CClinicalTrials.gg
CompletedNCT01099384Updated May 23, 2013

Tobacco Cessation Treatment for Alaska Native Youth

A Phase 1 interventional study of Written self-help materials and Group behavioral counseling in Tobacco Cessation, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 12 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-05-23.

Sponsored by Mayo Clinic · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
12 Years to 17 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Tobacco Cessation
03

In context

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • Active comparator
    Behavioral: written self-help materials

    Behavioral: written self-help materials

    Behavioral: Written self-help materials

  • Experimental
    Group behavioral counseling

    Group behavioral counseling, weekend program

    Behavioral: Group behavioral counseling

Interventions

  • BehavioralWritten self-help materials

    Written materials to help adolescents stop tobacco use

    Also known as: Control condition

  • BehavioralGroup behavioral counseling

    group behavioral counseling (2 day weekend program)

    Also known as: intervention condition

06

What researchers measure

Primary outcomes

  1. Feasibility of recruitment

    Time frame: Assessed at the time of screening

Secondary outcomes

  1. Biochemically confirmed tobacco abstinence

    Time frame: Assessed at Week 6 (End of Treatment)

  2. Study retention

    Time frame: Assessed at week 24

07

Study locations

1 site
  • Yukon Kuskokwim Health Corporation
    Bethel, Alaska 99559, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 23, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01099384
Lead sponsor
Mayo Clinic
Collaborators
Yukon Kuskokwim Health Corporation
Responsible party
Christi Patten (Professor of Psychology, Mayo Clinic) — Principal investigator
First posted
Apr 7, 2010
Start date
Sep 2010
Primary completion
Jul 2012
Completion
Jul 2012
Last update
May 23, 2013

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.

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