WeCare for Suicidal Thoughts

(WeCare Trial)

Overseen By Jacqueline Holloway, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: New York University

Disqualifiers: Medically unstable, Severe cognitive impairment, others

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

Compensation: Varies

Number of Visits: 4

2200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to find a better way to prevent suicide in Black youth by testing a new approach called WeCare. WeCare includes a computer-based screening tool, a brief safety planning session, and follow-up text support for six weeks after an emergency department visit. The trial will compare this new approach to the usual care that youth receive. Eligible participants are teens aged 12-19 who have a cell phone with text capabilities and are not currently in mental health treatment. This trial specifically targets those who visit the emergency department and can speak English, with parents or guardians who can consent in English, Spanish, French, or Creole. As an unphased trial, this study offers a unique opportunity to contribute to innovative solutions for youth suicide prevention.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are actively receiving mental health treatment, you may not be eligible to participate.

What prior data suggests that the WeCare system is safe for Black youth?

Research shows that the WeCare system is under careful study to assist Black youth at risk for suicide. The main goal is to ensure the system's safety and effectiveness. Previous studies have demonstrated that similar methods, such as the Collaborative Care Model, can reduce suicide risk by 52% in those identified as "at risk." This indicates that components of WeCare might be well-received.

The system includes screening, emergency department assistance, and follow-up support through text messages. These steps aim to support and connect young people to mental health services. Similar programs have reported no harm or negative effects from these methods, suggesting that WeCare is likely safe for participants. However, researchers will closely monitor the trial to ensure its safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the WeCare system because it offers a comprehensive approach to managing suicidal thoughts among youth. Unlike traditional treatments that may focus solely on therapy or medication, WeCare integrates universal screening, an emergency department-based intervention, and text message follow-ups to provide continuous support. This multi-faceted approach aims to identify at-risk individuals early and maintain engagement, potentially improving outcomes and reducing the risk of future crises.

What evidence suggests that the WeCare system of care is effective for preventing suicide among Black youth?

Research shows that the WeCare system, which participants in this trial may receive, aims to prevent suicide among Black youth using a three-part plan. Studies have found that similar methods, such as providing care in primary health settings, can reduce suicide attempts by 25% in just 90 days. The WeCare plan includes screening everyone to identify at-risk youth early, a brief intervention in emergency rooms, and follow-up support through text messages. This approach relies on strong evidence that early risk recognition and swift action can lower the chance of suicide. Additionally, collaborative care models have successfully reduced suicidal thoughts and improved mental health. ^{1 2 3 6 7}

Who Is on the Research Team?

Michael A Lindsey, PhD

Principal Investigator

New York University

Are You a Good Fit for This Trial?

This trial is for Black adolescents aged 12-19 who are experiencing suicidal thoughts and visit emergency departments. Participants must have a phone with texting, speak English, and be accompanied by consenting parents or guardians if under 18. It aims to help them through screening, a brief intervention tailored for Black youth in ED settings, and follow-up supportive texts.

Inclusion Criteria

Having a cellular phone with text messaging capacity

I am between 12-19 years old and may include my parent or guardian.

I am a teenager who speaks and understands English.

Exclusion Criteria

Adolescent is medically unstable

Adolescent does not have access to cellular phone

I have severe cognitive impairment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Intervention

Participants receive the WeCare intervention, which includes universal screening, ED-based intervention, and text message follow-up

6 weeks

1 visit (in-person), ongoing text message support

Follow-up

Participants are monitored for safety and effectiveness after the intervention, with survey assessments at 3 and 6 months

12 months

2 visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• WeCare

Trial Overview WeCare strategy is being tested which includes: (1) CASSY - a tool for suicide risk screening; (2) Connections for Safety (CFS), an ED-based intervention; and (3) six weeks of supportive text messages to the youth and their caregivers after the ED visit.

How Is the Trial Designed?

Group I: WeCare Experimental Treatment 1 Intervention

WeCare system of care - universal screening, ED-based intervention, text message follow-up.

Group II: Usual Services Active Control 1 Intervention

Usual care for youth presenting to the ED will be the control condition.

Who Is Running the Clinical Trial?

New York University

Lead Sponsor

Trials

249

Recruited

229,000+

University of Michigan

Collaborator

Trials

1,891

Recruited

6,458,000+

Published Research Related to This Trial

The pilot program, involving 108 patients (67.6% women) at risk for intimate partner violence (IPV), suicidality, and depression, demonstrated that peer support can effectively reduce symptoms of IPV and depression, as well as lower suicide risk over a 6-month period.

Participants who remained in the program showed significant declines in IPV, depression, and suicide risk scores, highlighting the efficacy of peer navigators in providing support and continuity of care for individuals with complex mental health needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Piloting a Peer Support Program for Patients Who Screen Positive for Intimate Partner Violence, Suicidal Ideation, and Depression. Drouin, M., Flanagan, M., Carroll, J., et al.[2023]

The 'Zero Suicide' initiative is a promising systems-level response to the high rates of suicide in healthcare settings, showing positive results in improving care for suicidal individuals.

The Collaborative Assessment and Management of Suicidality (CAMS) is an evidence-based intervention that can be effectively integrated into various levels of care, emphasizing a cost-effective and least-restrictive approach to suicide prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A stepped care approach to clinical suicide prevention. Jobes, DA., Gregorian, MJ., Colborn, VA.[2022]

In a randomized controlled trial with 148 U.S. Army Soldiers, the Collaborative Assessment and Management of Suicidality (CAMS) was found to significantly reduce suicidal ideation (SI) compared to enhanced care as usual (E-CAU) by 3 months, with a strong effect size (Cohen's d = 0.93).

Both CAMS and E-CAU led to improvements in various behavioral health outcomes, but CAMS showed a notable advantage in reducing suicidal thoughts, highlighting its potential as an effective intervention for Soldiers with significant suicidal ideation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Trial of the Collaborative Assessment and Management of Suicidality versus Enhanced Care as Usual With Suicidal Soldiers. Jobes, DA., Comtois, KA., Gutierrez, PM., et al.[2019]

Emphasizing early intervention and ongoing low-intensity contact with individuals at risk of suicide can be more effective than solely focusing on those deemed 'highest risk', suggesting a shift in treatment strategy.

The use of advanced interactive computer programs can enhance screening and training for healthcare providers, improving access to mental health services and continuity of care for suicidal individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suicide prevention in a treatment setting. Litman, RE.[2022]

The Zero Suicide model emphasizes the importance of health care systems in identifying and intervening with patients at risk of suicide, as 40% of individuals who die by suicide had visited primary care within a month prior.

There is a critical need for innovative approaches to engage and treat suicidal individuals, particularly males, who are less likely to seek help, and to develop suicide-specific psychosocial interventions for inpatient settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Need for Innovation in Health Care Systems to Improve Suicide Prevention. Stanley, B., Mann, JJ.[2022]

Caring Contacts, which are supportive text messages sent to military personnel at risk of suicide, showed a significant reduction in the odds of experiencing suicidal ideation and attempts compared to standard care, suggesting they may be a valuable addition to mental health interventions.

While the primary outcomes did not show significant effects, the secondary outcomes indicated that participants receiving Caring Contacts had lower rates of suicidal ideation and attempts, highlighting the potential of this low-cost intervention in preventing suicidality among military service members.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Augmenting Standard Care for Military Personnel With Brief Caring Text Messages for Suicide Prevention: A Randomized Clinical Trial. Comtois, KA., Kerbrat, AH., DeCou, CR., et al.[2022]

In a study of 1547 youths aged 11 to 20, 14% reported suicidal thoughts, highlighting the importance of screening in primary care settings, especially among vulnerable groups like girls and those with behavioral issues.

The implementation of a computerized screening process and a coordinated mental health team allowed for rapid triage and referral, with 65% of referred youths receiving mental health services within 6 months, demonstrating the effectiveness of this approach in connecting at-risk youths to necessary care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening, triage, and referral of patients who report suicidal thought during a primary care visit. Gardner, W., Klima, J., Chisolm, D., et al.[2022]

The telehealth suicide safety planning intervention (SPI) was found to be highly acceptable and feasible among high-risk Veterans, with participants rating it positively on acceptability (M=17.50), appropriateness (M=17.25), and feasibility (M=18) on a scale of 1 to 20.

Participants reported enhanced suicidal disclosure and improved management of urges, indicating that the SPI effectively supported their mental health needs while also addressing barriers like privacy and technology issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Qualitative Study of Telehealth Delivery of Suicide-Specific Group Treatment "Project Life Force". Patel, SR., Sullivan, SR., Mitchell, EL., et al.[2023]

The study analyzed responses from 49 patients regarding helpful aspects of their treatment for suicidal risk, leading to the development of a reliable coding system to identify major themes in their experiences.

Insights gained from 52 patients on what they learned from their clinical care can inform future suicide-specific treatments, highlighting the importance of patient feedback in improving therapeutic approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful Treatment of Suicidal Risk. Schembari, BC., Jobes, DA., Horgan, RJ.[2022]

A significant 25% of patients who attempted suicide and were admitted to a mental institution received no aftercare, highlighting a gap in post-admission support.

Among those who did receive aftercare, most started within two weeks, but only 50% continued to receive care nine months later, indicating a need for improved continuity in mental health support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Continuity of care following suicide-related compulsory admission]. De Vries, SC., Wierdsma, AI., Mulder, CL.[2008]

Citations

1. medicine.umich.edu medicine.umich.edu/dept/psychiatry/programs/youth-young-adult-depression-suicide-prevention-program/current-research-initiatives

Current Research Initiatives | Psychiatry - Michigan Medicine WeCARE: A System of Care for Black Youth at Risk for Suicide. A System of ... suicide-related outcomes following the transition from inpatient care.

2. medicine.umich.edu medicine.umich.edu/dept/psychiatry/news/archive/202309/every-life-worth-living-preventing-suicide-through-education-intervention

Every Life is Worth Living: Preventing Suicide Through ... Recognizing the warning signs and risk factors of suicide is crucial for early identification of risk and timely intervention. Being attentive ...

3. go.drugbank.com go.drugbank.com/conditions/DBCOND0167514

Suicidal Ideations (DBCOND0167514) Exploring the Effectiveness of a Suicide Ideation Prevention ... Suicide Outcomes in Primary Care Settings, No drug interventions, prevention, Not Available ...

4. ajmc.com ajmc.com/view/collaborative-care-model-offers-success-in-reducing-suicide-risk-new-report-finds

Collaborative Care Model Offers Success in Reducing ... Suicidal ideation declined from 11% to 7% over the course of care, with severity rarely worsening. Both depression and anxiety scores improved ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12005173/

Effectiveness of Integrating Suicide Care in Primary Care Implementation of population-based SC concurrent with a substance use program resulted in a 25% reduction in the suicide attempt rate in the 90 days after ...

6. aha.org aha.org/suicideprevention/health-care-workforce/suicide-prevention-guide

Suicide Prevention: Evidence-Informed Interventions for ... This guide shares twelve evidence-informed interventions for preventing suicide and improving mental well-being for the health care workforce.

7. preventsuicideny.org preventsuicideny.org/wp-content/uploads/2022/11/AIM-for-Zero-Suicides-Implementation-Guide.pdf

AIM for Zero Suicides Implementation Guide Implementation of the Zero Suicide model starts with a commitment from health system leadership to reduce suicide deaths among all those receiving care. The ...