Southwest Hub for American Indian Youth Suicide Prevention Research

NCT03543865 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 304

Last updated 2026-01-23

Study results available
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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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH
  • Johns Hopkins Bloomberg School of Public Health

    lead OTHER

Principal Investigators

  • Mary Cwik, PhD · Johns Hopkins Bloomberg School of Public Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
16 Years
Max Age
29 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-25
Primary Completion
2024-11-30
Completion
2024-11-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03543865 on ClinicalTrials.gov