알래스카 원주민 청소년을 위한 자살 개입 (BeWeL)
알래스카 원주민 청소년을 위한 두 가지 문화 중심 자살 개입의 비교 효과
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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 장소
-
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Alaska
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Bethel, Alaska, 미국, 99559
- Yukon-Kuskokwim Health Corporation
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Fairbanks, Alaska, 미국, 99559
- Tanana Chiefs Conference
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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:
-
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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활성 비교기: 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. |
|
활성 비교기: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Suicide intent/risk
기간: 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
기간: 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
기간: 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
기간: 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
|
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Depression
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Sobriety self-efficacy
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
협력자
협력자
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (실제)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- SP-2020C3-20879
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
The investigators will share only deidentified, aggregate data.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .