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

May 26, 2022 updated by: University of Alaska Fairbanks
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
542

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alaska
      • Fairbanks, Alaska, United States, 99775
        • Recruiting
        • University of Alaska Fairbanks

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 years to 17 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Alaska Native youth 12-21 years

Exclusion Criteria:

  • Children under the age of 12

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Qungasvik Intervention Group
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)
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Reflective Processes
Time Frame: Baseline, 1-year, 2-year, 3-year, 4-year
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
Time Frame: Baseline, 1-year, 2-year, 3-year, 4-year
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
Time Frame: Baseline, 1-year, 2-year, 3-year, 4-year
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
Time Frame: Baseline, 1-year, 2-year, 3-year, 4-year
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Individual Protective Factors
Time Frame: Baseline, 1-year, 2-year, 3-year, 4-year
(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.
Baseline, 1-year, 2-year, 3-year, 4-year
Change in Family Protective Factors
Time Frame: Baseline, 1-year, 2-year, 3-year, 4-year
(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.
Baseline, 1-year, 2-year, 3-year, 4-year
Change in Community Protective Factors
Time Frame: Baseline, 1-year, 2-year, 3-year, 4-year
(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.
Baseline, 1-year, 2-year, 3-year, 4-year
Change in Peer Influences
Time Frame: Baseline, 1-year, 2-year, 3-year, 4-year
(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.
Baseline, 1-year, 2-year, 3-year, 4-year

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Social Relationships
Time Frame: Baseline through end of intervention delivery, an average of 2 years
This is a measure that examines social network characteristics of supportive relationships with elders, immediate and extended kinship relations, and community adults.
Baseline through end of intervention delivery, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Alaska Fairbanks

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 16, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 7, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 1, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 1, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R01AA023754 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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