Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01099384
Study type Interventional
Source Mayo Clinic
Contact
Status Completed
Phase Phase 1
Start date September 2010
Completion date July 2012

See also
  Status Clinical Trial Phase
Enrolling by invitation NCT05415371 - Persistent Poverty Counties Pregnant Women With Medicaid N/A
Not yet recruiting NCT04501016 - A Stepped Care Approach to Treating Tobacco Use in Rural Veterans Phase 2/Phase 3
Completed NCT01651611 - Intervention Study to Increase Smoking Cessation Rates Among Public Housing Residents N/A
Completed NCT01570595 - Positively Smoke Free on the Web (PSFW) for Smokers Living With HIV Phase 1/Phase 2
Completed NCT01164306 - The Impact of a Tobacco Control Intervention in African-American Families N/A
Recruiting NCT04865276 - Adaptation and Evaluation of a Culturally and Gender Relevant Tobacco Cessation Among Women in Brazil: An Integrated mHealth Approach N/A
Recruiting NCT02103868 - Medium Vs Low Intensity Intervention in Tobacco Cessation and Control in Zari Workers N/A
Completed NCT00836199 - NicVAX/Placebo as an Aid for Smoking Cessation Phase 3
Recruiting NCT05552534 - Impact of an Intervention of Screening, Treatment Initiation and Referral to PROmote Smoking CEssation in Emergency Department Patients N/A
Completed NCT01482923 - Tobacco Assessment and Intervention With Low-Income Persons Living With HIV-AIDS (PLWHA) in Community-Based AIDS Service Organizations
Completed NCT05764343 - The Effect of Immediate Smoking Cessation Interventions for Smokers With Chronic Airway Diseases N/A
Completed NCT03377738 - Effectiveness of the Spirometry Test as a Motivational Tool for Quitting Tobacco in Primary Care N/A
Completed NCT01312480 - Adolescent Smoking Cessation in Pediatric Primary Care N/A
Completed NCT03096145 - Support Person Intervention to Promote a Smoking Helpline Among Under Resourced Smokers N/A
Completed NCT05095779 - Incentives for Smoking Cessation in Persistent Poverty Counties N/A
Completed NCT03062709 - A Study of Tobacco Smoke and Children With Respiratory Illnesses N/A
Completed NCT00750503 - Workplace Tobacco Cessation And Oral Cancer Screening Study Phase 3
Withdrawn NCT04340102 - Development of a Scalable Intervention to Improve Smoking Cessation in Persons With Serious Mental Illness N/A
Completed NCT01331226 - Support Person Intervention to Promote a Smoking Helpline N/A
Completed NCT04198688 - Effectiveness of Intensive Smoking Cessation Interventions in Patients With Cancer