ER + NH + CM Interventions for Suicide Prevention

Overseen By Victoria O'Keefe, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins Bloomberg School of Public Health

Disqualifiers: Severe medical, psychiatric, drug problems, others

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

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to identify the best combination of treatments to reduce suicidal thoughts and build resilience among American Indian youth. Participants will receive different combinations of three treatments: New Hope, Elders Resilience, and Case Management (also known as Geriatric Case Management or CM). The researchers seek to determine which treatment plan most effectively addresses suicidal ideation and resilience over time. The trial seeks American Indian youth aged 10 to 24 who have recently experienced suicidal thoughts, a suicide attempt, or binge substance use with suicidal thoughts.

As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could significantly improve mental health support for American Indian youth.

Do I have to stop taking my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the treatments under study are likely safe. For the Elders' Resilience program, studies indicate that resilience-focused approaches can help reduce depression, a major factor in suicide risk among older adults. This suggests the program is generally well-received and can help lessen suicidal thoughts.

The New Hope program teaches skills like managing emotions and changing negative thoughts to lower suicide risk. Early results from similar programs show these methods effectively reduce suicidal thoughts and are generally safe for participants.

Past research demonstrated that Case Management lowered the risk of death from repeated suicide attempts by 75%. This suggests it is a strong and safe option for those at risk, helping to delay and prevent further suicidal actions.

Overall, these programs are well-received and show positive results in reducing suicide risk, with no major negative effects reported in these studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these interventions for suicide prevention because they combine innovative approaches tailored to the needs of Native American youth. Unlike standard treatments which often focus solely on therapy or medication, these interventions integrate cultural resilience-building with case management. The Elders' Resilience program leverages cultural wisdom and community support, while New Hope focuses on personal empowerment and recovery. This multifaceted strategy aims to not only reduce suicidal thoughts but also strengthen overall mental well-being, offering a more holistic and potentially more effective solution compared to traditional methods.

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

Research has shown that the New Hope program, one of the interventions in this trial, can greatly reduce suicidal thoughts in participants compared to using case management alone. Specifically, adding New Hope to case management has led to a noticeable drop in these thoughts. Meanwhile, the Elders Resilience intervention, another treatment arm in this trial, helps participants become more resilient, enabling better recovery from challenges. Studies have found that this approach can significantly lower suicidal thoughts over time. Case management by itself, also a treatment arm in this trial, is effective; research has shown it can reduce the risk of attempting suicide again by 75% and lower the overall risk of suicide. Each of these treatments offers unique benefits for supporting young people at risk. ^{2 3 6 7 8}

Who Is on the Research Team?

Mary Cwik, PhD

Principal Investigator

Johns Hopkins Bloomberg School of Public Health

Are You a Good Fit for This Trial?

This trial is for Native American youth aged 10-24 living near the Fort Apache Indian Reservation, who have had suicidal thoughts or behaviors, or substance use issues in the last 3 months. Participants under 18 need parental consent. Those with recent suicide attempts are also eligible.

Inclusion Criteria

The study uses specific definitions to classify certain behaviors related to suicide. If you have intentionally hurt yourself with the intention of ending your life, have had thoughts of taking your own life, or have recently used drugs or alcohol in a harmful way while experiencing suicidal thoughts, you may not be eligible for the study.

You have had thoughts of suicide, have recently engaged in heavy drug or alcohol use along with thoughts of suicide within the last 3 months, or have attempted suicide in the past 30 days.

I am a Native American between 10 and 24 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline and Initial Randomization

Youth complete baseline assessment and are randomized to New Hope plus Case Management or Case Management alone

1 day

1 visit (in-person)

First Treatment Phase

Participants receive New Hope intervention plus Case Management or Case Management alone, followed by assessment after 30 days

4 weeks

1 visit (in-person) for assessment

Second Treatment Phase

Participants are re-randomized to Elders' Resilience intervention plus Case Management or Case Management alone, followed by assessment after another 30 days

4 weeks

1 visit (in-person) for assessment

Follow-up

Participants are monitored for long-term outcomes, including suicidal ideation and resilience, with a final assessment 6 months post-enrollment

3 months

1 visit (in-person) for final assessment

What Are the Treatments Tested in This Trial?

Interventions

• Case Management
• Elders Resilience
• New Hope

Trial Overview The study tests sequences of three interventions: New Hope (NH), Elders Resilience (ER), and Case Management (CM) to see which combination best reduces suicidal thoughts and increases resilience in at-risk American Indian adolescents.

How Is the Trial Designed?

Group I: New Hope (NH), Elders' Resiliency (ER), Case Management (CM) Experimental Treatment 3 Interventions

The investigators will employ a SMART design to evaluate the effectiveness of New Hope (NH), Elders' Resilience intervention (ER), Case Management (CM) and the combination of these approaches on reducing suicidal thoughts and promoting resilience among AI youth ages 10-24 who are confirmed by surveillance case managers to have recently experienced suicide ideation, attempt or a binge substance use and ideation. Youth who assent will complete the baseline (CM visit 1 and will be referred to mental health care). During the same visit, youth will be randomized 1:1 to either New Hope (NH) plus Case Management (CM), or CM alone, using a blocked randomized design, stratifying participants by age and event type. All youth will complete another study assessment after 30 days.After another 30-days, all participants will be re-assessed/re-randomized, using the same blocking and 1:1 ratio to either the ER intervention plus CM, or CM alone.

Group II: New Hope (NH) Experimental Treatment 2 Interventions

The investigators will employ a SMART design to evaluate the effectiveness of New Hope (NH), Elders' Resilience intervention (ER), Case Management (CM) and the combination of these approaches on reducing suicidal thoughts and promoting resilience among AI youth ages 10-24 who are confirmed by surveillance case managers to have recently experienced suicide ideation, attempt or a binge substance use and ideation. Youth who assent will complete the baseline (CM visit 1 and will be referred to mental health care). During the same visit, youth will be randomized 1:1 to either New Hope (NH) plus Case Management (CM), or CM alone, using a blocked randomized design, stratifying participants by age and event type.

Group III: Elders' Resiliency (ER) Experimental Treatment 2 Interventions

The investigators will employ a SMART design to evaluate the effectiveness of New Hope (NH), Elders' Resilience intervention (ER), Case Management (CM) and the combination of these approaches on reducing suicidal thoughts and promoting resilience among AI youth ages 10-24 who are confirmed by surveillance case managers to have recently experienced suicide ideation, attempt or a binge substance use and ideation. All youth will complete another study assessment after 30 days. The 30-day time frame will allow ample time to complete the NH intervention with participants and assess any changes in youth's mental health status for all study arms. Following another 30-day period, all participants will be re-assessed and re-randomized, using the same blocking and 1:1 ratio to either the Elders' Resilience (ER) intervention plus CM, or CM alone. To track long term outcomes, all youth will complete a final assessment 3 month later (6 months post-enrollment).

Group IV: Control Condition Experimental Treatment 1 Intervention

The control condition will only receive Case Management (CM) (n=76). The investigators will employ a SMART design to evaluate the effectiveness of New Hope (NH), Elders' Resilience intervention (ER), Case Management (CM) and the combination of these approaches on reducing suicidal thoughts and promoting resilience among AI youth ages 10-24 who are confirmed by surveillance case managers to have recently experienced suicide ideation, attempt or a binge substance use and ideation. Youth who assent will complete the baseline (CM visit 1 and will be referred to mental health care). During the same visit, youth will be randomized 1:1 to either New Hope (NH) plus Case Management (CM), or CM alone, using a blocked randomized design, stratifying participants by age and event type.

Case Management is already approved in United States for the following indications:

Approved in United States as Case Management for:

• Hoarding Disorder

Who Is Running the Clinical Trial?

Johns Hopkins Bloomberg School of Public Health

Lead Sponsor

Trials

441

Recruited

2,157,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3728773/

A Systematic Review of Elderly Suicide Prevention Programs Results showed that, after 24 months, decline in suicidal ideation was 2.1 times greater [0.8–5.5] in the intervention group (16.9%; at baseline, 29.7%) than in ...

2. mdpi.com mdpi.com/1660-4601/17/7/2599

Effectiveness of a Flexible and Continuous Case ... Our results indicated that the case management program reduced the risk of death from suicide reattempts by 75% and delayed the time to death from suicide ...

3. cmsatoday.com cmsatoday.com/2025/02/18/suicide-and-older-adults-risk-factors-and-best-practices-for-case-managers/

Suicide and Older Adults: Risk Factors and Best Practices for ... According to Shah et al (2022), “[V]arious studies have shown that interventions such as diet improvements, cognitive training, psychosocial ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0735675718309963

The effects of case management program completion on ... Participants who completed the case management program were more likely to have decreased suicide risk (65.3% vs. 46.9%, AOR: 2.13 (1.42–3.20)) and less ...

5. researchgate.net researchgate.net/publication/389215149_Case_management_for_suicide_prevention_a_rapid_review_and_evidence_map

Case management for suicide prevention: a rapid review ... Participants who completed the case management program were more likely to have decreased suicide risk (65.3% vs. 46.9%, AOR: 2.13 (1.42-3.20)) ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8363358/

Suicide prevention strategies for older persons—An ... The findings indicate an urgent need to identify effective suicide prevention strategies for older adults.

7. dphhs.mt.gov dphhs.mt.gov/suicideprevention/toolkit/olderpopulation

Addressing Suicide in the Older Population Research has shown that older adults have the highest rate of suicide compared to any other group. Additionally, older adults are more likely to die from a ...

8. researchgate.net researchgate.net/publication/286445768_Geriatric_Case_Managers'_Perspectives_on_Suicide_Among_Community-Dwelling_Older_Adults

Geriatric Case Managers' Perspectives on Suicide Among ... Results indicated that 38% of respondents reported they had, since CALM training, discussed reducing access to lethal means with clients and/or ...