Southwest Hub for American Indian Youth Suicide Prevention Research
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 304
- 试验地点
- 1
- 主要终点
- Suicide Ideation Questionnaire (SIQ)
研究概览
简要总结
- To use a SMART design to evaluate which of four sequences of New Hope (NH), Elders Resilience (ER) and Case Management (CM) have the greater effects on immediate and longer-term suicidal ideation (primary outcome) and resilience (secondary outcome) among American Indian (AI) adolescents ages 10-29 identified at risk for suicide.
Hypotheses:
i. New Hope vs. CM alone will significantly reduce participant suicidal ideation.
ii. Elders Resilience vs. CM alone will significantly improve participant resilience.
iii. New Hope followed by Elders Resilience will have the strongest effects on suicidal ideation and resilience.
iv. CM alone will have the weakest effects of all combinations.
Secondary Aims: 2. To examine mediators and moderators of treatment effectiveness and sequencing in order to determine which types and sequence of interventions is best suited for which youth. 3. To assess the acceptability, feasibility and capacity for sustainability of the Hub's key intervention components (Surveillance/Case Management, New Hope and Elders' Resilience) from the perspective of multiple stakeholders as they are implemented across different tribes.
详细描述
The overall goal of the research component of the National Institute of Mental Health funded Southwest Hub for American Indian Youth Suicide Prevention Research is to identify effective, feasible and sustainable interventions to prevent suicide and promote resilience among American Indian (AI) youth. The proposed study will build on 20+ years of behavioral and mental health research and partnerships undertaken by the Center for American Indian Health (CAIH) at Johns Hopkins with the White Mountain Apache Tribe (WMAT).
The investigators primary research aim, to be undertaken with the White Mountain Apache, includes: 1) identification and voluntary enrollment of youth 10-29 years old using the WMAT established surveillance and case-management (CM) system who recently had a validated suicide attempt, ideation, or binge substance use episode with recent suicidal ideation; and 2) implementation of a Sequential Multiple Assignment Randomized Trial (SMART) to inform how to combine and tailor two brief interventions delivered by paraprofessional community mental health workers (CMHWs), with promising pilot data, to prevent further suicidal thoughts and behavior and promote resilience; and 3) evaluate what are the cost savings per study participant with the implementation of the Southwest Hub interventions: NH, ER, NH and ER. A secondary aim will be to evaluate the acceptability, feasibility and sustainability of the two brief interventions with other Southwest Hub partners, including the Navajo, San Carlos Apache, Hualapai, and Cherokee nations, who will have support from the Administrative Core of the Southwest Hub to implement their own local tribal suicide surveillance systems for community-based identification of at-risk youth.
The investigators will employ a SMART design to evaluate the effectiveness of New Hope (NH), Elders' Resilience intervention (ER), Case Management (CM) and the combination of these approaches on reducing suicidal thoughts and promoting resilience among AI youth ages 10-29 who are confirmed by surveillance case managers to have recently experienced suicide ideation, attempt or a binge substance use and ideation. Youth who assent will complete the baseline (case management visit 1 and will be referred to mental health care-the standard protocol for the Apache system). During the same visit, youth will be randomized 1:1 to either New Hope (NH) plus Case Management (CM), or CM alone, using a blocked randomized design, stratifying participants by age and event type. All youth will complete another study assessment after 30 days. The 30-day time frame will allow ample time to complete the NH intervention with participants and assess any changes in youth's mental health status for all study arms. Following another 30-day period, all participants will be re-assessed and re-randomized, using the same blocking and 1:1 ratio to either the Elders' Resilience (ER) intervention plus CM, or CM alone. To track long term outcomes, all youth will complete a final assessment 3 month later (6 months post-enrollment). This study will occur on the White Mountain Apache Tribe's Fort Apache reservation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 29 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria:
- •Native American youth ages 10 to 29 years old.
- •Reside on or near the Fort Apache Indian Reservation.
- •Parent/guardian consent for youth under 18 years old.
- •Suicide ideation, binge substance use with recent (i.e. within the last 3 months) suicide ideation, or suicide attempt in the past 30 days as identified and verified by the surveillance system or release from inpatient care related to suicide ideation or attempt within past 30 days.
- •Terms and Definitions: Definitions for reportable behaviors are modeled on the Columbia Classification Algorithm for Suicide Assessment (C- CASA).[11] Suicide attempt: intentional self-injury with intent to die. (Aborted and interrupted suicide attempts are included as part of this category). Suicidal ideation: thoughts to take one's own life with or without preparatory action. Binge substance use with recent ideation, defined by Apache stakeholders, as consuming substances with the intention of modifying consciousness and resulting in being found unresponsive or requiring ED treatment and answering positively to a 1-item screening question on the assessment indicating suicide ideation within the past three months.
排除标准
- •Factors identified at baseline that preclude full participation, including: unstable and severe medical, psychiatric or drug use problem that necessitates inpatient treatment; acute suicidal or homicidal ideation requiring immediate intervention; recent, severe stressful life events such as physical or sexual abuse, or violent crime victimization that requires specific and high intensity interventions or out of home placement. Participants must speak English and not be severely visually impaired. Foster children will not be included. Ambiguous cases will be reviewed by one of the co-PIs before being deemed eligible for recruitment.
- •Inclusion Criteria:
- •Youth over the age of 16 or adults over the age of
- •A person with an interest or concern related to youth suicide among AI populations.
- •Exclusion Criteria:
- •Factors identified at baseline that preclude full participation including: being under the influence of a substance; active psychosis or mania; any other condition that makes an individual lack capacity to give consent. Foster children will not be included. Participants must speak English and not be severely visually impaired. Ambiguous cases will be reviewed by one of the co-PIs before being deemed eligible for recruitment.
研究组 & 干预措施
New Hope (NH)
The investigators will employ a SMART design to evaluate the effectiveness of New Hope (NH), Elders' Resilience intervention (ER), Case Management (CM) and the combination of these approaches on reducing suicidal thoughts and promoting resilience among AI youth ages 10-29 who are confirmed by surveillance case managers to have recently experienced suicide ideation, attempt or a binge substance use and ideation.
Youth who assent will complete the baseline (CM visit 1 and will be referred to mental health care). During the same visit, youth will be randomized 1:1 to either New Hope (NH) plus Case Management (CM), or CM alone, using a blocked randomized design, stratifying participants by age and event type.
干预措施: New Hope (NH) (Behavioral)
New Hope (NH)
The investigators will employ a SMART design to evaluate the effectiveness of New Hope (NH), Elders' Resilience intervention (ER), Case Management (CM) and the combination of these approaches on reducing suicidal thoughts and promoting resilience among AI youth ages 10-29 who are confirmed by surveillance case managers to have recently experienced suicide ideation, attempt or a binge substance use and ideation.
Youth who assent will complete the baseline (CM visit 1 and will be referred to mental health care). During the same visit, youth will be randomized 1:1 to either New Hope (NH) plus Case Management (CM), or CM alone, using a blocked randomized design, stratifying participants by age and event type.
干预措施: Case Management (CM) (Other)
Elders' Resiliency (ER)
The investigators will employ a SMART design to evaluate the effectiveness of New Hope (NH), Elders' Resilience intervention (ER), Case Management (CM) and the combination of these approaches on reducing suicidal thoughts and promoting resilience among AI youth ages 10-29 who are confirmed by surveillance case managers to have recently experienced suicide ideation, attempt or a binge substance use and ideation.
All youth will complete another study assessment after 30 days. The 30-day time frame will allow ample time to complete the NH intervention with participants and assess any changes in youth's mental health status for all study arms. Following another 30-day period, all participants will be re-assessed and re-randomized, using the same blocking and 1:1 ratio to either the Elders' Resilience (ER) intervention plus CM, or CM alone. To track long term outcomes, all youth will complete a final assessment 3 month later (6 months post-enrollment).
干预措施: Elders Resilience (ER) (Behavioral)
Elders' Resiliency (ER)
The investigators will employ a SMART design to evaluate the effectiveness of New Hope (NH), Elders' Resilience intervention (ER), Case Management (CM) and the combination of these approaches on reducing suicidal thoughts and promoting resilience among AI youth ages 10-29 who are confirmed by surveillance case managers to have recently experienced suicide ideation, attempt or a binge substance use and ideation.
All youth will complete another study assessment after 30 days. The 30-day time frame will allow ample time to complete the NH intervention with participants and assess any changes in youth's mental health status for all study arms. Following another 30-day period, all participants will be re-assessed and re-randomized, using the same blocking and 1:1 ratio to either the Elders' Resilience (ER) intervention plus CM, or CM alone. To track long term outcomes, all youth will complete a final assessment 3 month later (6 months post-enrollment).
干预措施: Case Management (CM) (Other)
Control Condition
The control condition will only receive Case Management (CM) (n=76).
The investigators will employ a SMART design to evaluate the effectiveness of New Hope (NH), Elders' Resilience intervention (ER), Case Management (CM) and the combination of these approaches on reducing suicidal thoughts and promoting resilience among AI youth ages 10-29 who are confirmed by surveillance case managers to have recently experienced suicide ideation, attempt or a binge substance use and ideation. Youth who assent will complete the baseline (CM visit 1 and will be referred to mental health care). During the same visit, youth will be randomized 1:1 to either New Hope (NH) plus Case Management (CM), or CM alone, using a blocked randomized design, stratifying participants by age and event type.
干预措施: Case Management (CM) (Other)
New Hope (NH), Elders' Resiliency (ER), Case Management (CM)
The investigators will employ a SMART design to evaluate the effectiveness of New Hope (NH), Elders' Resilience intervention (ER), Case Management (CM) and the combination of these approaches on reducing suicidal thoughts and promoting resilience among AI youth ages 10-29 who are confirmed by surveillance case managers to have recently experienced suicide ideation, attempt or a binge substance use and ideation. Youth who assent will complete the baseline (CM visit 1 and will be referred to mental health care). During the same visit, youth will be randomized 1:1 to either New Hope (NH) plus Case Management (CM), or CM alone, using a blocked randomized design, stratifying participants by age and event type. All youth will complete another study assessment after 30 days.After another 30-days, all participants will be re-assessed/re-randomized, using the same blocking and 1:1 ratio to either the ER intervention plus CM, or CM alone.
干预措施: New Hope (NH) (Behavioral)
New Hope (NH), Elders' Resiliency (ER), Case Management (CM)
The investigators will employ a SMART design to evaluate the effectiveness of New Hope (NH), Elders' Resilience intervention (ER), Case Management (CM) and the combination of these approaches on reducing suicidal thoughts and promoting resilience among AI youth ages 10-29 who are confirmed by surveillance case managers to have recently experienced suicide ideation, attempt or a binge substance use and ideation. Youth who assent will complete the baseline (CM visit 1 and will be referred to mental health care). During the same visit, youth will be randomized 1:1 to either New Hope (NH) plus Case Management (CM), or CM alone, using a blocked randomized design, stratifying participants by age and event type. All youth will complete another study assessment after 30 days.After another 30-days, all participants will be re-assessed/re-randomized, using the same blocking and 1:1 ratio to either the ER intervention plus CM, or CM alone.
干预措施: Elders Resilience (ER) (Behavioral)
New Hope (NH), Elders' Resiliency (ER), Case Management (CM)
The investigators will employ a SMART design to evaluate the effectiveness of New Hope (NH), Elders' Resilience intervention (ER), Case Management (CM) and the combination of these approaches on reducing suicidal thoughts and promoting resilience among AI youth ages 10-29 who are confirmed by surveillance case managers to have recently experienced suicide ideation, attempt or a binge substance use and ideation. Youth who assent will complete the baseline (CM visit 1 and will be referred to mental health care). During the same visit, youth will be randomized 1:1 to either New Hope (NH) plus Case Management (CM), or CM alone, using a blocked randomized design, stratifying participants by age and event type. All youth will complete another study assessment after 30 days.After another 30-days, all participants will be re-assessed/re-randomized, using the same blocking and 1:1 ratio to either the ER intervention plus CM, or CM alone.
干预措施: Case Management (CM) (Other)
结局指标
主要结局
Suicide Ideation Questionnaire (SIQ)
时间窗: Baseline, 30 days, 60 days, 90 days, 180 days
The SIQ for adults (ages \>14; 27 items) and SIQ-Junior for youth (ages ≤14; 13 items). Both measure frequency of suicidal thoughts on a 7-point Likert scale (0=Never to 6=Almost Every Day). Raw scores range from 0-162 (SIQ) and 0-78 (SIQ-JR); higher raw scores indicate greater suicidal ideation. Raw scores of ≥30 on the SIQ and ≥23 on the SIQ-JR indicate clinically severe suicidal ideation. To create comparable scores across age groups, raw scores were converted to z-scores based on the study sample's baseline distribution, calculated separately for adults and youth using their respective scale versions. A constant of 10 was added to all z-scores to facilitate interpretation. Interpretation of Z-scores: * Each unit change represents one standard deviation from the sample * Z-scores \>10 indicate above-average suicidal ideation (worse outcome) * Z-scores \<10 indicate below-average suicidal ideation (better outcome) A Z-score of 0 represents the population mean
The Resiliency Scales
时间窗: Baseline, 30 days, 60 days, 90 days, 180 days
Resilience Scales for Children and Adolescents (RSCA), adapted and validated with community input. The RSCA measures 3 domains of resilience using a 4-point Likert scale (0=Not at All, 1=A little bit, 2=A medium amount, 3=A lot): * Sense of Mastery: 20 items assessing self-efficacy and control (range: 0-60; higher better) * Sense of Relatedness: 18 items assessing trust and support from relationships (range: 0-54; higher better) * Emotional Reactivity: 24 items assessing vulnerability to stress and negative emotions (range: 0-72; lower better) 1. Items are summed within each subscale 2. Mastery and Relatedness subscales are summed to create a Resource Index (range: 0-114) 3. The Total Resilience Score is calculated as: Resource Index minus Emotional Reactivity Total Resilience Score Range: -72 to 114 Interpretation: * Higher scores indicate greater resilience (better outcome) * Better scores reflect more personal and relational resources combined with lower emotional vulnerab
次要结局
- Centers for Epidemiologic Studies of Depression (CESDR-10)(Baseline, 30 days, 60 days, 90 days, 180 days)
- The Children's Hope Scale (CHS)(Baseline, 30 days, 60 days, 90 days, 180 days)
- Multicultural Mastery Scale(Baseline, 30 days, 60 days, 90 days, 180 days)
- Rosenberg Self Esteem Scale(Baseline, 30 days, 60 days, 90 days, 180 days)
- Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) Risk Score(Baseline, 30 days, 60 days, 90 days, 180 days)