Native-RISE for Suicide Prevention

Recruiting 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

1687 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Native-RISE for suicide prevention?

Research shows that suicide prevention programs that actively maintain contact with patients are more effective in reducing further suicide attempts. Additionally, community-based interventions like the Nuremberg Alliance Against Depression have significantly reduced suicidal acts, suggesting that structured, ongoing support can be beneficial. ^{1 2 3 4 5}

What safety data exists for Native-RISE or similar treatments in humans?

The research highlights challenges in defining and reporting adverse events (unwanted effects from treatment) in suicide prevention trials, which makes it hard to evaluate safety. However, a study on a similar intervention, Caring Contacts, showed high acceptability in American Indian/Alaska Native communities, suggesting it was well-received and considered safe by participants. ^{6 7 8 9 10}

How is the Native-RISE treatment for suicide prevention unique?

Native-RISE is unique because it incorporates culturally embedded approaches that are specifically designed for Native communities, focusing on indigenous values and community strengths to inspire hope and healing. ^{3 11 12 13 14}

What is the purpose of this trial?

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).

Research Team

Emily Haroz, PhD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. Spain pubmed.ncbi.nlm.nih.gov

Psychiatric Hospitalization for Attempted Suicide and Reattempt at the One-Year Follow-Up. [2022]

2. England pubmed.ncbi.nlm.nih.gov

An Emergency Department-Initiated Intervention to Lower Relapse Risk after Attempted Suicide. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Global systematic review of the effects of suicide prevention interventions in Indigenous peoples. [2021]

4. Germany pubmed.ncbi.nlm.nih.gov

[Results of a clinico-experimental evaluation of suicide prevention programs]. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Sustainable effects on suicidality were found for the Nuremberg alliance against depression. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Mining Drugs and Indications for Suicide-Related Adverse Events. [2020]

7. England 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. [2022]

8. England 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. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Suicide risk during antidepressant treatment. [2022]

10. England 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. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Advancing suicide prevention research with rural American Indian and Alaska Native populations. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Suicide mortality among American Indians and Alaska Natives, 1999-2009. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Hope, help, and healing: Culturally embedded approaches to suicide prevention, intervention and postvention services with native Hawaiian youth. [2022]

14. England pubmed.ncbi.nlm.nih.gov

Reaching Those at Highest Risk for Suicide: Development of a Model Using Machine Learning Methods for use With Native American Communities. [2022]