Tobacco Cessation Treatment for Alaska Native Youth

NCT ID: NCT01099384

Last Updated: 2013-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2012-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Behavioral: written self-help materials

Behavioral: written self-help materials

Group Type: ACTIVE_COMPARATOR

Written self-help materials

Intervention Type: BEHAVIORAL

Written materials to help adolescents stop tobacco use

Group behavioral counseling

Group behavioral counseling, weekend program

Group Type: EXPERIMENTAL

Group behavioral counseling

Intervention Type: BEHAVIORAL

group behavioral counseling (2 day weekend program)

Interventions

Written self-help materials

Written materials to help adolescents stop tobacco use

Intervention Type: BEHAVIORAL

Group behavioral counseling

group behavioral counseling (2 day weekend program)

Intervention Type: BEHAVIORAL

Other Intervention Names

Control condition; intervention condition

Eligibility 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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yukon Kuskokwim Health Corporation

OTHER

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Christi Patten

Professor of Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Yukon Kuskokwim Health Corporation

Bethel, Alaska, United States

Countries

United States

Other Identifiers

R01DA025156

Identifier Type: NIH

Identifier Source: secondary_id

View Link

09-003981

Identifier Type: -

Identifier Source: org_study_id