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

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).

Study Overview

• Status: Enrolling by invitation
• Conditions: Suicide Prevention
• Intervention / Treatment: Device: System of Care - combination of algorithm and Brief Contact Intervention; Behavioral: Active Comparator - Provider notification of risk status

• Study Type: Interventional
• Enrollment (Estimated): 1687
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Chinle, Arizona, United States, 86503
      • Chinle Navajo Nation Center for Indigenous Health
    • Whiteriver, Arizona, United States, 85941
      • Whiteriver Center for Indigenous Health
  • New Mexico
    • Shiprock, New Mexico, United States, 87420
      • Shiprock Center for Indigenous Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Case managers see the Native-RISE algorithm classification and Clinical Providers receive a risk notification. A resource card is provided to the participant.
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; Clinical Providers receive a risk notification and a resource card is provided to the participant.
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; Case managers see the Native-RISE algorithm classification and Clinical Providers receive a risk notification. A resource card is provided to the participant.
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; Clinical Providers receive a risk notification and a resource card is provided to the participant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Collaborators and Investigators

• Sponsor: Johns Hopkins Bloomberg School of Public Health
• Investigators: Principal Investigator: Emily Haroz, PhD, Johns Hopkins University

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2024
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: January 15, 2025
• First Submitted That Met QC Criteria: January 15, 2025
• First Posted (Actual): January 20, 2025

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 29, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Behavior; Suicide Prevention
• Other Study ID Numbers: IRB00026145

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No