Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

Selbstmordintervention für die Jugend der Ureinwohner Alaskas (BeWeL)

22. Oktober 2026 aktualisiert von: Elizabeth D'Amico, RAND

Vergleichende Wirksamkeit von zwei kulturell zentrierten Selbstmordinterventionen für die Jugend der Ureinwohner Alaskas

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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

302

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Alaska
      • Bethel, Alaska, Vereinigte Staaten, 99559
        • Yukon-Kuskokwim Health Corporation
      • Fairbanks, Alaska, Vereinigte Staaten, 99559
        • Tanana Chiefs Conference

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

14 Jahre bis 24 Jahre (Kind, Erwachsene)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

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:

-

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver 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.
Verhalten: Tools for Life

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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Suicide intent/risk
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Sobriety self-efficacy
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

RAND

Mitarbeiter

Patient-Centered Outcomes Research Institute

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

22. Dezember 2022

Primärer Abschluss (Tatsächlich)

31. Januar 2026

Studienabschluss (Tatsächlich)

31. Januar 2026

Studienanmeldedaten

Zuerst eingereicht

29. April 2022

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

29. April 2022

Zuerst gepostet (Tatsächlich)

4. Mai 2022

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

27. Oktober 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

22. Oktober 2026

Zuletzt verifiziert

1. Oktober 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • SP-2020C3-20879

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

The investigators will share only deidentified, aggregate data.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Abonnieren