Tobacco Cessation Treatment for Alaska Native Youth

NCT01099384 | Completed Phase 1 DMC

• 2 other identifiers: 09-003981R01DA025156
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tobacco Cessation

Outcome Measures

Primary Outcomes (1)

• Feasibility of recruitment

  Assessed at the time of screening

Secondary Outcomes (2)

• Biochemically confirmed tobacco abstinence

  Assessed at Week 6 (End of Treatment)

• Study retention

  Assessed at week 24

Study Arms (2)

Behavioral: written self-help materials

ACTIVE COMPARATOR

Behavioral: written self-help materials

Behavioral: Written self-help materials

Group behavioral counseling

EXPERIMENTAL

Group behavioral counseling, weekend program

Behavioral: Group behavioral counseling

Interventions

Written self-help materials BEHAVIORAL

Written materials to help adolescents stop tobacco use

Also known as: Control condition

Behavioral: written self-help materials

Group behavioral counseling BEHAVIORAL

group behavioral counseling (2 day weekend program)

Also known as: intervention condition

Group behavioral counseling

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Alaska Native
• is from one of the targeted villages
• is between 12-17 years of age
• provides written assent
• provides written parental consent
• 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
• is willing to make a quit attempt
• is willing and able to participate in all aspects of the study
• has access to Web/e-mail and a working telephone.

You may not qualify if:

• 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)
• depression score of \>16 as assessed by the Center for Epidemiological Studies Depression Scale (CES-D; Radloff, 1977)
• current (past 3 months) participation in any tobacco pharmacological or behavioral treatment
• another adolescent from the same household has enrolled.

Sponsors & Collaborators

• Mayo Clinic: lead
• Yukon Kuskokwim Health Corporation: collaborator

Study Sites (1)

Yukon Kuskokwim Health Corporation

Bethel, Alaska, 99559, United States

Location

MeSH Terms

Conditions

Tobacco Use Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology

Study Record Dates

• First Submitted: April 2, 2010
• First Posted: April 7, 2010
• Study Start: September 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: May 23, 2013

Record last verified: 2013-05

Locations

US (1)