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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.

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Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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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
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

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.

Michael A Lindsey, PhD contact

(212) 998-5959

michael.lindsey@nyu.edu

Jacqueline Holloway, PhD contact

973-941-2376

jacqueline.holloway@nyu.edu

United States1 site, 1 recruiting
  • Kings County Hospital

    New York, New York, 11203

    Nasreen Akbar, MD, 718-245-2502, akbarn@nychhc.org

    Nicholas Bove, boven@nychhc.org

    Recruiting

Other trials in United States

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.

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 groups in NCT05654207
Study groupRoleWhat they receive
WeCareExperimentalWeCare system of care - universal screening, ED-based intervention, text message follow-up.
Receives: Behavioral: WeCare
Usual ServicesNo interventionUsual 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.

  1. 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

  2. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. Hopelessness

    This measure targets recent feelings of hopelessness and hope.

    Measured: Baseline, Months 3 and 6

  6. Parent-Family Connectedness Scale

    This measure assesses familial connectedness.

    Measured: Baseline, Months 3 and 6

  7. 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

  8. Peer Victimization and Perpetration

    This measure assesses bullying.

    Measured: Baseline, Months 3 and 6

  9. Urgency Premeditated Perseverance Sensation Seeking Subscale

    This measure assesses impulsivity.

    Measured: Baseline, Months 3 and 6

  10. Mental Health Service Use

    This measure assesses lifetime mental health service use (caregiver).

    Measured: Baseline, Months 3 and 6

  11. Stages of Change

    This 8-item measure assesses adolescents' willingness to change (Minimum score: 8; Maximum score: 32).

    Measured: Baseline, Months 3 and 6

  12. 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.

  1. First posted16 Dec 2022
  2. Study start8 Apr 2024
  3. Primary completion1 Apr 2027 (estimated)
  4. Study completion1 Apr 2027 (estimated)

Resources

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)
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.

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