Native-RISE for Suicide Prevention

Enrolling by invitation at 2 trial locations

Overseen By Emily Haroz, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins Bloomberg School of Public Health

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new strategy called Native-RISE, a suicide prevention program designed to help prevent suicide among Native Americans through predictive analytics and brief interventions. The researchers aim to evaluate the effectiveness of this approach within three health clinics already focused on suicide prevention. The trial includes various groups, testing combinations of algorithm-based risk assessment and provider notifications. Individuals visiting one of these clinics and identified as at risk of suicide may be suitable candidates for the trial. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could significantly impact suicide prevention strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Native-RISE strategy is safe for suicide prevention?

Research shows that Native-RISE offers a new approach to preventing suicide. It employs data analysis to predict outcomes and uses short contact interventions to identify and manage suicide risk among Native Americans. Although specific safety data for Native-RISE is not available, the study is in a "Not Applicable" phase, focusing on strategies and processes rather than testing a new drug or device.

Since Native-RISE is neither a drug nor an invasive treatment, it is less likely to cause the usual side effects associated with medications. Instead, it aims to enhance mental health support through existing health systems. Thus, the risks relate more to the program's implementation rather than direct physical side effects.

Overall, while specific safety data for Native-RISE is unavailable, its design as a supportive system suggests a low risk for negative effects. Participants should feel free to ask the study team questions to understand how the program works and any potential impacts. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Native-RISE protocol for suicide prevention because it harnesses the power of advanced algorithms and real-time risk notifications to tackle mental health challenges in a novel way. Unlike traditional methods that rely on retrospective data or self-reporting, this approach uses algorithm-driven insights to identify individuals at high risk for suicide ideation, attempts, binge substance use, or self-injury, allowing for immediate intervention. By integrating technology with direct notifications to healthcare providers, Native-RISE aims to significantly enhance the responsiveness and effectiveness of care for those in critical need. This proactive, data-driven strategy could lead to substantial improvements in suicide prevention outcomes.

What evidence suggests that this trial's treatments could be effective for suicide prevention?

Research has shown that Native-RISE could be a powerful tool in preventing suicide among Native American communities. This trial evaluates different approaches using Native-RISE, including case managers with algorithm support and provider risk notifications. It combines data analysis to predict who might be at risk with short, supportive interactions to assist those individuals. Studies indicate that this approach can improve care and lead to better outcomes in communities with high suicide rates. Native Americans face suicide rates 3.5 times higher than the general population, highlighting the need for effective solutions like Native-RISE. If successful, this method could expand to Indian Health Service clinics, enhancing suicide prevention services for these communities. ^{1 2 3 4 6}

Who Is on the Research Team?

Emily Haroz, PhD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for Native American adults aged 18-75 who visit one of three IHS clinics and are identified as at risk of suicide by current methods or the new Native-RISE algorithm. There are no specific exclusion criteria.

Inclusion Criteria

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

Not applicable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive predictive analytics and brief contact interventions (BCIs) to reduce suicide risk

12 months

At least 3 contacts with Case Managers

Follow-up

Participants are monitored for safety and effectiveness after intervention

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Native-RISE

Trial Overview Native-RISE aims to reduce suicides among Native Americans by combining predictive analytics with brief contact interventions (BCIs) in a systems-level strategy, tested across three IHS health care clinics.

How Is the Trial Designed?

Group I: Case Managers WITH algorithm AND with provider risk notification (SI/SA/Binge/NSSI) Experimental Treatment 1 Intervention

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 II: Case Managers WITH algorithm AND provider risk notification (high risk history, no SI/SA/Binge/NSSI Experimental Treatment 1 Intervention

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

Group III: Provider risk notification alone (high risk history, without SI/SA/Binge/NSSI) Active Control 1 Intervention

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

Group IV: Case Managers withOUT algorithm AND with provider risk notification (SI/SA/Binge/NSSI) Active Control 1 Intervention

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).

Who Is Running the Clinical Trial?

Johns Hopkins Bloomberg School of Public Health

Lead Sponsor

Trials

441

Recruited

2,157,000+

Published Research Related to This Trial

A qualitative study involving experienced suicide researchers revealed significant challenges in defining and reporting adverse events (AEs) and serious adverse events (SAEs) in suicide prevention trials, which complicates safety evaluations.

Participants emphasized the urgent need for clear and consistent definitions and reporting standards for AEs and SAEs to improve the comparability of studies and enhance safety monitoring in at-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variability in the definition and reporting of adverse events in suicide prevention trials: an examination of the issues and a proposed solution. Oquendo, MA., Feldman, S., Silverman, E., et al.[2022]

A pharmacovigilance analysis of over 85,000 cases from the FDA's Adverse Event Reporting System identified specific drug combinations and indications that may increase the risk of suicide, highlighting the complexity of suicide risk factors.

The study suggests that certain demographic groups may be more affected by these drug combinations, indicating a need for further research to validate these findings and improve suicide prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mining Drugs and Indications for Suicide-Related Adverse Events. Ding, T., Chen, ES.[2020]

The study analyzed adverse events related to suicidality in 9 randomized placebo-controlled trials of duloxetine, revealing that while suicides were clearly identifiable, suicidal ideation and preparatory behaviors were often obscured due to the limitations of the medical coding dictionaries used, particularly COSTART.

The findings suggest that adverse event data in clinical study reports may not fully represent patient experiences, highlighting the importance of using detailed narratives and individual patient listings to capture a more accurate picture of potential harms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coding of adverse events of suicidality in clinical study reports of duloxetine for the treatment of major depressive disorder: descriptive study. Maund, E., Tendal, B., Hróbjartsson, A., et al.[2023]

In a study of 191 individuals hospitalized for suicide attempts, those receiving usual treatment plus a telephone follow-up program (TAU + T) showed a lower recurrence of suicide attempts compared to those receiving usual treatment alone (TAU).

Overall, 31.4% of participants attempted suicide again within a year, but the follow-up program appeared to help reduce this risk, particularly for those with a history of previous attempts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychiatric Hospitalization for Attempted Suicide and Reattempt at the One-Year Follow-Up. Goñi-Sarriés, A., Yárnoz-Goñi, N., López-Goñi, JJ.[2022]

The Caring Contacts intervention, a suicide prevention program, showed high acceptability among American Indian/Alaska Native (AI/AN) communities, with 92% of participants reporting a positive experience during initial assessments.

Adaptations made during the study's Phase 1, such as broadening eligibility criteria and incorporating locally-informed methods of self-harm, significantly increased participant recruitment and allowed for a more comprehensive understanding of suicidal behaviors in these communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Keep up the messages, sometimes it was a lifesaver": Effects of cultural adaptation on a suicide prevention clinical trial in American Indian/Alaska Native communities. Bogic, M., Hebert, LE., Evanson, A., et al.[2023]

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/11047729

NATIVE RISE-Risk Identification for Suicide and Enhanced ... If results are achieved, NATIVE-RISE will become an effective and scalable approach that improves services to prevent suicide among NA populations and ...

2. cih.jhu.edu cih.jhu.edu/programs/native-rise/

Native-RISE – Risk Identification for Suicide and Enhanced ... Native Americans experience suicide rates that are 3.5 times higher than the general population, a disparity that has worsened during the COVID-19 pandemic.

3. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/2804648

Risk Identification for Suicide and Enhanced Care Model in ... This cohort study evaluates the association of use of a statistical model to evaluate suicide risk with improvements in evidence-based care ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06782516

Native-RISE (Risk Identification for Suicide and Enhanced ... This project aims to prove the effectiveness and scalability of Native-RISE within three Indian Health Service (IHS) health care clinics (Whiteriver, Chinle and ...

5. northwell.edu northwell.edu/news/the-latest/helping-native-communities-among-rising-suicide-rates

Helping Native communities amid rising suicide rates It found that 3 in 4 respondents agreed telehealth was effective in suicide prevention. Nearly all (98%) said telehealth was needed. The ...

6. withpower.com withpower.com/trial/phase-suicide-prevention-3-2025-94c85

Native-RISE for Suicide Prevention · Info for Participants What safety data exists for Native-RISE or similar treatments in humans? The research highlights challenges in defining and reporting adverse events ...