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
  Purpose

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.


Condition Intervention Phase
Tobacco Cessation
Behavioral: Written self-help materials
Behavioral: Group behavioral counseling
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Tobacco Cessation Treatment for Alaska Native Youth

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Feasibility of recruitment [ Time Frame: Assessed at the time of screening ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 100
Study Start Date: September 2010
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Behavioral: written self-help materials
Behavioral: written self-help materials
Behavioral: Written self-help materials
Written materials to help adolescents stop tobacco use
Other Name: Control condition
Experimental: Group behavioral counseling
Group behavioral counseling, weekend program
Behavioral: Group behavioral counseling
group behavioral counseling (2 day weekend program)
Other Name: intervention condition

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01099384

Locations
United States, Alaska
Yukon Kuskokwim Health Corporation
Bethel, Alaska, United States, 99559
Sponsors and Collaborators
Mayo Clinic
Yukon Kuskokwim Health Corporation
  More Information

No publications provided

Responsible Party: Christi Patten, Professor of Psychology, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01099384     History of Changes
Other Study ID Numbers: 09-003981, R01 DA25156
Study First Received: April 2, 2010
Last Updated: May 21, 2013
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on September 16, 2014