WeCare: A System of Care for Black Youth

NCT05654207 | Recruiting DMC

• 1 other identifier: R01MH129786-01
• Study Type: interventional
• Target: 2,200
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Suicidal Ideation

Keywords

suicide; ideation; Black youth; depression

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  Baseline, Months 3 and 6

Secondary Outcomes (12)

• Attitudes Toward Psychological Help Scale

  Baseline, Months 3 and 6

• Barriers

  Baseline, Months 3 and 6

• Caregiver Knowledge of Mental Health Services (Therapy Survey)

  Baseline, Months 3 and 6

• ED STARS Mental Health Service Use

  Baseline, Months 3 and 6

• Hopelessness

  Baseline, Months 3 and 6

Other Outcomes (24)

• Self-Efficacy

  Baseline, Months 3 and 6

• YRBS-Alcohol

  Baseline, Months 3 and 6

• Drug Use Scale

  Baseline, Months 3 and 6

Study Arms (2)

WeCare

EXPERIMENTAL

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

Behavioral: WeCare

Usual Services

NO INTERVENTION

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

Interventions

WeCare 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.

WeCare

Eligibility Criteria

• Age: 12 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• New York University: lead
• University of Michigan: collaborator

Study Sites (1)

Kings County Hospital

New York, New York, 11203, United States

RECRUITING

MeSH Terms

Conditions

Suicidal Ideation; Suicide; Depression

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Michael A Lindsey, PhD

  New York University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael A Lindsey, PhD

CONTACT

(212) 998-5959; michael.lindsey@nyu.edu

Jacqueline Holloway, PhD

CONTACT

973-941-2376; jacqueline.holloway@nyu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: December 16, 2022
• Study Start: April 8, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: October 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: By the end of data collection, March 2027.
• Access Criteria: In accordance with the NIMH Data Archive requirements.

Locations

US (1)