CClinicalTrials.gg
Enrolling by invitationNCT06782516Updated Feb 2, 2026

Native-RISE (Risk Identification for Suicide and Enhanced Care)

An interventional study of System of Care - combination of algorithm and Brief Contact Intervention and Active Comparator - Provider notification of risk status in Suicide Prevention, sponsored by Johns Hopkins Bloomberg School of Public Health. Enrolling by invitation at 3 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-02-02.

Sponsored by Johns Hopkins Bloomberg School of Public Health · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
1,687
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
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Study summary

The goal of this research is to test a systems-level suicide prevention strategy, Native-RISE (Risk Identification for Suicide and Enhanced care), that combines predictive analytics and brief contact interventions (BCIs) to reduce suicide in health systems serving Native Americans (NAs). This project aims to prove the effectiveness and scalability of Native-RISE within three Indian Health Service (IHS) health care clinics (Whiteriver, Chinle and Shiprock) already implementing suicide prevention programs and serving the White Mountain Apache Tribe (WMAT) and Navajo Nation (NN).

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Conditions studied

  • Suicide Prevention

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03

In context

Suicide Prevention

190 studies on the registry are indexed under Suicide Prevention; 87 are open to participants now.

This study's planned enrollment of 1,687 is above the median of 150 across 169 interventional studies indexed under Suicide Prevention.

Browse Suicide Prevention studies →

Lead sponsor

Johns Hopkins Bloomberg School of Public Health is the lead sponsor of 364 studies on the registry; 41 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Adults aged 18-75
  • Visit at least one of the three participating IHS clinics
  • Identified as at risk of suicide by either an existing method or the new Native-RISE risk model algorithm

Exclusion criteria

Exclusion Criteria:

  • None
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Care provider)
Enrollment
1,687 participants (estimated)

Study arms

  • Experimental
    Case Managers WITH algorithm AND with provider risk notification (SI/SA/Binge/NSSI)

    Case Managers who see the algorithm classification + IHS provider risk notification \& resource card distribution. These participants present with suicide ideation (SI), suicide attempt (SA), binge substance use (Binge), or non-suicidal self injury (NSSI).

    Device: System of Care - combination of algorithm and Brief Contact Intervention

  • Active comparator
    Case Managers withOUT algorithm AND with provider risk notification (SI/SA/Binge/NSSI)

    Case Managers who do NOT see the algorithm classification + IHS provider risk notification \& resource card distribution. These participants present with suicide ideation (SI), suicide attempt (SA), binge substance use (Binge), or non-suicidal self injury (NSSI).

    Behavioral: Active Comparator - Provider notification of risk status

  • Experimental
    Case Managers WITH algorithm AND provider risk notification (high risk history, no SI/SA/Binge/NSSI

    Case Managers who see the algorithm classification + provider risk notification; participants get resource card distribution. High risk participants based on algorithm classification.

    Device: System of Care - combination of algorithm and Brief Contact Intervention

  • Active comparator
    Provider risk notification alone (high risk history, without SI/SA/Binge/NSSI)

    Provider risk notification alone; participants get resource card distribution. High risk participants based on algorithm classification.

    Behavioral: Active Comparator - Provider notification of risk status

Interventions

  • DeviceSystem of Care - combination of algorithm and Brief Contact Intervention

    Case managers see the Native-RISE algorithm classification and Clinical Providers receive a risk notification. A resource card is provided to the participant.

  • BehavioralActive Comparator - Provider notification of risk status

    Clinical Providers receive a risk notification and a resource card is provided to the participant.

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What researchers measure

Primary outcomes

  1. Rate of suicide attempts among individuals flagged at elevated risk

    Rate of suicide attempts among individuals flagged at elevated risk is tracked through International Classification of Diseases (ICD) codes and chief complaints as recorded in the participating health system.

    Time frame: 12 months

Secondary outcomes

  1. Number of contacts with Case Managers (Reach of Brief Contact Interventions (BCI))

    Reach of BCI is defined as at least three or more contacts with Case Managers within the first year following identification of elevated risk.

    Time frame: 12 months

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Study locations

3 sites
  • Chinle Navajo Nation Center for Indigenous Health
    Chinle, Arizona 86503, United States
  • Whiteriver Center for Indigenous Health
    Whiteriver, Arizona 85941, United States
  • Shiprock Center for Indigenous Health
    Shiprock, New Mexico 87420, United States
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References and documents

Publications

  • Haroz EE, Rebman P, Goklish N, Garcia M, Suttle R, Maggio D, Clattenburg E, Mega J, Adams R. Performance of Machine Learning Suicide Risk Models in an American Indian Population. JAMA Netw Open. 2024 Oct 1;7(10):e2439269. doi: 10.1001/jamanetworkopen.2024.39269. PubMed 39401036 ↗
  • Adams R, Haroz EE, Rebman P, Suttle R, Grosvenor L, Bajaj M, Dayal RR, Maggio D, Kettering CL, Goklish N. Developing a suicide risk model for use in the Indian Health Service. Npj Ment Health Res. 2024 Oct 16;3(1):47. doi: 10.1038/s44184-024-00088-5. PubMed 39414996 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06782516
Lead sponsor
Johns Hopkins Bloomberg School of Public Health
Responsible party
Sponsor
First posted
Jan 20, 2025
Start date
Dec 1, 2024
Primary completion
Sep 30, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Feb 2, 2026

Study contacts

Emily Haroz, PhD
principal investigator · Johns Hopkins University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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