SuicideNCT05400135
Qungasvik (Toolbox): Prevention of Alcohol/Suicide Risk in Alaska Native Youth
A study testing Qungasvik (Tools for Life) in people with Suicide and Alcohol Use Disorder, run by University of Alaska Fairbanks at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Suicide, Alcohol Use Disorder
- What is being tested?
- Qungasvik (Tools for Life)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 542 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2017to Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Alaska Native youth 12-21 years
Who cannot join
- Children under the age of 12
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Alaska Fairbanks
Fairbanks, Alaska, 99775
Stacy Rasmus, PhD, 907-474-7352, smrasmus@alaska.edu
About this study
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
- Being tested
- Qungasvik (Tools for Life)
- Keywords
- Alaska Native, Alcohol, Indigenous, Rural, Suicide, Prevention, Multi-level, Small samples, Dynamic wait-listed design, Stepped wedge design, Protective Factors, Reasons for Life
- Medical subject headings
- Suicide, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qungasvik (Tools for Life)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Qungasvik (Tools for Life) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 1-year, 2-year, 3-year, 4-year
Secondary outcomes (4)
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.
Measured: Baseline, 1-year, 2-year, 3-year, 4-year
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.
Measured: Baseline, 1-year, 2-year, 3-year, 4-year
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.
Measured: Baseline, 1-year, 2-year, 3-year, 4-year
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.
Measured: Baseline, 1-year, 2-year, 3-year, 4-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start16 Mar 2017
- Primary completionMar 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SuicideStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 542 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alaska Fairbanks
- Sponsor type
- University, hospital or other
- Collaborators
- University of Minnesota
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05400135
- Sponsor's protocol ID
- R01AA023754
- Status last verified
- May 2022
- First submitted
- 7 Jan 2022
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qungasvik (Toolbox): Prevention of Alcohol/Suicide Risk in Alaska Native Youth
- ClinicalTrials.gov ID
- NCT05400135
- Acronym / sponsor ID
- R01AA023754
- Conditions
- Suicide, Alcohol Use Disorder
- Keywords
- Alaska Native, Alcohol, Indigenous, Rural, Suicide, Prevention, Multi-level, Small samples
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 542 participants (estimated)
- Lead sponsor
- University of Alaska FairbanksUniversity, hospital or other
- Collaborators
- University of Minnesota
- Study start
- 16 Mar 2017 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 1 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Qungasvik Intervention Group | Experimental | Behavioral: Qungasvik (Tools for Life)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. |
Who may qualify
- Ages
- 12 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Alaska Native youth 12-21 years
Key exclusion criteria (1 listed)
- Children under the age of 12
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Qungasvik Intervention Group |
Primary outcome
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.
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.
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.
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.
4 secondary outcomes
Change in Individual Protective Factors
Time frame: 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
Change in Community Protective Factors
Time frame: Baseline, 1-year, 2-year, 3-year, 4-year
Change in Peer Influences
Time frame: Baseline, 1-year, 2-year, 3-year, 4-year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Qungasvik (Tools for Life) in people with Suicide and Alcohol Use Disorder, run by University of Alaska Fairbanks at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stacy Rasmus, PhD (907-474-7352, smrasmus@alaska.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Reflective Processes (time frame: Baseline, 1-year, 2-year, 3-year, 4-year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2022.