expect that as a result of this stage I project, the
investigators will have developed a replicable, feasible, and acceptable intervention, the
efficacy of which can be tested in future large-scale randomized clinical trials.
This project will take place in two phases. In phase 1, the investigators will develop the
intervention with feedback from a teen advisory group, and develop a counselor manual.
Follow-up strategies will also be developed, pilot-tested, and refined. Twenty adolescents
will complete the protocol, which will be refined in an iterative manner based on feedback
from participants and counselors. Phase 2, consisting of a pilot clinical trial, will apply
a group-randomized design with assessments at weeks 0 (baseline), 6, and 26. Eight villages
will be randomized to receive either the behavioral intervention or control condition
(written self-help materials + quitline referral). Ten adolescents will be enrolled from
each village, for a total of 80 participants. The investigators will assess the feasibility
and acceptability of the intervention, as determined by qualitative ratings of treatment
acceptability, and recruitment and retention rates. The investigators will estimate the
magnitude of the effect of the intervention compared to the control condition on the
biochemically confirmed tobacco abstinence rate at weeks 6 and 26, and estimate the
intra-class correlation coefficient (ICC). At week 6, the investigators will evaluate the
effect of the intervention on changes from baseline on perceived social support,
self-efficacy for stopping tobacco use, and other mechanisms of change consistent with the
investigators theoretical framework. The overall health related objective is to develop
effective treatment programs for Alaska Native youth that will ultimately reduce their risk
of tobacco-related disease.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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