NCT03543865

Southwest Hub for American Indian Youth Suicide Prevention Research

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 304 (actual)
• Sponsor: Johns Hopkins Bloomberg School of Public Health · Academic / Other
• Sex: All
• Age: 16 Years – 29 Years
• Healthy volunteers: Accepted

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.

Conditions

• Suicide
• Surveillance
• Mental Health
• Substance Use
• Depressive Symptoms

Interventions

Type	Name	Description
BEHAVIORAL	New 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.
BEHAVIORAL	Elders 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.
OTHER	Case 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.

Timeline

• Start date: 2019-03-25
• Primary completion: 2024-11-30
• Completion: 2024-11-30
• First posted: 2018-06-01
• Last updated: 2026-01-23
• Results posted: 2026-01-23

Locations

1 site across 1 country: United States