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Qungasvik (Toolbox): Prevention of Alcohol/Suicide Risk in Alaska Native Youth

Primary Purpose

Suicide, Alcohol Use Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Qungasvik (Tools for Life)
Sponsored by
University of Alaska Fairbanks
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Suicide focused on measuring Alaska Native, Alcohol, Indigenous, Rural, Suicide, Prevention, Multi-level, Small samples, Dynamic wait-listed design, Stepped wedge design, Protective Factors, Reasons for Life

Eligibility Criteria

12 Years - 21 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Alaska Native youth 12-21 years

Exclusion Criteria:

  • Children under the age of 12

Sites / Locations

  • University of Alaska FairbanksRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Qungasvik Intervention Group

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
Change in Rollnick's Readiness Ruler
An adaptation of the RRR will provide an analog scale assessment of motivation to remain abstinent.

Secondary Outcome Measures

Change in Individual Protective Factors
(10 items, alpha=.69). This uses the Mastery-Family and Mastery-Friends subscales from the Multicultural Mastery Scale to measure communal mastery, or efficacy in solving life challenges and control through strategies that focus on joining with other significant figures in the social environment.
Change in Family Protective Factors
(19 items, alpha=.69). The Brief Family Relationship Scale includes subscales tapping Cohesion, Expressiveness, and Conflict, and was designed as a culturally appropriate adaptation of the Family Environment Scale relationship dimension.
Change in Community Protective Factors
(7 items, alpha=.62). The Youth Community Protective Factors Scale was adapted from the Yup'ik Protective Factors scale5 to measure elements of protective communities for youth. Its subscales tap Support and Opportunities for youth in their community.
Change in Peer Influences
(10 items, alpha=.96). Peer Influences was adapted for understandability and relevance to rural AN youth from the American Drug and Alcohol Survey which has been used extensively in research with American Indian youth on peer attitudes that discourage alcohol use.

Full Information

First Posted
January 7, 2022
Last Updated
May 26, 2022
Sponsor
University of Alaska Fairbanks
Collaborators
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT05400135
Brief Title
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 16, 2017 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alaska Fairbanks
Collaborators
University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
542 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Qungasvik Intervention Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Qungasvik (Tools for Life)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Reflective Processes
Description
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.
Time Frame
Baseline, 1-year, 2-year, 3-year, 4-year
Title
Change in Reasons for Life
Description
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.
Time Frame
Baseline, 1-year, 2-year, 3-year, 4-year
Title
Change in Alcohol Consequences
Description
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.
Time Frame
Baseline, 1-year, 2-year, 3-year, 4-year
Title
Change in Rollnick's Readiness Ruler
Description
An adaptation of the RRR will provide an analog scale assessment of motivation to remain abstinent.
Time Frame
Baseline, 1-year, 2-year, 3-year, 4-year
Secondary Outcome Measure Information:
Title
Change in Individual Protective Factors
Description
(10 items, alpha=.69). This uses the Mastery-Family and Mastery-Friends subscales from the Multicultural Mastery Scale to measure communal mastery, or efficacy in solving life challenges and control through strategies that focus on joining with other significant figures in the social environment.
Time Frame
Baseline, 1-year, 2-year, 3-year, 4-year
Title
Change in Family Protective Factors
Description
(19 items, alpha=.69). The Brief Family Relationship Scale includes subscales tapping Cohesion, Expressiveness, and Conflict, and was designed as a culturally appropriate adaptation of the Family Environment Scale relationship dimension.
Time Frame
Baseline, 1-year, 2-year, 3-year, 4-year
Title
Change in Community Protective Factors
Description
(7 items, alpha=.62). The Youth Community Protective Factors Scale was adapted from the Yup'ik Protective Factors scale5 to measure elements of protective communities for youth. Its subscales tap Support and Opportunities for youth in their community.
Time Frame
Baseline, 1-year, 2-year, 3-year, 4-year
Title
Change in Peer Influences
Description
(10 items, alpha=.96). Peer Influences was adapted for understandability and relevance to rural AN youth from the American Drug and Alcohol Survey which has been used extensively in research with American Indian youth on peer attitudes that discourage alcohol use.
Time Frame
Baseline, 1-year, 2-year, 3-year, 4-year
Other Pre-specified Outcome Measures:
Title
Change in Social Relationships
Description
This is a measure that examines social network characteristics of supportive relationships with elders, immediate and extended kinship relations, and community adults.
Time Frame
Baseline through end of intervention delivery, an average of 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Alaska Native youth 12-21 years Exclusion Criteria: Children under the age of 12
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stacy Rasmus, PhD
Phone
907-474-7352
Email
smrasmus@alaska.edu
Facility Information:
Facility Name
University of Alaska Fairbanks
City
Fairbanks
State/Province
Alaska
ZIP/Postal Code
99775
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stacy Rasmus, PhD
Phone
907-474-7352
Email
smrasmus@alaska.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
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.

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Qungasvik (Toolbox): Prevention of Alcohol/Suicide Risk in Alaska Native Youth

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