Recruiting

Qungasvik

Sponsor:

University of Alaska Fairbanks

Code:

NCT05400135

Conditions

Suicide

Alcohol Use Disorder

Eligibility Criteria

Sex: All

Age: 12 - 21

Healthy Volunteers: Accepted

Interventions

Qungasvik (Tools for Life)

Study Details

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.

Conditions

Suicide

Alcohol Use Disorder

Study ID

NCT05400135

Start date

Mar 16, 2017

Status verified date

May, 2022

Completion date

Mar, 2023

Anticipated

Primary completion date

Mar, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 21

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Alaska Native youth 12-21 years

Exclusion Criteria:

  • Children under the age of 12

Study Design

Enrollment

542 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Change in Reflective Processes [ Time Frame: 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 ]
  • Change in Alcohol Consequences [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

Stacy Rasmus, PhD

907-474-7352smrasmus@alaska.edu

Locations

University of Alaska Fairbanks

Recruiting

Fairbanks, Alaska, United States, 99775

Contacts

Stacy Rasmus, PhD

907-474-7352smrasmus@alaska.edu

More Information

Sponsor

University of Alaska Fairbanks

Last update posted

Jun 1, 2022

Last verified

May, 2022

Keywords

  • Alaska Native
  • Alcohol
  • Indigenous
  • Rural
  • Suicide
  • Prevention
  • Multi-level
  • Small samples
  • Dynamic wait-listed design
  • Stepped wedge design
  • Protective Factors
  • Reasons for Life

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alaska Fairbanks on 2022-06-01.