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Самоубийственное вмешательство для молодежи коренных жителей Аляски (BeWeL)

22 октября 2026 г. обновлено: Elizabeth D'Amico, RAND

Сравнительная эффективность двух культурно-ориентированных суицидальных вмешательств для молодежи коренных жителей Аляски

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.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Подробное описание

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.

Тип исследования

Интервенционный

Регистрация (Действительный)

302

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

  • Соединенные Штаты
    • Alaska
      • Bethel, Alaska, Соединенные Штаты, 99559
        • Yukon-Kuskokwim Health Corporation
      • Fairbanks, Alaska, Соединенные Штаты, 99559
        • Tanana Chiefs Conference

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 14 лет до 24 года (Ребенок, Взрослый)

Принимает здоровых добровольцев

Да

Полы, имеющие право на обучение

Все

Описание

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:

-

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Профилактика
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Активный компаратор: 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.
Поведенческий: Tools for Life

Tools for Life focuses on empowering youth to learn more about their culture and their identity.
Активный компаратор: 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.
Поведенческий: 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.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Suicide intent/risk
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Sobriety self-efficacy
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

RAND

Соавторы

Patient-Centered Outcomes Research Institute

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

22 декабря 2022 г.

Первичное завершение (Действительный)

31 января 2026 г.

Завершение исследования (Действительный)

31 января 2026 г.

Даты регистрации исследования

Первый отправленный

29 апреля 2022 г.

Впервые представлено, что соответствует критериям контроля качества

29 апреля 2022 г.

Первый опубликованный (Действительный)

4 мая 2022 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

27 октября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

22 октября 2026 г.

Последняя проверка

1 октября 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • SP-2020C3-20879

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

Описание плана IPD

The investigators will share only deidentified, aggregate data.

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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