NCT05400135

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
542

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 16, 2017

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

January 7, 2022

Completed
5 months until next milestone

First Posted

Study publicly available on registry

June 1, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

June 1, 2022

Status Verified

May 1, 2022

Enrollment Period

6 years

First QC Date

January 7, 2022

Last Update Submit

May 26, 2022

Conditions

Keywords

Alaska NativeAlcoholIndigenousRuralSuicidePreventionMulti-levelSmall samplesDynamic wait-listed designStepped wedge designProtective FactorsReasons for Life

Outcome Measures

Primary Outcomes (4)

  • Change in Reflective Processes

    5 items, item separation reliability=.77. This measure is adapted from the adult Yup'ik Protective Factors scale5, and taps a culturally patterned type of awareness (ellangneq) used in thinking over potential negative consequences of alcohol misuse engaged by Alaska Native youth when considering reasons to not drink.

    Baseline, 1-year, 2-year, 3-year, 4-year

  • Change in Reasons for Life

    5 items, =.78. This measure is an extension of constructs tapped in the Brief Reasons for Living Inventory for Adolescents, itself a modification of an adult measure, the Reasons for Living Inventory. RFL assess beliefs and experiences that make life enjoyable, worthwhile, and provide meaning. Items tap cultural/spiritual beliefs, sense of family responsibility, and others' assessment of the young person. The measure provides a positive psychology approach to assessing AN cultural values associated with protection from suicide.

    Baseline, 1-year, 2-year, 3-year, 4-year

  • Change in Alcohol Consequences

    The five-item CoNcise Inventory of Problems for Alaska Native Adolescents (NIP-AN-A), adaptation of the Adult NIP-AN, taps social, intrapersonal, impulse control, interpersonal and kinship loss. We adapted the Alcohol Quantity/Frequency/Binge Episode Measure (Q-F-BE) for use in rural Alaska. It assesses the quantity and frequency of drinking including binge drinking episodes which are defined as a consumption pattern of greater than four drinks on one occasion.

    Baseline, 1-year, 2-year, 3-year, 4-year

  • Change in Rollnick's Readiness Ruler

    An adaptation of the RRR will provide an analog scale assessment of motivation to remain abstinent.

    Baseline, 1-year, 2-year, 3-year, 4-year

Secondary Outcomes (4)

  • Change in Individual Protective Factors

    Baseline, 1-year, 2-year, 3-year, 4-year

  • Change in Family Protective Factors

    Baseline, 1-year, 2-year, 3-year, 4-year

  • Change in Community Protective Factors

    Baseline, 1-year, 2-year, 3-year, 4-year

  • Change in Peer Influences

    Baseline, 1-year, 2-year, 3-year, 4-year

Other Outcomes (1)

  • Change in Social Relationships

    Baseline through end of intervention delivery, an average of 2 years

Study Arms (1)

Qungasvik Intervention Group

EXPERIMENTAL

Qungasvik implements intervention modules creating episodes of Yup'ik cultural engagement. In traditional Yup'ik practices prior to formal western schooling, the education and training of young people included introduction to cultural protocols, knowledge, and values while learning skills through participation in daily activities of family and community life such as subsistence, tool-building, and ceremony (Rasmus, Charles, \& Mohatt, 2014). The intervention manual provides outlines for 18 modules described as teachings, and conducted at the individual, family, or community level through one or more 1-3 hour sessions. Each module promotes 2-4 of a total of 13 protective factors.

Behavioral: Qungasvik (Tools for Life)

Interventions

The Qungasvik (toolbox) intervention is designed to build protection against alcohol use disorder (AUD) and suicide in Yup'ik Alaska Native youth 12-18 years old. The intervention is a community-driven and culturally-based process that develops and delivers 18-24 prevention activities leading to the two primary prevention variables, Reasons for Life and Reflective Processes about the Consequences of Alcohol Use and secondary prevention variables of multi-level protective factors and social networks.

Qungasvik Intervention Group

Eligibility Criteria

Age12 Years - 21 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Alaska Native youth 12-21 years

You may not qualify if:

  • Children under the age of 12

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alaska Fairbanks

Fairbanks, Alaska, 99775, United States

RECRUITING

MeSH Terms

Conditions

SuicideAlcoholism

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehaviorAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Central Study Contacts

Stacy Rasmus, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2022

First Posted

June 1, 2022

Study Start

March 16, 2017

Primary Completion

March 1, 2023

Study Completion

March 1, 2023

Last Updated

June 1, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Pursuant to Title 45 CFR 46, American Indian and Alaska Native Tribes have the authority to make the decisions and set policy in the protection of human subjects involved in research taking place with members of federally-recognized Tribes. All potential participants in the awarded application are members of federally-recognized Tribes, and each partnering Tribal organization, has passed a formal Resolution or equivalent Tribal law that delegates the ruling body's authority to each of their respective research review boards. The Tribal research review boards will issue binding findings about the proposed research study to include data sharing, ownership and management.

Locations