Clinical trial NCT05400135: Qungasvik (Toolbox): Prevention of Alcohol/Suicide Risk in Alaska Native Youth
Official title: Qungasvik (Toolbox): Prevention of Alcohol/Suicide Risk in Alaska Native Youth
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Suicide
Alcohol Use Disorder
Keywords: Alaska Native
Alcohol
Indigenous
Rural
Suicide
Prevention
Multi-level
Small samples
Dynamic wait-listed design
Stepped wedge design
Protective Factors
Reasons for Life
Lead sponsor: University of Alaska Fairbanks
Sponsor class: OTHER
Collaborators: name: University of Minnesota
First posted: 2022-06-01
Enrollment: 542
Sex: ALL
Minimum age (years): 12
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study utilizes a hybrid design with a two group community level four year interrupted time series design with an embedded five group community level dynamic wait-listed design. Youth participants (12-18 years) in each community are assigned to a single treatment group.
Primary purpose: PREVENTION

Brief summary: For the past 20+ years the investigators have focused on addressing two interrelated public health issues, alcohol use disorder (AUD) and suicide in Alaska. There is no greater source of health disparity in American Indian and Alaska Native (AI/AN) communities than that involving AUD and suicide, and no greater necessity in addressing this disparity than the development of sustained, trusting, collaborative, and non-exploitive research relationships with those who historically experienced forced acculturation and exploitation. Yup'ik community leaders have made addressing AUD and suicide among their highest priorities. Working with Yup'ik community members, the investigators developed a multilevel (individual, family, peer, and community) intervention that uses a culturally-based AUD and suicide prevention framework. The Qungasvik (kung-az-vik; a Yup'ik word meaning 'toolbox') intervention is a Yup'ik AN approach to prevention organized and implemented utilizing a local indigenous theory of change and process model to build protective factors against AUD and suicide. The purposes of the proposed research are to: (a) validate results obtained from previous smaller intervention studies aimed at reducing the incidence of AUD and suicide in 12-18 year old Yup'ik Alaska Native (AN) youth; and (b) learn more about the relative importance of the individual, family, peer, and community variables that underscore the Qungasvik intervention. This study will: (a) assess the efficacy of the Qungasvik intervention through a two group community level trial using an interrupted time series design with wait-listed control, and (b) examine mechanisms of change in response to intervention. Specific aims (SA) of the project are to: (SA1) test the Qungasvik intervention efficacy through impact on the ultimate outcome variables of reasons for life and reflective processes on alcohol use consequences, and on suicidal ideation and alcohol use; (SA2) examine the mechanisms of change in response to the Qungasvik intervention through (a) self-report outcome measures of protective factors (b) social network assessment and (c) process evaluation; (SA3) test levels of fidelity of the implementation of the intervention with regard to the Yup'ik indigenous theory-driven intervention model outlined in the Qungasvik manual of operations.


Eligibility criteria: Inclusion Criteria:

* Alaska Native youth 12-21 years

Exclusion Criteria:

* Children under the age of 12

Primary outcomes:
measure: Change in Reflective Processes
timeFrame: Baseline, 1-year, 2-year, 3-year, 4-year
measure: Change in Reasons for Life
timeFrame: Baseline, 1-year, 2-year, 3-year, 4-year
measure: Change in Alcohol Consequences
timeFrame: Baseline, 1-year, 2-year, 3-year, 4-year
measure: Change in Rollnick's Readiness Ruler
timeFrame: Baseline, 1-year, 2-year, 3-year, 4-year
Secondary outcomes:
measure: Change in Individual Protective Factors
timeFrame: Baseline, 1-year, 2-year, 3-year, 4-year
measure: Change in Family Protective Factors
timeFrame: Baseline, 1-year, 2-year, 3-year, 4-year
measure: Change in Community Protective Factors
timeFrame: Baseline, 1-year, 2-year, 3-year, 4-year
measure: Change in Peer Influences
timeFrame: Baseline, 1-year, 2-year, 3-year, 4-year
Other outcomes:
measure: Change in Social Relationships
timeFrame: Baseline through end of intervention delivery, an average of 2 years
Locations:
city: Fairbanks
country: United States
facility: University of Alaska Fairbanks
state: Alaska
Study officials:
References: