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Zelfmoordinterventie voor inheemse jongeren in Alaska (BeWeL)

22 oktober 2026 bijgewerkt door: Elizabeth D'Amico, RAND

Vergelijkende effectiviteit van twee cultureel gerichte zelfmoordinterventies voor inheemse jongeren in 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

302

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Alaska
      • Bethel, Alaska, Verenigde Staten, 99559
        • Yukon-Kuskokwim Health Corporation
      • Fairbanks, Alaska, Verenigde Staten, 99559
        • Tanana Chiefs Conference

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

14 jaar tot 24 jaar (Kind, Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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:

-

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 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.
Gedragsmatig: Tools for Life

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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Suicide intent/risk
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Sobriety self-efficacy
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

RAND

Medewerkers

Patient-Centered Outcomes Research Institute

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

22 december 2022

Primaire voltooiing (Werkelijk)

31 januari 2026

Studie voltooiing (Werkelijk)

31 januari 2026

Studieregistratiedata

Eerst ingediend

29 april 2022

Eerst ingediend dat voldeed aan de QC-criteria

29 april 2022

Eerst geplaatst (Werkelijk)

4 mei 2022

Updates van studierecords

Laatste update geplaatst (Werkelijk)

27 oktober 2026

Laatste update ingediend die voldeed aan QC-criteria

22 oktober 2026

Laatst geverifieerd

1 oktober 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • SP-2020C3-20879

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

The investigators will share only deidentified, aggregate data.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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