Suicidal IdeationWeCareNCT05654207
WeCare: A System of Care for Black Youth
A study testing WeCare in people with Suicidal Ideation, run by New York University at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 12 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Suicidal Ideation
- What is being tested?
- WeCare
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,200 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2024to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Adolescents aged 12-17 years and their parents or guardians, and adolescents 18-19 years who have the option for their parent or guardian to participate
- Having a parent/caregiver present in the ED to consent or available to consent remotely (12-17 year olds, only)
- Having a cellular phone with text messaging capacity
- Adolescent able to speak English, and understand study questions
- Parents able to consent in English, Spanish, French or Creole
- Meet screening criteria
Who cannot join
- Adolescent is medically unstable
- Adolescent present with severe cognitive impairment
- Parents are not present in the ED, unable to consent remotely, and not able to give consent in either English, Spanish, French or Creole (12-17 year olds, only)
- Adolescent does not have access to cellular phone
- Adolescents active in mental health treatment (e.g., seen a therapist, social worker, or mental health provider in the last week)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Kings County Hospital
New York, New York, 11203
Nasreen Akbar, MD, 718-245-2502, akbarn@nychhc.org
Nicholas Bove, boven@nychhc.org
About this study
Official title: Answering the Alarm: A System of Care for Black Youth at Risk for Suicide
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.
Read the detailed description
From 1991 through 2017, suicide attempts increased by 73% among Black high school-aged youth, and suicide attempts requiring hospitalization increased by 122% for Black high school-aged boys. These alarming findings, in part, led to the creation of the Emergency Taskforce on Black Youth Suicide and Mental Health and their subsequent report, Ring the Alarm: The Crisis of Black Youth Suicide in America, and passage of the Pursuing Equity in Mental Act. These all highlight the urgent need to improve suicide risk detection, treatment, and prevention among Black youth.
We propose to respond to these challenges and the urgent need for an effective suicide prevention strategy for Black youth by examining the effectiveness of an "easily implementable," "systems-level" strategy to recognize and respond to suicide risk among Black youth who present to EDs. WeCare combines (1) CASSY, a universal screening; (2) CFS, an intervention with elements from SAFETY-Acute (SAFETY-A), an evidence-based, family-centered intervention to safety planning for children and adolescents; (3) Safety Planning Intervention (SPI), a brief ED-based intervention of a written list prioritizing coping strategies and sources of support to alleviate a suicidal crisis; (3) Making Connections Intervention (MCI), a mental health engagement intervention for Black adolescents and their parents; and (4) a follow-up text messaging support system for youth and parents will be introduced for enhanced feasibility.
This study is a randomized clinical effectiveness trial with 2,200 Black youth at risk for suicide to examine the effectiveness of WeCare. Youth, ages 12 to 19 years, enrolled from two hospital EDs in New York City, will be assessed on enrollment for risks associated with suicide. Moderate/high-risk youth will be randomly assigned to WeCare vs. usual services. Survey assessments will be conducted at 3- and 6-month follow-up, with medical record review through 12 months to examine the effectiveness of WeCare and mediators of WeCare effects. The objective is to increase risk identification, treatment referral and engagement, and, in turn, reduce suicidal ideation and behavior among Black youth.
- Conditions
- Suicidal Ideation
- Being tested
- WeCare
- Keywords
- suicide, ideation, Black youth, depression
- Medical subject headings
- Suicidal Ideation, Suicide, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WeCareBehavioural
WeCare combines two evidence-based strategies -- universal screening using the Computerized Adaptive Screen for Suicidal Youth and an adapted version of the SAFETY-ACUTE, which incorporates PI Lindsey's extensive work with Black youth, their families, and community stakeholders to develop culturally tailored strategies for addressing treatment barriers.
| Study group | Role | What they receive |
|---|---|---|
| WeCare | Experimental | WeCare system of care - universal screening, ED-based intervention, text message follow-up. Receives: Behavioral: WeCare |
| Usual Services | No intervention | Usual care for youth presenting to the ED will be the control condition. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental Health Outpatient Visits (Electronic Medical Record)
This measure assesses mental health service utilization from 50 patient care locations in New York City via electronic medical records.
Measured: Baseline, Months 3 and 6
Columbia-Suicide Severity Rating Scale
This measure is a semi structured interview to assess suicidal ideation and attempt This measure is a semi structured interview to assess suicidal ideation and attempt behavior (actual, interrupted, aborted suicide attempts; preparatory behavior).
Measured: Baseline, Months 3 and 6
Secondary outcomes (12)
Attitudes Toward Psychological Help Scale
This measure assesses psychological factors, including stigma, perceived relevance of treatment, etc. that impact one's perceptions and attitudes about using formal mental health treatment services.
Measured: Baseline, Months 3 and 6
Barriers
This 5-item measure captures barriers to MH treatment participation identified in PI Lindsey's prior work with Black youth and families. A higher score indicates a perception of more barriers to treatment (Minimum score: 5; Maximum score: 15).
Measured: Baseline, Months 3 and 6
Caregiver Knowledge of Mental Health Services (Therapy Survey)
This measures expectations about treatment at a children's psychiatric clinic (caregiver).
Measured: Baseline, Months 3 and 6
ED STARS Mental Health Service Use
This measure assesses mental health service utilization, efforts to link to services, linkage, and engagement with outpatient MH services (caregiver).
Measured: Baseline, Months 3 and 6
Hopelessness
This measure targets recent feelings of hopelessness and hope.
Measured: Baseline, Months 3 and 6
Parent-Family Connectedness Scale
This measure assesses familial connectedness.
Measured: Baseline, Months 3 and 6
How I Feel about Friends
This 2-ite, measure assesses peer connectedness. Higher scores indicate greater peer connectedness (Minimum score: 2; Maximum score: 10).
Measured: Baseline, Months 3 and 6
Peer Victimization and Perpetration
This measure assesses bullying.
Measured: Baseline, Months 3 and 6
Urgency Premeditated Perseverance Sensation Seeking Subscale
This measure assesses impulsivity.
Measured: Baseline, Months 3 and 6
Mental Health Service Use
This measure assesses lifetime mental health service use (caregiver).
Measured: Baseline, Months 3 and 6
Stages of Change
This 8-item measure assesses adolescents' willingness to change (Minimum score: 8; Maximum score: 32).
Measured: Baseline, Months 3 and 6
Barriers to Treatment Participation Scale
This measure assesses barriers to treatment (caregiver).
Measured: Baseline, Months 3 and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start8 Apr 2024
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicidal IdeationStudies of the same condition, open and under way.
- More trials run by New York UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan
- Responsible party
- Sponsor
- Investigators
- Michael A Lindsey, PhD, Principal investigator, New York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05654207
- Sponsor's protocol ID
- R01MH129786-01
- Acronym
- WeCare
- Status last verified
- Apr 2026
- First submitted
- 30 Nov 2022
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Submit data in compliance with NIMH Data Archive data submission agreement.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Answering the Alarm: A System of Care for Black Youth at Risk for Suicide
- ClinicalTrials.gov ID
- NCT05654207
- Acronym / sponsor ID
- WeCare / R01MH129786-01
- Conditions
- Suicidal Ideation
- Keywords
- suicide, ideation, Black youth, depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,200 participants (estimated)
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Collaborators
- University of Michigan
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 16 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
From 1991 through 2017, suicide attempts increased by 73% among Black high school-aged youth, and suicide attempts requiring hospitalization increased by 122% for Black high school-aged boys. These alarming findings, in part, led to the creation of the Emergency Taskforce on Black Youth Suicide and Mental Health and their subsequent report, Ring the Alarm: The Crisis of Black Youth Suicide in America, and passage of the Pursuing Equity in Mental Act. These all highlight the urgent need to improve suicide risk detection, treatment, and prevention among Black youth.
We propose to respond to these challenges and the urgent need for an effective suicide prevention strategy for Black youth by examining the effectiveness of an "easily implementable," "systems-level" strategy to recognize and respond to suicide risk among Black youth who present to EDs. WeCare combines (1) CASSY, a universal screening; (2) CFS, an intervention with elements from SAFETY-Acute (SAFETY-A), an evidence-based, family-centered intervention to safety planning for children and adolescents; (3) Safety Planning Intervention (SPI), a brief ED-based intervention of a written list prioritizing coping strategies and sources of support to alleviate a suicidal crisis; (3) Making Connections Intervention (MCI), a mental health engagement intervention for Black adolescents and their parents; and (4) a follow-up text messaging support system for youth and parents will be introduced for enhanced feasibility.
This study is a randomized clinical effectiveness trial with 2,200 Black youth at risk for suicide to examine the effectiveness of WeCare. Youth, ages 12 to 19 years, enrolled from two hospital EDs in New York City, will be assessed on enrollment for risks associated with suicide. Moderate/high-risk youth will be randomly assigned to WeCare vs. usual services. Survey assessments will be conducted at 3- and 6-month follow-up, with medical record review through 12 months to examine the effectiveness of WeCare and mediators of WeCare effects. The objective is to increase risk identification, treatment referral and engagement, and, in turn, reduce suicidal ideation and behavior among Black youth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WeCare | Experimental | Behavioral: WeCareWeCare system of care - universal screening, ED-based intervention, text message follow-up. |
| Usual Services | No intervention | –Usual care for youth presenting to the ED will be the control condition. |
Who may qualify
- Ages
- 12 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Adolescents aged 12-17 years and their parents or guardians, and adolescents 18-19 years who have the option for their parent or guardian to participate
- Having a parent/caregiver present in the ED to consent or available to consent remotely (12-17 year olds, only)
- Having a cellular phone with text messaging capacity
- Adolescent able to speak English, and understand study questions
- Parents able to consent in English, Spanish, French or Creole
Key exclusion criteria (5 listed)
- Adolescent is medically unstable
- Adolescent present with severe cognitive impairment
- Parents are not present in the ED, unable to consent remotely, and not able to give consent in either English, Spanish, French or Creole (12-17 year olds, only)
- Adolescent does not have access to cellular phone
- Adolescents active in mental health treatment (e.g., seen a therapist, social worker, or mental health provider in the last week)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WeCareWeCare combines two evidence-based strategies -- universal screening using the Computerized Adaptive Screen for Suicidal Youth and an adapted version of the SAFETY-ACUTE, which incorporates PI Lindsey's extensive work with Black youth, their families, and community stakeholders to develop culturally tailored strategies for addressing treatment barriers. | Behavioural | WeCare |
Primary outcome
Mental Health Outpatient Visits (Electronic Medical Record)
Time frame: Baseline, Months 3 and 6
This measure assesses mental health service utilization from 50 patient care locations in New York City via electronic medical records.
Columbia-Suicide Severity Rating Scale
Time frame: Baseline, Months 3 and 6
This measure is a semi structured interview to assess suicidal ideation and attempt This measure is a semi structured interview to assess suicidal ideation and attempt behavior (actual, interrupted, aborted suicide attempts; preparatory behavior).
12 secondary outcomes
Attitudes Toward Psychological Help Scale
Time frame: Baseline, Months 3 and 6
Barriers
Time frame: Baseline, Months 3 and 6
Caregiver Knowledge of Mental Health Services (Therapy Survey)
Time frame: Baseline, Months 3 and 6
ED STARS Mental Health Service Use
Time frame: Baseline, Months 3 and 6
Hopelessness
Time frame: Baseline, Months 3 and 6
Parent-Family Connectedness Scale
Time frame: Baseline, Months 3 and 6
How I Feel about Friends
Time frame: Baseline, Months 3 and 6
Peer Victimization and Perpetration
Time frame: Baseline, Months 3 and 6
Urgency Premeditated Perseverance Sensation Seeking Subscale
Time frame: Baseline, Months 3 and 6
Mental Health Service Use
Time frame: Baseline, Months 3 and 6
Stages of Change
Time frame: Baseline, Months 3 and 6
Barriers to Treatment Participation Scale
Time frame: Baseline, Months 3 and 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: Yes. Submit data in compliance with NIMH Data Archive data submission agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael A Lindsey, PhD principal investigator
New York University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WeCare in people with Suicidal Ideation, run by New York University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael A Lindsey, PhD ((212) 998-5959, michael.lindsey@nyu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mental Health Outpatient Visits (Electronic Medical Record) (time frame: Baseline, Months 3 and 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.