Suicide PreventionNCT06782516
Native-RISE (Risk Identification for Suicide and Enhanced Care)
A study testing System of Care - combination of algorithm and Brief Contact Intervention and Active Comparator - Provider notification of risk status in people with Suicide Prevention, run by Johns Hopkins Bloomberg School of Public Health at 3 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Suicide Prevention
- What is being tested?
- System of Care - combination of algorithm and Brief Contact Intervention and Active Comparator - Provider notification of risk status
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,687 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Dec 2024to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
Chinle Navajo Nation Center for Indigenous Health
Chinle, Arizona, 86503
Shiprock Center for Indigenous Health
Shiprock, New Mexico, 87420
Whiteriver Center for Indigenous Health
Whiteriver, Arizona, 85941
About this study
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).
- Conditions
- Suicide Prevention
- Being tested
- System of Care - combination of algorithm and Brief Contact Intervention, Active Comparator - Provider notification of risk status
- Medical subject headings
- Suicide Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
System of Care - combination of algorithm and Brief Contact InterventionDevice
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 notification of risk statusBehavioural
Clinical Providers receive a risk notification and a resource card is provided to the participant.
| Study group | Role | What they receive |
|---|---|---|
| Case Managers WITH algorithm AND with provider risk notification (SI/SA/Binge/NSSI) | Experimental | 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). Receives: Device: System of Care - combination of algorithm and Brief Contact Intervention |
| Case Managers withOUT algorithm AND with provider risk notification (SI/SA/Binge/NSSI) | Active comparator | 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). Receives: Behavioral: Active Comparator - Provider notification of risk status |
| Case Managers WITH algorithm AND provider risk notification (high risk history, no SI/SA/Binge/NSSI | Experimental | Case Managers who see the algorithm classification + provider risk notification; participants get resource card distribution. High risk participants based on algorithm classification. Receives: Device: System of Care - combination of algorithm and Brief Contact Intervention |
| Provider risk notification alone (high risk history, without SI/SA/Binge/NSSI) | Active comparator | Provider risk notification alone; participants get resource card distribution. High risk participants based on algorithm classification. Receives: Behavioral: Active Comparator - Provider notification of risk status |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start1 Dec 2024
- Primary completion30 Sep 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Suicide PreventionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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 \[0.61-0.67\]).
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 1,687 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emily Haroz, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06782516
- Sponsor's protocol ID
- IRB00026145
- Status last verified
- Jan 2026
- First submitted
- 15 Jan 2025
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 39401036Adams 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Native-RISE (Risk Identification for Suicide and Enhanced Care)
- ClinicalTrials.gov ID
- NCT06782516
- Acronym / sponsor ID
- IRB00026145
- Conditions
- Suicide Prevention
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,687 participants (estimated)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 20 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 4
- Model description
- 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]).
| Arm | Type | Receives |
|---|---|---|
| Case Managers WITH algorithm AND with provider risk notification (SI/SA/Binge/NSSI) | Experimental | Device: System of Care - combination of algorithm and Brief Contact InterventionCase 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). |
| Case Managers withOUT algorithm AND with provider risk notification (SI/SA/Binge/NSSI) | Active comparator | Behavioral: Active Comparator - Provider notification of risk statusCase 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). |
| Case Managers WITH algorithm AND provider risk notification (high risk history, no SI/SA/Binge/NSSI | Experimental | Device: System of Care - combination of algorithm and Brief Contact InterventionCase Managers who see the algorithm classification + provider risk notification; participants get resource card distribution. High risk participants based on algorithm classification. |
| Provider risk notification alone (high risk history, without SI/SA/Binge/NSSI) | Active comparator | Behavioral: Active Comparator - Provider notification of risk statusProvider risk notification alone; participants get resource card distribution. High risk participants based on algorithm classification. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| System of Care - combination of algorithm and Brief Contact InterventionCase managers see the Native-RISE algorithm classification and Clinical Providers receive a risk notification. A resource card is provided to the participant. | Device | Case Managers WITH algorithm AND provider risk notification (high risk history, no SI/SA/Binge/NSSI, Case Managers WITH algorithm AND with provider risk notification (SI/SA/Binge/NSSI) |
| Active Comparator - Provider notification of risk statusClinical Providers receive a risk notification and a resource card is provided to the participant. | Behavioural | Case Managers withOUT algorithm AND with provider risk notification (SI/SA/Binge/NSSI), Provider risk notification alone (high risk history, without SI/SA/Binge/NSSI) |
Primary outcome
Rate of suicide attempts among individuals flagged at elevated risk
Time frame: 12 months
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.
1 secondary outcome
Number of contacts with Case Managers (Reach of Brief Contact Interventions (BCI))
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Background: PubMed 39401036Haroz 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.
- Background: PubMed 39414996Adams 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emily Haroz, PhD principal investigator
Johns Hopkins University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing System of Care - combination of algorithm and Brief Contact Intervention and Active Comparator - Provider notification of risk status in people with Suicide Prevention, run by Johns Hopkins Bloomberg School of Public Health at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of suicide attempts among individuals flagged at elevated risk (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06782516, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.