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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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Two interventions will be delivered virtually to American Indian/Alaska Native youth who have been hospitalized with suicidal attempt, suicidal ideation, or associated risk behaviors, including alcohol-related injury.
The investigators will conduct a randomized controlled trial whereby Alaska Native (AN) youth who are hospitalized for suicide risk will be randomly assigned to either Qungasvik/Tools for Life or Tools for Life + Motivational Interviewing Social Network (MISN) intervention after their baseline survey, and followed up at 3-, 6-, and 12 months. All youth will receive Tools for Life and two 30-minute virtual follow-up visits (at 2- and 6-weeks post intervention) focused on connectivity to culture and obtaining support from intergenerational social networks in their home communities. Half of the youth will also receive MISN in addition to Tools for Life. Both interventions will be delivered virtually by a wellness team comprised of Alaska Native community behavioral health aides, prevention specialists and/or Elders who function in their communities as natural healers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tools for Life | Active Comparator | All youth will receive the Tools for Life (Qungasvik) intervention. Tools for Life is an evidence-based, community-developed intervention focused on providing protective cultural experiences for Alaska Native youth to address suicide risk and alcohol use. |
|
| Tools for Life + Motivational Interviewing Social Network intervention (MISN) | Active Comparator | Half of the youth will will also receive MISN in addition to the Tools for Life intervention. MISN is an evidence-based treatment that augments motivational interviewing with personal social network composition and structure visualization as a means to cultivating healthy social networks and cultural worlds. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tools for Life | Behavioral | Tools for Life focuses on empowering youth to learn more about their culture and their identity. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Suicide intent/risk | We will use the Suicidal Ideation Attributes Scale (SIDAS) [0 = Never, 10 = Always] | Change from baseline to 3 months |
| Suicide intent/risk | We will use the Suicidal Ideation Attributes Scale (SIDAS) [0 = Never, 10 = Always] | Change from baseline to 6 months |
| Suicide intent/risk | We will use the Suicidal Ideation Attributes Scale (SIDAS) [0 = Never, 10 = Always] | Change from baseline to 12 months |
| Depression | Patient Health Questionnaire (PHQ-9) [0 -not at all to 3-nearly every day] | Change from baseline to 3 months |
| Depression | Patient Health Questionnaire (PHQ-9) [0 -not at all to 3-nearly every day] | Change from baseline to 6 months |
| Depression | Patient Health Questionnaire (PHQ-9) [0 -not at all to 3-nearly every day] | Change from baseline to 12 months |
| Anxiety | Generalized Anxiety Disorder scale (GAD-7) [0 -not at all to 3-nearly every day] | Change from baseline to 3 months |
| Anxiety | Generalized Anxiety Disorder scale (GAD-7) [0 -not at all to 3-nearly every day] |
| Measure | Description | Time Frame |
|---|---|---|
| Sobriety self-efficacy | Three items ask how sure youth are about staying sober from alcohol from 1= def drink to 5 = def not drink | Change from baseline to 3 months |
| Sobriety self-efficacy | Three items ask how sure youth are about staying sober from alcohol from 1= def drink to 5 = def not drink |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yukon-Kuskokwim Health Corporation | Bethel | Alaska | 99559 | United States | ||
| Tanana Chiefs Conference |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41094443 | Derived | Rasmus S, D'Amico EJ, Allen J, Nation C, John S, Joseph V, Rodriguez A, Alvarado G, Gittens AD, Palimaru AI, Brown RA, Kennedy DP, Woodward MJ, Parker J, McDonald K. A protocol for a randomized controlled comparative effectiveness trial of two brief interventions focused on social and cultural connectedness to reduce risk for suicide and substance misuse in young Alaska Native people. BMC Public Health. 2025 Oct 15;25(1):3503. doi: 10.1186/s12889-025-24710-z. | |
| 38343833 |
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The investigators will share only deidentified, aggregate data.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 4, 2022 | Jul 29, 2025 | Prot_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 28, 2025 | May 28, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D013406 | Suicide, Attempted |
| D059020 | Suicidal Ideation |
| D000435 | Alcoholic Intoxication |
| D013405 | Suicide |
| ID | Term |
|---|---|
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D019973 | Alcohol-Related Disorders |
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Half of the participants will be randomly assigned to Tools for Life, and the other half will receive Tools for Life plus a Motivational Interviewing Social Network intervention (MISN) and two booster sessions approximately 2 and 6 weeks post-intervention.
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| Tools for Life + MISN | Behavioral | Tools for Life focuses on empowering youth to learn more about their culture and their identity. MISN focuses on helping youth get support from their community and social networks. |
|
| Change from baseline to 6 months |
| Anxiety | Generalized Anxiety Disorder scale (GAD-7) [0 -not at all to 3-nearly every day] | Change from baseline to 12 months |
| Frequency of alcohol use | Number of days used in the past 30 days. [ 0 to 30] | Change from baseline to 3 months |
| Frequency of alcohol use | Number of days used in the past 30 days [ 0 to 30] | Change from baseline to 6 months |
| Frequency of alcohol use | Number of days used in the past 30 days [ 0 to 30] | Change from baseline to 12 months |
| Alcohol use consequences | Number of times in the past 3 months youth experience 4 different alcohol consequences [0 = Never to 6 = 20 or more times] | Change from baseline to 3 months |
| Alcohol use consequences | Number of times in the past 3 months youth experience 4 different alcohol consequences [0 = Never to 6 = 20 or more times] | Change from baseline to 6 months |
| Alcohol use consequences | Number of times in the past 3 months youth experience 4 different alcohol consequences [0 = Never to 6 = 20 or more times] | Change from baseline to 12 months |
| Change from baseline to 6 months |
| Sobriety self-efficacy | Three items ask how sure youth are about staying sober from alcohol from 1= def drink to 5 = def not drink | Change from baseline to 12 months |
| Intentions to be sober from alcohol | Youth report on intentions to be sober in the next 6 months from 1 = def yes to 4 = def no | Change from baseline to 3 months |
| Intentions to be sober from alcohol | Youth report on intentions to be sober in the next 6 months from 1 = def yes to 4 = def no | Change from baseline to 6 months |
| Intentions to be sober from alcohol | Youth report on intentions to be sober in the next 6 months from 1 = def yes to 4 = def no | Change from baseline to 12 months |
| Social network composition | Participants will be asked to name 15 contacts ("alters") who are at least 18 years of age. Participants will rate each of the 15 people on the same set of questions with categorical response options (about demographics, relationship quality, likelihood to use drugs, etc.). For each participant, the selected responses will be summed across all of the network alters and divided by 15 to produce network composition percentages of the whole set of alters named by the participant (% of AI/ANs, % who engage in heavy drinking). | Change from baseline to 3 months |
| Social network composition | Participants will be asked to name 15 contacts ("alters") who are at least 18 years of age. Participants will rate each of the 15 people on the same set of questions with categorical response options (about demographics, relationship quality, likelihood to use drugs, etc.). For each participant, the selected responses will be summed across all of the network alters and divided by 15 to produce network composition percentages of the whole set of alters named by the participant (% of AI/ANs, % who engage in heavy drinking). | Change from baseline to 6 months |
| Social network composition | Participants will be asked to name 15 contacts ("alters") who are at least 18 years of age. Participants will rate each of the 15 people on the same set of questions with categorical response options (about demographics, relationship quality, likelihood to use drugs, etc.). For each participant, the selected responses will be summed across all of the network alters and divided by 15 to produce network composition percentages of the whole set of alters named by the participant (% of AI/ANs, % who engage in heavy drinking). | Change from baseline to 12 months |
| Social network structure | Participants will rate the relationship strength between each of the 15 named alters. For each alter pair participants will rate if the two people know each other and, if yes, have individuals connected recently. Measures of network structure (i.e., network "connectedness") will be constructed from the set of evaluations for each participant. For example, network "density" will be constructed for the network overall, which is calculated by summing the number of alter pairs who know each other and dividing by the total number of possible ties among 15 alters (105). Individual alter "centrality" will be calculated by summing the number of connections each individual alter has with other alters in the network. | Change from baseline to 3 months |
| Social network structure | Participants will rate the relationship strength between each of the 15 named alters. For each alter pair participants will rate if the two people know each other and, if yes, have individuals connected recently. Measures of network structure (i.e., network "connectedness") will be constructed from the set of evaluations for each participant. For example, network "density" will be constructed for the network overall, which is calculated by summing the number of alter pairs who know each other and dividing by the total number of possible ties among 15 alters (105). Individual alter "centrality" will be calculated by summing the number of connections each individual alter has with other alters in the network. | Change from baseline to 6 months |
| Social network structure | Participants will rate the relationship strength between each of the 15 named alters. For each alter pair participants will rate if the two people know each other and, if yes, have individuals connected recently. Measures of network structure (i.e., network "connectedness") will be constructed from the set of evaluations for each participant. For example, network "density" will be constructed for the network overall, which is calculated by summing the number of alter pairs who know each other and dividing by the total number of possible ties among 15 alters (105). Individual alter "centrality" will be calculated by summing the number of connections each individual alter has with other alters in the network. | Change from baseline to 12 months |
| Time spent around peers who use alcohol | Participants will report on how much time is spent around peers who drink from 0 = never to 3 = often | Change from baseline to 3 months |
| Time spent around peers who use alcohol | Participants will report on how much time is spent around peers who drink from 0 = never to 3 = often | Change from baseline to 6 months |
| Time spent around peers who use alcohol | Participants will report on how much time is spent around peers who drink from 0 = never to 3 = often | Change from baseline to 12 months |
| Awareness of connectedness | Youth report on feelings of connectedness to community, family and environment from 1 = strongly agree to 5 strongly disagree | Change from baseline to 3 months |
| Awareness of connectedness | Youth report on feelings of connectedness to community, family and environment from 1 = strongly agree to 5 strongly disagree | Change from baseline to 6 months |
| Awareness of connectedness | Youth report on feelings of connectedness to community, family and environment from 1 = strongly agree to 5 strongly disagree | Change from baseline to 12 months |
| Community protective factors | Youth Community Protective Factors Scale. Youth report on feelings about different protective factors from 1 = strongly agree to 5 strongly disagree | Change from baseline to 3 months |
| Community protective factors | Youth Community Protective Factors Scale Youth report on feelings about different community protective factors from 1 = strongly agree to 5 strongly disagree | Change from baseline to 6 months |
| Community protective factors | Youth Community Protective Factors Scale Youth report on feelings about different community protective factors from 1 = strongly agree to 5 strongly disagree | Change from baseline to 12 months |
| Individual protective factors | Youth report on feelings about different individual protective factors from 1 = strongly agree to 5 strongly disagree | Change from baseline to 3 months |
| Individual protective factors | Youth report on feelings about different individual protective factors from 1 = strongly agree to 5 strongly disagree | Change from baseline to 6 months |
| Individual protective factors | Youth report on feelings about different individual protective factors from 1 = strongly agree to 5 strongly disagree | Change from baseline to 12 months |
| Reasons for life | Brief Reasons for Life Scale from 1 not at all important to 5 very important | Change from baseline to 3 months |
| Reasons for life | Brief Reasons for Life Scale from 1 not at all important to 5 very important | Change from baseline to 6 months |
| Reasons for life | Brief Reasons for Life Scale from 1 not at all important to 5 very important | Change from baseline to 12 months |
| Reflective processes | The Reflective Processes scale taps a culturally patterned type of awareness and youth report from from 1 = strongly agree to 5 strongly disagree | Change from baseline to 3 months |
| Reflective processes | The Reflective Processes scale taps a culturally patterned type of awareness and youth report from from 1 = strongly agree to 5 strongly disagree | Change from baseline to 6 months |
| Reflective processes | The Reflective Processes scale taps a culturally patterned type of awareness and youth report from from 1 = strongly agree to 5 strongly disagree | Change from baseline to 12 months |
| Fairbanks |
| Alaska |
| 99559 |
| United States |
| Derived |
| Rasmus S, D'Amico EJ, Allen J, Nation C, John S, Joseph V, Rodriguez A, Alvarado G, Gittens AD, Palimaru AI, Brown RA, Kennedy DP, Woodward MJ, Parker J, McDonald K. Because We Love You (BeWeL): A protocol for a randomized controlled trial of two brief interventions focused on social and cultural connectedness to reduce risk for suicide and substance misuse in young Alaska Native people. Res Sq [Preprint]. 2024 Jan 22:rs.3.rs-3874293. doi: 10.21203/rs.3.rs-3874293/v1. |
| D019966 |
| Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |