WeCare: A System of Care for Black Youth

NCT ID: NCT05654207

Last Updated: 2025-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

2200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-08

Study Completion Date

2027-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Suicidal Ideation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

WeCare

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

Group Type EXPERIMENTAL

WeCare

Intervention Type BEHAVIORAL

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.

Usual Services

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

WeCare

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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 (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

Exclusion Criteria

* Adolescent is medically unstable
* Adolescent present with severe cognitive impairment
* Parents are not present in the ED and available 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)
Minimum Eligible Age

12 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Michigan

OTHER

Sponsor Role collaborator

New York University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Michael A Lindsey, PhD

Role: PRINCIPAL_INVESTIGATOR

New York University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kings County Hospital

New York, New York, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Michael A Lindsey, PhD

Role: CONTACT

(212) 998-5959

Jacqueline Holloway, PhD

Role: CONTACT

973-941-2376

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Nasreen Akbar, MD

Role: primary

718-245-2502

Nicholas Bove

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01MH129786-01

Identifier Type: NIH

Identifier Source: org_study_id

View Link

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Peer Based Suicide Prevention
NCT04222673 COMPLETED NA
Preventing Suicide in African American Adolescents
NCT04253002 ACTIVE_NOT_RECRUITING NA
Step 1: Be Aware, Anxiety Prevention Intervention
NCT07044752 ENROLLING_BY_INVITATION NA