Suicide Intervention for Alaska Native Youth

Suicidal Ideation Clinical Trial

— BeWeL  

Official title:

Comparative Effectiveness of Two Culturally-Centered Suicide Interventions for Alaska Native Youth

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05360888
• Other study ID #: YY46Q97AEZA8
• Status: Recruiting
• Phase: N/A
• Start date: December 22, 2022
• Est. completion date: May 2026

Study information

• Verified date: May 2024
• Source: RAND
• Contact: Elizabeth J D'Amico, PhD
• Phone: 3103930411
• Email: damico[@]rand.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 370
• Est. completion date: May 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 24 Years

Eligibility

Inclusion Criteria:

• Self-identify as Alaska Native youth

• Between the ages of 14 and 24

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

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Alcohol Intoxication
• Alcoholic Intoxication
• Suicidal Ideation
• Suicide
• Suicide, Attempted

Intervention

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

Locations

Country	Name	City	State
United States	Yukon-Kuskokwim Health Corporation	Bethel	Alaska
United States	Tanana Chiefs Conference	Fairbanks	Alaska

Sponsors (2)

Lead Sponsor	Collaborator
RAND	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Suicide intent/risk	We will use the Suicidal Ideation Attributes Scale (SIDAS) [0 = Never, 10 = Always]	Change from baseline to 3 months
Primary	Suicide intent/risk	We will use the Suicidal Ideation Attributes Scale (SIDAS) [0 = Never, 10 = Always]	Change from baseline to 6 months
Primary	Suicide intent/risk	We will use the Suicidal Ideation Attributes Scale (SIDAS) [0 = Never, 10 = Always]	Change from baseline to 12 months
Primary	Depression	Patient Health Questionnaire (PHQ-9) [0 -not at all to 3-nearly every day]	Change from baseline to 3 months
Primary	Depression	Patient Health Questionnaire (PHQ-9) [0 -not at all to 3-nearly every day]	Change from baseline to 6 months
Primary	Depression	Patient Health Questionnaire (PHQ-9) [0 -not at all to 3-nearly every day]	Change from baseline to 12 months
Primary	Anxiety	Generalized Anxiety Disorder scale (GAD-7) [0 -not at all to 3-nearly every day]	Change from baseline to 3 months
Primary	Anxiety	Generalized Anxiety Disorder scale (GAD-7) [0 -not at all to 3-nearly every day]	Change from baseline to 6 months
Primary	Anxiety	Generalized Anxiety Disorder scale (GAD-7) [0 -not at all to 3-nearly every day]	Change from baseline to 12 months
Primary	Frequency of alcohol use	Number of days used in the past 30 days. [ 0 to 30]	Change from baseline to 3 months
Primary	Frequency of alcohol use	Number of days used in the past 30 days [ 0 to 30]	Change from baseline to 6 months
Primary	Frequency of alcohol use	Number of days used in the past 30 days [ 0 to 30]	Change from baseline to 12 months
Primary	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
Primary	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
Primary	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
Secondary	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
Secondary	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 6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Reasons for life	Brief Reasons for Life Scale from 1 not at all important to 5 very important	Change from baseline to 3 months
Secondary	Reasons for life	Brief Reasons for Life Scale from 1 not at all important to 5 very important	Change from baseline to 6 months
Secondary	Reasons for life	Brief Reasons for Life Scale from 1 not at all important to 5 very important	Change from baseline to 12 months
Secondary	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
Secondary	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
Secondary	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