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NCT01099384 · ClinicalTrials.gov registry record · Phase 1
Tobacco Cessation Treatment for Alaska Native Youth
A Phase 1 study of Tobacco Cessation, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 1
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT01099384: Completed Phase 1 study of Tobacco Cessation, sponsored by Mayo Clinic.
NCT01099384 is a Phase 1 study of Tobacco Cessation that has completed, run by Mayo Clinic. The registered enrollment target is 100 participants, below the 1,657-participant average among 8 other Tobacco Cessation trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01099384, a Phase 1 study of Tobacco Cessation, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
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
Conditions Studied
Interventions
- BEHAVIORAL Written self-help materials
- BEHAVIORAL Group behavioral counseling
Study Locations (1)
Alaska
- Yukon Kuskokwim Health Corporation - Bethel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2010-09 |
| Est. Completion | 2012-07 |
| Phase | Phase 1 |
What the finished NCT01099384 record still lists
NCT01099384 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 1,657-participant average among 8 other Tobacco Cessation trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Tobacco Cessation appearing as the primary indexed condition, and to 2 interventions - of which Written self-help materials is the first listed.
NCT01099384 reports a single indexed study location in Alaska.
Frequently Asked Questions
What is clinical trial NCT01099384 about?
NCT01099384 is a clinical study titled "Tobacco Cessation Treatment for Alaska Native Youth". 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, approximatel...
What is the current status of trial NCT01099384?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2010-09. Estimated completion is 2012-07.
What conditions does trial NCT01099384 study?
This clinical trial studies the following conditions: Tobacco Cessation.
What interventions are being tested in trial NCT01099384?
The interventions under investigation include: Written self-help materials (BEHAVIORAL), Group behavioral counseling (BEHAVIORAL).
Who is sponsoring clinical trial NCT01099384?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01099384 being conducted?
This trial has 1 study location across Alaska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01099384's enrollment target sits among peer trials
100 8th of 8 higher than 1 of 8 other Tobacco Cessation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Tobacco Cessation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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