Tobacco Cessation Treatment for Alaska Native Youth
Condition: Tobacco Cessation
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    


Intervention name(s): Written self-help materials; Group behavioral counseling
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Written materials to help adolescents stop tobacco use; group behavioral counseling (2 day weekend program)
Other intervention name(s): Control condition; intervention condition
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment