Depressive Symptoms, Mental Health, Substance Use, Suicide, Surveillance
Conditions
Keywords
American Indian, Resilience, Native American
Brief summary
1. 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.
Detailed description
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.
Interventions
BEHAVIORALNew Hope (NH)
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.
BEHAVIORALElders Resilience (ER)
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.
OTHERCase Management (CM)
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.
Sponsors
Johns Hopkins Bloomberg School of Public Health
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 29 Years
Healthy volunteers
Yes
Inclusion criteria
Aim 1 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.
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: * Youth over the age of 16 or adults over the age of 18. * A person with an interest or concern related to youth suicide among AI populations.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Suicide Ideation Questionnaire (SIQ) | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Centers for Epidemiologic Studies of Depression (CESDR-10) | Baseline, 30 days, 60 days, 90 days, 180 days | 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. |
| The Children's Hope Scale (CHS) | Baseline, 30 days, 60 days, 90 days, 180 days | 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: * Higher scores indicate greater hope (better outcome) * Lower scores indicate lower hope (worse outcome) |
| Multicultural Mastery Scale | Baseline, 30 days, 60 days, 90 days, 180 days | 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: * Higher scores indicate a stronger sense of mastery and control (better outcome) * Lower scores indicate lower mastery (worse outcome) |
| Rosenberg Self Esteem Scale | Baseline, 30 days, 60 days, 90 days, 180 days | The scale ranges from 0-30. Scores between 15 and 25 are within normal range; scores below 15 suggest low self-esteem. |
| Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) Risk Score | Baseline, 30 days, 60 days, 90 days, 180 days | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMary Cwik, PhD
Johns Hopkins Bloomberg School of Public Health
Participant flow
Recruitment details
N=304 participants were consented, N=284 completed baseline
Pre-assignment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized Age 14 and younger | 132 Participants |
| Age, Customized Age 15-19 | 19 Participants |
| Age, Customized Age 20-24 | 52 Participants |
| Age, Customized Age 25-29 | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 71 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex/Gender, Customized Sex Do not wish to disclose | 1 Participants |
| Sex/Gender, Customized Sex Female | 48 Participants |
| Sex/Gender, Customized Sex Male | 20 Participants |
| Sex/Gender, Customized Sex Missing | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 71 | 0 / 68 | 0 / 65 | 0 / 80 |
| other Total, other adverse events | 5 / 71 | 1 / 68 | 0 / 65 | 4 / 80 |
| serious Total, serious adverse events | 15 / 71 | 10 / 68 | 10 / 65 | 15 / 80 |
Outcome results
None listed