| ID | Type | Description | Link |
|---|---|---|---|
| 5U19MH113136-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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:
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.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New Hope (NH) | Experimental | 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. |
|
| Elders' Resiliency (ER) | Experimental | 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). |
|
| Control Condition | Other |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| New Hope (NH) | Behavioral | New Hope will be implemented over 1 visit (2-4 hours) in a youth-preferred setting after Emergency Department (ED) discharge for a suicide attempt, and in the past few years has been updated to also target suicide ideation and binge behavior. NH emphasizes the seriousness of a suicide attempt; teaches coping skills to reduce risk, including emotion regulation, cognitive restructuring, social support, and safety planning; and helps participants overcome barriers to treatment motivation, initiation, and adherence. A center-piece of the intervention is a 20-minute video produced by with Native actors, vignettes specific to this community, and Elders speaking in Apache (with sub-titles) about the seriousness of suicide, its impact on the community, their concern for the adolescent, and beliefs about the communal importance of each individual's life.Youth will be encouraged to choose a support person from his/her family to take part in the intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Suicide Ideation Questionnaire (SIQ) | 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:
| Baseline, 30 days, 60 days, 90 days, 180 days |
| The Resiliency Scales | 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):
Interpretation:
| Baseline, 30 days, 60 days, 90 days, 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| Centers for Epidemiologic Studies of Depression (CESDR-10) | The Centers for Epidemiologic Studies of Depression (CESDR-10) is a self-report scale used to measure depressive symptoms (Cronbach's alpha ranged from 0.90 to 0.91 in a validation study). Scores on the CESDR-10 range from 0 (minimum) to 40 (maximum) with higher scores representing higher frequency of experiencing depression symptoms. CESDR-10 score is summed to provide an overall total for each participant. The full version has been widely used among adolescent and AI populations, including Apache youth. |
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Aim 1
Inclusion Criteria:
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.
Exclusion Criteria:
• 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.
Aim 3
Inclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Mary Cwik, PhD | Johns Hopkins Bloomberg School of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Center for American Indian Health | Whiteriver | Arizona | 85941 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31830933 | Derived | O'Keefe VM, Haroz EE, Goklish N, Ivanich J; Celebrating Life Team; Cwik MF, Barlow A. Employing a sequential multiple assignment randomized trial (SMART) to evaluate the impact of brief risk and protective factor prevention interventions for American Indian Youth Suicide. BMC Public Health. 2019 Dec 12;19(1):1675. doi: 10.1186/s12889-019-7996-2. |
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N=284 participants completed baseline data and were randomized to the study arms. The participants who were not randomized were marked lost to follow-up if staff could not contact them further, or withdrawn if they requested to withdraw from the study.
N=304 participants were consented, N=284 completed baseline
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| ID | Title | Description |
|---|---|---|
| FG000 | New Hope (NH) | Participants Receive New Hope and Case Management |
| FG001 | Elders' Resilience (ER) | Participants Receive Elders' Resilience Curriculum and Case Management |
| FG002 | New Hope (NH) + Elders' Resilience (ER) + Case Management | Participants Receive New Hope, Elders' Resilience Curriculum and Case Management |
| FG003 | Case Management (CM) | Case Management alone |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 10-24 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Centers for Epidemiologic Studies of Depression (CESDR-10) | The Centers for Epidemiologic Studies of Depression (CESDR-10) is a self-report scale used to measure depressive symptoms (Cronbach's alpha ranged from 0.90 to 0.91 in a validation study). Scores on the CESDR-10 range from 0 (minimum) to 40 (maximum) with higher scores representing higher frequency of experiencing depression symptoms. CESDR-10 score is summed to provide an overall total for each participant. The full version has been widely used among adolescent and AI populations, including Apache youth. | Participants with data collected | Posted | Median | Inter-Quartile Range | score on a scale | Baseline, 30 days, 60 days, 90 days, 180 days |
|
from enrollment until end of follow-up, 6 months
AEs could be reported to study staff during study visits with participants, in alerts from the ER or hospital, or alerts from participant or family members outside of study visits. AEs were then recorded by the study team and reported to IRB and sponsor as required.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 10-24 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ER Treatment for Suicide Ideation | Psychiatric disorders | Systematic Assessment | Participant seen in ER for SI, discharged home |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Incarceration | General disorders | Systematic Assessment | Participant incarcerated |
Study limitations include constraints on generalizability, as our sample was predominantly female (73%) and conducted within a single Tribal Nation, limiting the generalizability of our findings. The study design did not permit isolation of the specific effects of case management alone; this was intentional and ethically necessary. The pandemic fundamentally compromised ERC implementation, and the intervention's full potential should be evaluated in a future study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mary Cwik | Johns Hopkins University | (410) 960-9503 | mcwik1@jhu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 3, 2023 | Nov 25, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Adult Informed Consent | Feb 3, 2023 | Nov 25, 2025 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Parent Informed Consent | Feb 3, 2023 | Nov 25, 2025 | ICF_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: Youth Informed Assent | Feb 3, 2023 | Nov 25, 2025 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D013405 | Suicide |
| D000092862 | Psychological Well-Being |
| D019966 | Substance-Related Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D010549 | Personal Satisfaction |
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| ID | Term |
|---|---|
| D019090 | Case Management |
| ID | Term |
|---|---|
| D010347 | Patient Care Planning |
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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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.
|
| New Hope (NH), Elders' Resiliency (ER), Case Management (CM) | Experimental | 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. |
|
|
| Elders Resilience (ER) | Behavioral | Elders' Resiliency is a monthly manualized curriculum taught by Elders in the community intended to bolster Apache youths' resilience to suicide ideation, attempts and substance abuse by promoting Apache cultural identity and values, youth's self-worth and role in the community, and fostering connectedness to society and community, with an emphasis on extended family as a nexus of strength. Each lesson introduces youth to cultural knowledge, stories, and songs with an emphasis on respect and the sacredness of each life. Our community-based Apache staff will select Elders who both express an interest in the current project and have demonstrated affinity and skill for teaching the current curriculum in the schools. After this group of Elders is recruited and agree to participate, they will be paired with our paraprofessional Apache study staff. |
|
| Case Management (CM) | Other | Research Program Assistants, who are trained Surveillance System Staff, will conduct the monitoring and case management visits in participants' homes or other private settings at baseline, 1, 2, 3 and 6 months post-enrollment. The CM visit includes rapport-building, use of the Suicide Ideation Questionnaire (SIQ) to assess imminent risk, and if youth report not yet having connected to services, referral to Apache Behavioral Health Services (ABHS), the local community mental health center. At CM visits, the Research Program Assistants will also monitor participants' completion of the study battery, which will be self-administered using tablets. In addition, Research Program Assistants will score the SIQ before leaving the youth. If the SIQ reveals the participant is at imminent risk, Research Program Assistants will employ a protocol for rescue services, which involves triaging youth immediately to the ED for further assessment and care. |
|
| Baseline, 30 days, 60 days, 90 days, 180 days |
| The Children's Hope Scale (CHS) | Children's Hope Scale, a 6-item measure assessing goal-directed thinking and pathways to achieve goals. Items are rated on a 6-point Likert scale (0=None of the time to 5=All of the time). Scoring Method: The total Hope Score is calculated by summing all 6 items. Score Range: 0 to 30 Interpretation:
| Baseline, 30 days, 60 days, 90 days, 180 days |
| Multicultural Mastery Scale | Multicultural Mastery Scale, an adapted version measuring problem-solving through social networks across three domains: Mastery-Friends (4 items), Mastery-Family (4 items), and Mastery-Self (5 items), totaling 13 items. Items were assessed using either a slider scale (0-100) recoded to a 5-point scale, or a 3-point scale (0=Not at all, 1=Somewhat, 2=A lot) rescaled to a 5-point format. The final scoring uses a 5-point scale where each item ranges from 0 to 4. Scoring Method: The total Communal Mastery Score is calculated by summing all 13 items. Score Range: 0 to 52 Interpretation:
| Baseline, 30 days, 60 days, 90 days, 180 days |
| Rosenberg Self Esteem Scale | The scale ranges from 0-30. Scores between 15 and 25 are within normal range; scores below 15 suggest low self-esteem. | Baseline, 30 days, 60 days, 90 days, 180 days |
| Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) Risk Score | The World Health Organization (WHO) Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) is a questionnaire that screens for all levels of problem or risky substance use in adults. A risk score can be provided for each substance, and scores are grouped into low risk (0-10 for alcohol), moderate risk (11-26 for alcohol) or high risk (27 or higher for alcohol). The score range is 0-39. Higher score worse risk. | Baseline, 30 days, 60 days, 90 days, 180 days |
| BG001 | 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 10-24 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). |
| BG002 | 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 10-24 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. |
| BG003 | 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 10-24 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. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | 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). |
| OG002 | 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. |
| OG003 | 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. |
|
|
| Secondary | The Children's Hope Scale (CHS) | Children's Hope Scale, a 6-item measure assessing goal-directed thinking and pathways to achieve goals. Items are rated on a 6-point Likert scale (0=None of the time to 5=All of the time). Scoring Method: The total Hope Score is calculated by summing all 6 items. Score Range: 0 to 30 Interpretation:
| Participants with data collected | Posted | Mean | Standard Deviation | units on a scale | Baseline, 30 days, 60 days, 90 days, 180 days |
|
|
|
| Secondary | Multicultural Mastery Scale | Multicultural Mastery Scale, an adapted version measuring problem-solving through social networks across three domains: Mastery-Friends (4 items), Mastery-Family (4 items), and Mastery-Self (5 items), totaling 13 items. Items were assessed using either a slider scale (0-100) recoded to a 5-point scale, or a 3-point scale (0=Not at all, 1=Somewhat, 2=A lot) rescaled to a 5-point format. The final scoring uses a 5-point scale where each item ranges from 0 to 4. Scoring Method: The total Communal Mastery Score is calculated by summing all 13 items. Score Range: 0 to 52 Interpretation:
| Participants with data collected | Posted | Mean | Standard Deviation | units on a scale | Baseline, 30 days, 60 days, 90 days, 180 days |
|
|
|
| Secondary | Rosenberg Self Esteem Scale | The scale ranges from 0-30. Scores between 15 and 25 are within normal range; scores below 15 suggest low self-esteem. | Participants with data collected | Posted | Mean | Standard Deviation | score on a scale | Baseline, 30 days, 60 days, 90 days, 180 days |
|
|
|
| Secondary | Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) Risk Score | The World Health Organization (WHO) Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) is a questionnaire that screens for all levels of problem or risky substance use in adults. A risk score can be provided for each substance, and scores are grouped into low risk (0-10 for alcohol), moderate risk (11-26 for alcohol) or high risk (27 or higher for alcohol). The score range is 0-39. Higher score worse risk. | Restricted to participants who reported alcohol use at baseline. This outcome measures reduction in existing alcohol use among current users. Non-users were excluded as the intervention targets harm reduction rather than prevention of initiation. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline, 30 days, 60 days, 90 days, 180 days |
|
|
|
| Primary | Suicide Ideation Questionnaire (SIQ) | 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:
| Participants with data collected | Posted | Median | Inter-Quartile Range | Z-score | Baseline, 30 days, 60 days, 90 days, 180 days |
|
|
|
| Primary | The Resiliency Scales | 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):
Interpretation:
| Participants with data collected | Posted | Mean | Standard Deviation | Units on a scale | Baseline, 30 days, 60 days, 90 days, 180 days |
|
|
|
| 0 |
| 71 |
| 15 |
| 71 |
| 5 |
| 71 |
| EG001 | 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 10-24 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). | 0 | 68 | 10 | 68 | 1 | 68 |
| EG002 | 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 10-24 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. | 0 | 65 | 10 | 65 | 0 | 65 |
| EG003 | 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 10-24 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. | 0 | 80 | 15 | 80 | 4 | 80 |
|
| In-patient treatment for SI | Psychiatric disorders | Systematic Assessment | Participant sent to in-patient treatment for SI |
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| Other hospitalization | General disorders | Systematic Assessment | not-mental health related visit to ER or hospital |
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| Expelled from school | General disorders | Systematic Assessment |
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| Sexual abuse | General disorders | Systematic Assessment | abuse/assault of participant, reported to study team and reported to BIA |
|
Not provided
Not provided
| D064419 |
| Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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