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Tobacco Cessation Treatment for Alaska Native Youth

This study has been completed.
Sponsor:
Collaborator:
Yukon Kuskokwim Health Corporation
Information provided by (Responsible Party):
Christi Patten, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01099384
First received: April 2, 2010
Last updated: May 21, 2013
Last verified: May 2013

April 2, 2010
May 21, 2013
September 2010
July 2012   (final data collection date for primary outcome measure)
Feasibility of recruitment [ Time Frame: Assessed at the time of screening ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01099384 on ClinicalTrials.gov Archive Site
  • Biochemically confirmed tobacco abstinence [ Time Frame: Assessed at Week 6 (End of Treatment) ] [ Designated as safety issue: No ]
  • Study retention [ Time Frame: Assessed at week 24 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Tobacco Cessation Treatment for Alaska Native Youth
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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Tobacco Cessation
  • Behavioral: Written self-help materials
    Written materials to help adolescents stop tobacco use
    Other Name: Control condition
  • Behavioral: Group behavioral counseling
    group behavioral counseling (2 day weekend program)
    Other Name: intervention condition
  • Active Comparator: Behavioral: written self-help materials
    Behavioral: written self-help materials
    Intervention: Behavioral: Written self-help materials
  • Experimental: Group behavioral counseling
    Group behavioral counseling, weekend program
    Intervention: Behavioral: Group behavioral counseling
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
July 2012
July 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Alaska Native
  2. is from one of the targeted villages
  3. is between 12-17 years of age
  4. provides written assent
  5. provides written parental consent
  6. self-reports daily use of Iqmik, commercial ST, and/or cigarette smoking during the past 7 days, with current tobacco use status verified with a NicAlert salivary cotinine test strip value of >0
  7. is willing to make a quit attempt
  8. is willing and able to participate in all aspects of the study
  9. has access to Web/e-mail and a working telephone.

Exclusion Criteria:

  1. the adolescent is not able to fully participate in the intervention or would potentially pose harm to self or other group participants, and/or disrupt the group process (e.g., if subject is intoxicated at screening)
  2. depression score of >16 as assessed by the Center for Epidemiological Studies Depression Scale (CES-D; Radloff, 1977)
  3. current (past 3 months) participation in any tobacco pharmacological or behavioral treatment
  4. another adolescent from the same household has enrolled.
Both
12 Years to 17 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01099384
09-003981, R01 DA25156
Yes
Christi Patten, Mayo Clinic
Mayo Clinic
Yukon Kuskokwim Health Corporation
Not Provided
Mayo Clinic
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP