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Självmordsingripande för Alaska Native Youth (BeWeL)

22 oktober 2026 uppdaterad av: Elizabeth D'Amico, RAND

Jämförande effektivitet av två kulturellt centrerade självmordsinterventioner för unga från Alaska

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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

302

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Alaska
      • Bethel, Alaska, Förenta staterna, 99559
        • Yukon-Kuskokwim Health Corporation
      • Fairbanks, Alaska, Förenta staterna, 99559
        • Tanana Chiefs Conference

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

14 år till 24 år (Barn, Vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

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:

-

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: 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.
Beteende: Tools for Life

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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Suicide intent/risk
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Sobriety self-efficacy
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

RAND

Samarbetspartners

Patient-Centered Outcomes Research Institute

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

22 december 2022

Primärt slutförande (Faktisk)

31 januari 2026

Avslutad studie (Faktisk)

31 januari 2026

Studieregistreringsdatum

Först inskickad

29 april 2022

Först inskickad som uppfyllde QC-kriterierna

29 april 2022

Första postat (Faktisk)

4 maj 2022

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

27 oktober 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

22 oktober 2026

Senast verifierad

1 oktober 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • SP-2020C3-20879

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

The investigators will share only deidentified, aggregate data.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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