アラスカ先住民の若者への自殺介入 (BeWeL)
アラスカ先住民の若者に対する 2 つの文化中心の自殺介入の有効性の比較
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Alaska
-
Bethel、Alaska、アメリカ、99559
- Yukon-Kuskokwim Health Corporation
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Fairbanks、Alaska、アメリカ、99559
- Tanana Chiefs Conference
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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:
-
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：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. |
|
アクティブコンパレータ：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Suicide intent/risk
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Sobriety self-efficacy
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
出版物と役立つリンク
一般刊行物
- Rasmus S, D'Amico EJ, Allen J, Nation C, John S, Joseph V, Rodriguez A, Alvarado G, Gittens AD, Palimaru AI, Brown RA, Kennedy DP, Woodward MJ, Parker J, McDonald K. A protocol for a randomized controlled comparative effectiveness trial of two brief interventions focused on social and cultural connectedness to reduce risk for suicide and substance misuse in young Alaska Native people. BMC Public Health. 2025 Oct 15;25(1):3503. doi: 10.1186/s12889-025-24710-z.
- Rasmus S, D'Amico EJ, Allen J, Nation C, John S, Joseph V, Rodriguez A, Alvarado G, Gittens AD, Palimaru AI, Brown RA, Kennedy DP, Woodward MJ, Parker J, McDonald K. Because We Love You (BeWeL): A protocol for a randomized controlled trial of two brief interventions focused on social and cultural connectedness to reduce risk for suicide and substance misuse in young Alaska Native people. Res Sq [Preprint]. 2024 Jan 22:rs.3.rs-3874293. doi: 10.21203/rs.3.rs-3874293/v1.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- SP-2020C3-20879
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
The investigators will share only deidentified, aggregate data.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。