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

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. However, if you are actively receiving mental health treatment, you may not be eligible to participate.

What data supports the effectiveness of the WeCare treatment for suicidal thoughts?

The Collaborative Assessment and Management of Suicidality (CAMS), a similar approach to WeCare, has been shown to be more effective than usual care in reducing suicidal thoughts and attempts in soldiers. Additionally, using technology to monitor and engage at-risk individuals, as mentioned in the Zero Suicide model, shows promise in improving care for suicidal patients. ^{1 2 3 4 5}

How is the WeCare treatment for suicidal thoughts different from other treatments?

The WeCare treatment is unique because it involves a comprehensive system of care that includes a coordinated suicide-prevention team and possibly peer support, which is different from traditional treatments that may not offer such integrated and supportive approaches. ^{6 7 8 9 10}

What is the purpose of this trial?

The overall goal of this study is to respond to the urgent need for an effective suicide prevention strategy for Black youth by examining the effectiveness of a systems-level strategy to recognize and respond to suicide risk among Black adolescents who present to emergency departments (EDs). The proposed strategy, WeCare, combines combines three components: (1) universal screening using the Computerized Adaptive Screen for Suicidal Youth (CASSY), (2) a brief intervention designed for Black youth with elevated suicide risk in for ED settings, Connections for Safety (CFS), that combines safety planning and strategies to support linkage to outpatient mental health services, and (3) supportive text messages to youth and parent/caregivers for six weeks following the youth's ED visit. Study objectives are (1) to integrate input from multiple stakeholders to inform and facilitate WeCare implementation, and (2) to use a hybrid one effectiveness-implementation design to evaluate its effectiveness.

Research Team

Michael A Lindsey, PhD

Principal Investigator

New York University

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Suicide prevention in a treatment setting. [2022]

2. United States 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. [2019]

3. Canada pubmed.ncbi.nlm.nih.gov

Successful Treatment of Suicidal Risk. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

[Continuity of care following suicide-related compulsory admission]. [2008]

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

The Need for Innovation in Health Care Systems to Improve Suicide Prevention. [2022]

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

Screening, triage, and referral of patients who report suicidal thought during a primary care visit. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Piloting a Peer Support Program for Patients Who Screen Positive for Intimate Partner Violence, Suicidal Ideation, and Depression. [2023]

8. United States 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. [2022]

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

A stepped care approach to clinical suicide prevention. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Qualitative Study of Telehealth Delivery of Suicide-Specific Group Treatment "Project Life Force". [2023]