BeWel: Suicide Intervention for Alaska Native Youth

Sponsor
RAND (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05360888
Collaborator
Patient-Centered Outcomes Research Institute (Other)
370
2
2
44
185
4.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Tools for Life
  • Behavioral: Tools for Life + MISN
N/A

Detailed Description

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. Half of the youth will also receive MISN in addition to Tools for Life, along with two 30-minute virtual booster sessions (at 2- and 6-weeks post intervention) focused on connectivity to culture and obtaining support from intergenerational social networks in their home communities. 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
370 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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.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.
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Comparative Effectiveness of Two Culturally-Centered Suicide Interventions for Alaska Native Youth
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Mar 1, 2026
Anticipated Study Completion Date :
May 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Tools for Life

All youth will receive the Tools for Life or 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.

Behavioral: Tools for Life
Tools for Life focuses on empowering youth to learn more about their culture and their identity.

Active Comparator: Tools for Life + Motivational Interviewing Social Network intervention (MISN)

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.

Behavioral: Tools for Life + MISN
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.

Outcome Measures

Primary Outcome Measures

  1. Suicide intent/risk [Change from baseline to 3 months]

    We will use the Suicidal Ideation Attributes Scale (SIDAS) [0 = Never, 10 = Always]

  2. Suicide intent/risk [Change from baseline to 6 months]

    We will use the Suicidal Ideation Attributes Scale (SIDAS) [0 = Never, 10 = Always]

  3. Suicide intent/risk [Change from baseline to 12 months]

    We will use the Suicidal Ideation Attributes Scale (SIDAS) [0 = Never, 10 = Always]

  4. Depression [Change from baseline to 3 months]

    Patient Health Questionnaire (PHQ-9) [0 -not at all to 3-nearly every day]

  5. Depression [Change from baseline to 6 months]

    Patient Health Questionnaire (PHQ-9) [0 -not at all to 3-nearly every day]

  6. Depression [Change from baseline to 12 months]

    Patient Health Questionnaire (PHQ-9) [0 -not at all to 3-nearly every day]

  7. Anxiety [Change from baseline to 3 months]

    Generalized Anxiety Disorder scale (GAD-7) [0 -not at all to 3-nearly every day]

  8. Anxiety [Change from baseline to 6 months]

    Generalized Anxiety Disorder scale (GAD-7) [0 -not at all to 3-nearly every day]

  9. Anxiety [Change from baseline to 12 months]

    Generalized Anxiety Disorder scale (GAD-7) [0 -not at all to 3-nearly every day]

  10. Frequency of alcohol use [Change from baseline to 3 months]

    Number of days used in the past 30 days. [ 0 to 30]

  11. Frequency of alcohol use [Change from baseline to 6 months]

    Number of days used in the past 30 days [ 0 to 30]

  12. Frequency of alcohol use [Change from baseline to 12 months]

    Number of days used in the past 30 days [ 0 to 30]

  13. Alcohol use consequences [Change from baseline to 3 months]

    Number of times in the past 3 months youth experience 4 different alcohol consequences [0 = Never to 6 = 20 or more times]

  14. Alcohol use consequences [Change from baseline to 6 months]

    Number of times in the past 3 months youth experience 4 different alcohol consequences [0 = Never to 6 = 20 or more times]

  15. Alcohol use consequences [Change from baseline to 12 months]

    Number of times in the past 3 months youth experience 4 different alcohol consequences [0 = Never to 6 = 20 or more times]

Secondary Outcome Measures

  1. Sobriety self-efficacy [Change from baseline to 3 months]

    Three items ask how sure youth are about staying sober from alcohol from 1= def drink to 5 = def not drink

  2. Sobriety self-efficacy [Change from baseline to 6 months]

    Three items ask how sure youth are about staying sober from alcohol from 1= def drink to 5 = def not drink

  3. Sobriety self-efficacy [Change from baseline to 12 months]

    Three items ask how sure youth are about staying sober from alcohol from 1= def drink to 5 = def not drink

  4. Intentions to be sober from alcohol [Change from baseline to 3 months]

    Youth report on intentions to be sober in the next 6 months from 1 = def yes to 4 = def no

  5. Intentions to be sober from alcohol [Change from baseline to 6 months]

    Youth report on intentions to be sober in the next 6 months from 1 = def yes to 4 = def no

  6. Intentions to be sober from alcohol [Change from baseline to 12 months]

    Youth report on intentions to be sober in the next 6 months from 1 = def yes to 4 = def no

  7. Social network composition [Change from baseline to 3 months]

    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).

  8. Social network composition [Change from baseline to 6 months]

    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).

  9. Social network composition [Change from baseline to 12 months]

    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).

  10. Social network structure [Change from baseline to 3 months]

    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.

  11. Social network structure [Change from baseline to 6 months]

    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.

  12. Social network structure [Change from baseline to 12 months]

    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.

  13. Time spent around peers who use alcohol [Change from baseline to 3 months]

    Participants will report on how much time is spent around peers who drink from 0 = never to 3 = often

  14. Time spent around peers who use alcohol [Change from baseline to 6 months]

    Participants will report on how much time is spent around peers who drink from 0 = never to 3 = often

  15. Time spent around peers who use alcohol [Change from baseline to 12 months]

    Participants will report on how much time is spent around peers who drink from 0 = never to 3 = often

  16. Awareness of connectedness [Change from baseline to 3 months]

    Youth report on feelings of connectedness to community, family and environment from 1 = strongly agree to 5 strongly disagree

  17. Awareness of connectedness [Change from baseline to 6 months]

    Youth report on feelings of connectedness to community, family and environment from 1 = strongly agree to 5 strongly disagree

  18. Awareness of connectedness [Change from baseline to 12 months]

    Youth report on feelings of connectedness to community, family and environment from 1 = strongly agree to 5 strongly disagree

  19. Community protective factors [Change from baseline to 3 months]

    Youth Community Protective Factors Scale. Youth report on feelings about different protective factors from 1 = strongly agree to 5 strongly disagree

  20. Community protective factors [Change from baseline to 6 months]

    Youth Community Protective Factors Scale Youth report on feelings about different community protective factors from 1 = strongly agree to 5 strongly disagree

  21. Community protective factors [Change from baseline to 12 months]

    Youth Community Protective Factors Scale Youth report on feelings about different community protective factors from 1 = strongly agree to 5 strongly disagree

  22. Individual protective factors [Change from baseline to 3 months]

    Youth report on feelings about different individual protective factors from 1 = strongly agree to 5 strongly disagree

  23. Individual protective factors [Change from baseline to 6 months]

    Youth report on feelings about different individual protective factors from 1 = strongly agree to 5 strongly disagree

  24. Individual protective factors [Change from baseline to 12 months]

    Youth report on feelings about different individual protective factors from 1 = strongly agree to 5 strongly disagree

  25. Reasons for life [Change from baseline to 3 months]

    Brief Reasons for Life Scale from 1 not at all important to 5 very important

  26. Reasons for life [Change from baseline to 6 months]

    Brief Reasons for Life Scale from 1 not at all important to 5 very important

  27. Reasons for life [Change from baseline to 12 months]

    Brief Reasons for Life Scale from 1 not at all important to 5 very important

  28. Reflective processes [Change from baseline to 3 months]

    The Reflective Processes scale taps a culturally patterned type of awareness and youth report from from 1 = strongly agree to 5 strongly disagree

  29. Reflective processes [Change from baseline to 6 months]

    The Reflective Processes scale taps a culturally patterned type of awareness and youth report from from 1 = strongly agree to 5 strongly disagree

  30. Reflective processes [Change from baseline to 12 months]

    The Reflective Processes scale taps a culturally patterned type of awareness and youth report from from 1 = strongly agree to 5 strongly disagree

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 24 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Self-identify as Alaska Native youth

  • Between the ages of 15 and 24

  • Admitted to the hospital for suicide attempt, ideation, or associated risk behaviors including alcohol-related injury or acute intoxication

Exclusion Criteria:

Contacts and Locations

Locations

Site City State Country Postal Code
1 Yukon-Kuskokwim Health Corporation Bethel Alaska United States 99559
2 Tanana Chiefs Conference Fairbanks Alaska United States 99559

Sponsors and Collaborators

  • RAND
  • Patient-Centered Outcomes Research Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
RAND
ClinicalTrials.gov Identifier:
NCT05360888
Other Study ID Numbers:
  • YY46Q97AEZA8
First Posted:
May 4, 2022
Last Update Posted:
May 18, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by RAND
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 18, 2022