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

NCT ID: NCT06782516

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

1687 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-01

Study Completion Date

2030-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Suicide Prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Native-RISE Model is a predictive algorithm for suicide risk in Native American populations. The algorithm was developed based on analysis of over 330,000 visits and designed to identify people at risk of a suicide attempt or death within 90 days of the last visit. The evaluation of the model initial results have been published with the model having an area under the ROC (AUROC) 0.83 \[0.80-0.86\]) and performing better than existing care (AUROC 0.64 \[0.61-0.67\]).
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Caregivers

Study Groups

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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).

Group Type EXPERIMENTAL

System of Care - combination of algorithm and Brief Contact Intervention

Intervention Type DEVICE

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

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).

Group Type ACTIVE_COMPARATOR

Active Comparator - Provider notification of risk status

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

System of Care - combination of algorithm and Brief Contact Intervention

Intervention Type DEVICE

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

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.

Group Type ACTIVE_COMPARATOR

Active Comparator - Provider notification of risk status

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type DEVICE

Active Comparator - Provider notification of risk status

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emily Haroz, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Chinle Navajo Nation Center for Indigenous Health

Chinle, Arizona, United States

Site Status

Whiteriver Center for Indigenous Health

Whiteriver, Arizona, United States

Site Status

Shiprock Center for Indigenous Health

Shiprock, New Mexico, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 39401036 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39414996 (View on PubMed)

Other Identifiers

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IRB00026145

Identifier Type: -

Identifier Source: org_study_id