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Suicide Intervention for Alaska Native Youth (BeWel)

Primary Purpose

Alaska Native Youth Aged 15 - 24, Suicide, Attempted, Suicidal Ideation

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tools for Life
Tools for Life + MISN
Sponsored by
RAND
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alaska Native Youth Aged 15 - 24 focused on measuring Alaska Native youth, suicide, prevention, culture

Eligibility Criteria

15 Years - 24 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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:

-

Sites / Locations

  • Yukon-Kuskokwim Health CorporationRecruiting
  • Tanana Chiefs ConferenceRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Tools for Life

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

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Suicide intent/risk
We will use the Suicidal Ideation Attributes Scale (SIDAS) [0 = Never, 10 = Always]
Suicide intent/risk
We will use the Suicidal Ideation Attributes Scale (SIDAS) [0 = Never, 10 = Always]
Suicide intent/risk
We will use the Suicidal Ideation Attributes Scale (SIDAS) [0 = Never, 10 = Always]
Depression
Patient Health Questionnaire (PHQ-9) [0 -not at all to 3-nearly every day]
Depression
Patient Health Questionnaire (PHQ-9) [0 -not at all to 3-nearly every day]
Depression
Patient Health Questionnaire (PHQ-9) [0 -not at all to 3-nearly every day]
Anxiety
Generalized Anxiety Disorder scale (GAD-7) [0 -not at all to 3-nearly every day]
Anxiety
Generalized Anxiety Disorder scale (GAD-7) [0 -not at all to 3-nearly every day]
Anxiety
Generalized Anxiety Disorder scale (GAD-7) [0 -not at all to 3-nearly every day]
Frequency of alcohol use
Number of days used in the past 30 days. [ 0 to 30]
Frequency of alcohol use
Number of days used in the past 30 days [ 0 to 30]
Frequency of alcohol use
Number of days used in the past 30 days [ 0 to 30]
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]
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]
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]

Secondary Outcome Measures

Sobriety self-efficacy
Three items ask how sure youth are about staying sober from alcohol from 1= def drink to 5 = def not drink
Sobriety self-efficacy
Three items ask how sure youth are about staying sober from alcohol from 1= def drink to 5 = def not drink
Sobriety self-efficacy
Three items ask how sure youth are about staying sober from alcohol from 1= def drink to 5 = def not drink
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
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
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
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).
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).
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).
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.
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.
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.
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
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
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
Awareness of connectedness
Youth report on feelings of connectedness to community, family and environment from 1 = strongly agree to 5 strongly disagree
Awareness of connectedness
Youth report on feelings of connectedness to community, family and environment from 1 = strongly agree to 5 strongly disagree
Awareness of connectedness
Youth report on feelings of connectedness to community, family and environment from 1 = strongly agree to 5 strongly disagree
Community protective factors
Youth Community Protective Factors Scale. Youth report on feelings about different protective factors from 1 = strongly agree to 5 strongly disagree
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
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
Individual protective factors
Youth report on feelings about different individual protective factors from 1 = strongly agree to 5 strongly disagree
Individual protective factors
Youth report on feelings about different individual protective factors from 1 = strongly agree to 5 strongly disagree
Individual protective factors
Youth report on feelings about different individual protective factors from 1 = strongly agree to 5 strongly disagree
Reasons for life
Brief Reasons for Life Scale from 1 not at all important to 5 very important
Reasons for life
Brief Reasons for Life Scale from 1 not at all important to 5 very important
Reasons for life
Brief Reasons for Life Scale from 1 not at all important to 5 very important
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
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
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

Full Information

First Posted
April 29, 2022
Last Updated
May 1, 2023
Sponsor
RAND
Collaborators
Patient-Centered Outcomes Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05360888
Brief Title
Suicide Intervention for Alaska Native Youth
Acronym
BeWel
Official Title
Comparative Effectiveness of Two Culturally-Centered Suicide Interventions for Alaska Native Youth
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 22, 2022 (Actual)
Primary Completion Date
March 2026 (Anticipated)
Study Completion Date
May 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RAND
Collaborators
Patient-Centered Outcomes Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alaska Native Youth Aged 15 - 24, Suicide, Attempted, Suicidal Ideation, Alcohol Intoxication
Keywords
Alaska Native youth, suicide, prevention, culture

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
370 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tools for Life
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Tools for Life + Motivational Interviewing Social Network intervention (MISN)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Tools for Life
Intervention Description
Tools for Life focuses on empowering youth to learn more about their culture and their identity.
Intervention Type
Behavioral
Intervention Name(s)
Tools for Life + MISN
Intervention Description
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.
Primary Outcome Measure Information:
Title
Suicide intent/risk
Description
We will use the Suicidal Ideation Attributes Scale (SIDAS) [0 = Never, 10 = Always]
Time Frame
Change from baseline to 3 months
Title
Suicide intent/risk
Description
We will use the Suicidal Ideation Attributes Scale (SIDAS) [0 = Never, 10 = Always]
Time Frame
Change from baseline to 6 months
Title
Suicide intent/risk
Description
We will use the Suicidal Ideation Attributes Scale (SIDAS) [0 = Never, 10 = Always]
Time Frame
Change from baseline to 12 months
Title
Depression
Description
Patient Health Questionnaire (PHQ-9) [0 -not at all to 3-nearly every day]
Time Frame
Change from baseline to 3 months
Title
Depression
Description
Patient Health Questionnaire (PHQ-9) [0 -not at all to 3-nearly every day]
Time Frame
Change from baseline to 6 months
Title
Depression
Description
Patient Health Questionnaire (PHQ-9) [0 -not at all to 3-nearly every day]
Time Frame
Change from baseline to 12 months
Title
Anxiety
Description
Generalized Anxiety Disorder scale (GAD-7) [0 -not at all to 3-nearly every day]
Time Frame
Change from baseline to 3 months
Title
Anxiety
Description
Generalized Anxiety Disorder scale (GAD-7) [0 -not at all to 3-nearly every day]
Time Frame
Change from baseline to 6 months
Title
Anxiety
Description
Generalized Anxiety Disorder scale (GAD-7) [0 -not at all to 3-nearly every day]
Time Frame
Change from baseline to 12 months
Title
Frequency of alcohol use
Description
Number of days used in the past 30 days. [ 0 to 30]
Time Frame
Change from baseline to 3 months
Title
Frequency of alcohol use
Description
Number of days used in the past 30 days [ 0 to 30]
Time Frame
Change from baseline to 6 months
Title
Frequency of alcohol use
Description
Number of days used in the past 30 days [ 0 to 30]
Time Frame
Change from baseline to 12 months
Title
Alcohol use consequences
Description
Number of times in the past 3 months youth experience 4 different alcohol consequences [0 = Never to 6 = 20 or more times]
Time Frame
Change from baseline to 3 months
Title
Alcohol use consequences
Description
Number of times in the past 3 months youth experience 4 different alcohol consequences [0 = Never to 6 = 20 or more times]
Time Frame
Change from baseline to 6 months
Title
Alcohol use consequences
Description
Number of times in the past 3 months youth experience 4 different alcohol consequences [0 = Never to 6 = 20 or more times]
Time Frame
Change from baseline to 12 months
Secondary Outcome Measure Information:
Title
Sobriety self-efficacy
Description
Three items ask how sure youth are about staying sober from alcohol from 1= def drink to 5 = def not drink
Time Frame
Change from baseline to 3 months
Title
Sobriety self-efficacy
Description
Three items ask how sure youth are about staying sober from alcohol from 1= def drink to 5 = def not drink
Time Frame
Change from baseline to 6 months
Title
Sobriety self-efficacy
Description
Three items ask how sure youth are about staying sober from alcohol from 1= def drink to 5 = def not drink
Time Frame
Change from baseline to 12 months
Title
Intentions to be sober from alcohol
Description
Youth report on intentions to be sober in the next 6 months from 1 = def yes to 4 = def no
Time Frame
Change from baseline to 3 months
Title
Intentions to be sober from alcohol
Description
Youth report on intentions to be sober in the next 6 months from 1 = def yes to 4 = def no
Time Frame
Change from baseline to 6 months
Title
Intentions to be sober from alcohol
Description
Youth report on intentions to be sober in the next 6 months from 1 = def yes to 4 = def no
Time Frame
Change from baseline to 12 months
Title
Social network composition
Description
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).
Time Frame
Change from baseline to 3 months
Title
Social network composition
Description
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).
Time Frame
Change from baseline to 6 months
Title
Social network composition
Description
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).
Time Frame
Change from baseline to 12 months
Title
Social network structure
Description
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.
Time Frame
Change from baseline to 3 months
Title
Social network structure
Description
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.
Time Frame
Change from baseline to 6 months
Title
Social network structure
Description
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.
Time Frame
Change from baseline to 12 months
Title
Time spent around peers who use alcohol
Description
Participants will report on how much time is spent around peers who drink from 0 = never to 3 = often
Time Frame
Change from baseline to 3 months
Title
Time spent around peers who use alcohol
Description
Participants will report on how much time is spent around peers who drink from 0 = never to 3 = often
Time Frame
Change from baseline to 6 months
Title
Time spent around peers who use alcohol
Description
Participants will report on how much time is spent around peers who drink from 0 = never to 3 = often
Time Frame
Change from baseline to 12 months
Title
Awareness of connectedness
Description
Youth report on feelings of connectedness to community, family and environment from 1 = strongly agree to 5 strongly disagree
Time Frame
Change from baseline to 3 months
Title
Awareness of connectedness
Description
Youth report on feelings of connectedness to community, family and environment from 1 = strongly agree to 5 strongly disagree
Time Frame
Change from baseline to 6 months
Title
Awareness of connectedness
Description
Youth report on feelings of connectedness to community, family and environment from 1 = strongly agree to 5 strongly disagree
Time Frame
Change from baseline to 12 months
Title
Community protective factors
Description
Youth Community Protective Factors Scale. Youth report on feelings about different protective factors from 1 = strongly agree to 5 strongly disagree
Time Frame
Change from baseline to 3 months
Title
Community protective factors
Description
Youth Community Protective Factors Scale Youth report on feelings about different community protective factors from 1 = strongly agree to 5 strongly disagree
Time Frame
Change from baseline to 6 months
Title
Community protective factors
Description
Youth Community Protective Factors Scale Youth report on feelings about different community protective factors from 1 = strongly agree to 5 strongly disagree
Time Frame
Change from baseline to 12 months
Title
Individual protective factors
Description
Youth report on feelings about different individual protective factors from 1 = strongly agree to 5 strongly disagree
Time Frame
Change from baseline to 3 months
Title
Individual protective factors
Description
Youth report on feelings about different individual protective factors from 1 = strongly agree to 5 strongly disagree
Time Frame
Change from baseline to 6 months
Title
Individual protective factors
Description
Youth report on feelings about different individual protective factors from 1 = strongly agree to 5 strongly disagree
Time Frame
Change from baseline to 12 months
Title
Reasons for life
Description
Brief Reasons for Life Scale from 1 not at all important to 5 very important
Time Frame
Change from baseline to 3 months
Title
Reasons for life
Description
Brief Reasons for Life Scale from 1 not at all important to 5 very important
Time Frame
Change from baseline to 6 months
Title
Reasons for life
Description
Brief Reasons for Life Scale from 1 not at all important to 5 very important
Time Frame
Change from baseline to 12 months
Title
Reflective processes
Description
The Reflective Processes scale taps a culturally patterned type of awareness and youth report from from 1 = strongly agree to 5 strongly disagree
Time Frame
Change from baseline to 3 months
Title
Reflective processes
Description
The Reflective Processes scale taps a culturally patterned type of awareness and youth report from from 1 = strongly agree to 5 strongly disagree
Time Frame
Change from baseline to 6 months
Title
Reflective processes
Description
The Reflective Processes scale taps a culturally patterned type of awareness and youth report from from 1 = strongly agree to 5 strongly disagree
Time Frame
Change from baseline to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth J D'Amico, PhD
Phone
3103930411
Ext
6487
Email
damico@rand.org
First Name & Middle Initial & Last Name or Official Title & Degree
Stacy Rasmus, PhD
Phone
907-474-7352
Email
smrasmus@alaska.edu
Facility Information:
Facility Name
Yukon-Kuskokwim Health Corporation
City
Bethel
State/Province
Alaska
ZIP/Postal Code
99559
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cynthia Nation
Facility Name
Tanana Chiefs Conference
City
Fairbanks
State/Province
Alaska
ZIP/Postal Code
99559
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cynthia Nation

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The investigators will share only deidentified, aggregate data.

Learn more about this trial

Suicide Intervention for Alaska Native Youth

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