- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05360888
Suicide Intervention for Alaska Native Youth (BeWel)
February 13, 2024 updated by: RAND
Comparative Effectiveness of Two Culturally-Centered Suicide Interventions for Alaska Native Youth
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
370
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Elizabeth J D'Amico, PhD
- Phone Number: 6487 3103930411
- Email: damico@rand.org
Study Contact Backup
- Name: Stacy Rasmus, PhD
- Phone Number: 907-474-7352
- Email: smrasmus@alaska.edu
Study Locations
-
-
Alaska
-
Bethel, Alaska, United States, 99559
- Recruiting
- Yukon-Kuskokwim Health Corporation
-
Contact:
- Cynthia Nation
-
Fairbanks, Alaska, United States, 99559
- Recruiting
- Tanana Chiefs Conference
-
Contact:
- Cynthia Nation
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 24 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Description
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:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Tools for Life
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 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Suicide intent/risk
Time Frame: Change from baseline to 3 months
|
We will use the Suicidal Ideation Attributes Scale (SIDAS) [0 = Never, 10 = Always]
|
Change from baseline to 3 months
|
Suicide intent/risk
Time Frame: Change from baseline to 6 months
|
We will use the Suicidal Ideation Attributes Scale (SIDAS) [0 = Never, 10 = Always]
|
Change from baseline to 6 months
|
Suicide intent/risk
Time Frame: Change from baseline to 12 months
|
We will use the Suicidal Ideation Attributes Scale (SIDAS) [0 = Never, 10 = Always]
|
Change from baseline to 12 months
|
Depression
Time Frame: Change from baseline to 3 months
|
Patient Health Questionnaire (PHQ-9) [0 -not at all to 3-nearly every day]
|
Change from baseline to 3 months
|
Depression
Time Frame: Change from baseline to 6 months
|
Patient Health Questionnaire (PHQ-9) [0 -not at all to 3-nearly every day]
|
Change from baseline to 6 months
|
Depression
Time Frame: Change from baseline to 12 months
|
Patient Health Questionnaire (PHQ-9) [0 -not at all to 3-nearly every day]
|
Change from baseline to 12 months
|
Anxiety
Time Frame: Change from baseline to 3 months
|
Generalized Anxiety Disorder scale (GAD-7) [0 -not at all to 3-nearly every day]
|
Change from baseline to 3 months
|
Anxiety
Time Frame: Change from baseline to 6 months
|
Generalized Anxiety Disorder scale (GAD-7) [0 -not at all to 3-nearly every day]
|
Change from baseline to 6 months
|
Anxiety
Time Frame: Change from baseline to 12 months
|
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
Time Frame: Change from baseline to 3 months
|
Number of days used in the past 30 days.
[ 0 to 30]
|
Change from baseline to 3 months
|
Frequency of alcohol use
Time Frame: Change from baseline to 6 months
|
Number of days used in the past 30 days [ 0 to 30]
|
Change from baseline to 6 months
|
Frequency of alcohol use
Time Frame: Change from baseline to 12 months
|
Number of days used in the past 30 days [ 0 to 30]
|
Change from baseline to 12 months
|
Alcohol use consequences
Time Frame: 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]
|
Change from baseline to 3 months
|
Alcohol use consequences
Time Frame: 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]
|
Change from baseline to 6 months
|
Alcohol use consequences
Time Frame: 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]
|
Change from baseline to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sobriety self-efficacy
Time Frame: 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
|
Change from baseline to 3 months
|
Sobriety self-efficacy
Time Frame: 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
|
Change from baseline to 6 months
|
Sobriety self-efficacy
Time Frame: 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
|
Change from baseline to 12 months
|
Intentions to be sober from alcohol
Time Frame: 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
|
Change from baseline to 3 months
|
Intentions to be sober from alcohol
Time Frame: 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
|
Change from baseline to 6 months
|
Intentions to be sober from alcohol
Time Frame: 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
|
Change from baseline to 12 months
|
Social network composition
Time Frame: 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).
|
Change from baseline to 3 months
|
Social network composition
Time Frame: 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).
|
Change from baseline to 6 months
|
Social network composition
Time Frame: 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).
|
Change from baseline to 12 months
|
Social network structure
Time Frame: 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.
|
Change from baseline to 3 months
|
Social network structure
Time Frame: 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.
|
Change from baseline to 6 months
|
Social network structure
Time Frame: 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.
|
Change from baseline to 12 months
|
Time spent around peers who use alcohol
Time Frame: 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
|
Change from baseline to 3 months
|
Time spent around peers who use alcohol
Time Frame: 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
|
Change from baseline to 6 months
|
Time spent around peers who use alcohol
Time Frame: 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
|
Change from baseline to 12 months
|
Awareness of connectedness
Time Frame: 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
|
Change from baseline to 3 months
|
Awareness of connectedness
Time Frame: 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
|
Change from baseline to 6 months
|
Awareness of connectedness
Time Frame: 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
|
Change from baseline to 12 months
|
Community protective factors
Time Frame: 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
|
Change from baseline to 3 months
|
Community protective factors
Time Frame: 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
|
Change from baseline to 6 months
|
Community protective factors
Time Frame: 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
|
Change from baseline to 12 months
|
Individual protective factors
Time Frame: Change from baseline to 3 months
|
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
Time Frame: Change from baseline to 6 months
|
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
Time Frame: Change from baseline to 12 months
|
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
Time Frame: Change from baseline to 3 months
|
Brief Reasons for Life Scale from 1 not at all important to 5 very important
|
Change from baseline to 3 months
|
Reasons for life
Time Frame: Change from baseline to 6 months
|
Brief Reasons for Life Scale from 1 not at all important to 5 very important
|
Change from baseline to 6 months
|
Reasons for life
Time Frame: Change from baseline to 12 months
|
Brief Reasons for Life Scale from 1 not at all important to 5 very important
|
Change from baseline to 12 months
|
Reflective processes
Time Frame: 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
|
Change from baseline to 3 months
|
Reflective processes
Time Frame: 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
|
Change from baseline to 6 months
|
Reflective processes
Time Frame: 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
|
Change from baseline to 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 22, 2022
Primary Completion (Estimated)
March 1, 2026
Study Completion (Estimated)
May 1, 2026
Study Registration Dates
First Submitted
April 29, 2022
First Submitted That Met QC Criteria
April 29, 2022
First Posted (Actual)
May 4, 2022
Study Record Updates
Last Update Posted (Actual)
February 16, 2024
Last Update Submitted That Met QC Criteria
February 13, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- YY46Q97AEZA8
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
The investigators will share only deidentified, aggregate data.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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