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Answering the Alarm: A System of Care for Black Youth at Risk for Suicide (WeCare) (WeCare)

Primary Purpose

Suicidal Ideation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
WeCare
Sponsored by
New York University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Suicidal Ideation focused on measuring suicide, ideation, black youth, depression, system of care, emergency department

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Inclusion criteria adolescent and parent/guardians: Adolescents aged 12-17 years and their parents or guardians Having a parent/caregiver present in the emergency department to consent Having a cellular phone Adolescent able to speak English, and understand study questions Parents able to consent in English, Spanish, or Creole Meet screening criteria Inclusion criteria for ED clinical providers and administrative stakeholders: Currently employed at Kings or Harlem Hospital and working in the hospital ED on at least a half-time basis Age 18 or above Exclusion Criteria: Exclusion criteria adolescent and parent/guardians: 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, or Creole Adolescent does not have access to cellular phone Exclusion criteria for ED clinical providers and administrative stakeholders: 1. Not currently employed at least part-time in the hospital ED

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    WeCare

    Usual Services

    Arm Description

    WeCare is a system of care that combines two evidence-based strategies -- universal screening using the Computerized Adaptive Screen for Suicidal Youth (CASSY) and an adapted version of the SAFETY ACUTE that incorporates PI Lindsey's extensive work with Black youth, their families, and community stakeholders to develop culturally tailored strategies for addressing treatment barriers, with a technological adaptation for increased feasibility (i.e., follow-up text messaging).

    Usual emergency departments services will be offered to participants.

    Outcomes

    Primary Outcome Measures

    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.
    Columbia-Suicide Severity Rating Scale
    This measure is a 5-item semi-structured interview to assess suicidal behavior (actual, interrupted, aborted suicide attempts; preparatory behavior).

    Secondary Outcome Measures

    Full Information

    First Posted
    November 30, 2022
    Last Updated
    May 12, 2023
    Sponsor
    New York University
    Collaborators
    University of Michigan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05654207
    Brief Title
    Answering the Alarm: A System of Care for Black Youth at Risk for Suicide (WeCare)
    Acronym
    WeCare
    Official Title
    Answering the Alarm: A System of Care for Black Youth at Risk for Suicide
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 15, 2023 (Anticipated)
    Primary Completion Date
    March 31, 2027 (Anticipated)
    Study Completion Date
    March 31, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    New York University
    Collaborators
    University of Michigan

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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). This strategy, 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 (MCI, Lindsey et al., 2009). Study objectives are to integrate input from multiple stakeholders to inform and facilitate WeCare implementation, and 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 Health Act. These all highlight the urgent need to improve suicide risk detection, treatment, and prevention among Black youth. The challenges of suicide prevention among Black youth are manifold. Many suicidal Black youth are unidentified, fewer than half are referred to treatment following an emergency department visit, and many referred youth do not adhere to treatment. Yet, prior research has not examined the effectiveness of a system of care for Black youth that combines suicide risk screening with an intervention to enhance linkage to quality mental health services. 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 emergency departments (EDs). Our strategy, WeCare, combines two evidence-based strategies -- universal screening using the Computerized Adaptive Screen for Suicidal Youth (CASSY) and an adapted version of the SAFETYACUTE that incorporates PI Lindsey's extensive work with Black youth, their families, and community stakeholders to develop culturally tailored strategies for addressing treatment barriers, with a technological adaptation for increased feasibility (i.e., follow-up text messaging). Implementation theory and research emphasizes the importance of obtaining input from multiple levels of stakeholders, including consumers (youth and their parents), providers (ED clinicians), medical directors and program administrators, and policy makers across the phases of intervention adaptation and implementation prior to an effectiveness trial of WeCare. Although we are not revising the core components of SAFETY-A, this framework will enable us to culturally tailor SAFETY-A for Black youth and technologically update it to use text messages (instead of telephone calls). The ED is an optimal setting to test this strategy because ED visits for youth suicide risk have more than doubled in recent years, EDs are a common point of access for mental health services, and parents and youth view suicide risk screening in the ED favorably. Our goal is to increase risk identification, treatment referral and engagement, and, in turn, reduce suicidal ideation and behavior among Black youth.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Suicidal Ideation
    Keywords
    suicide, ideation, black youth, depression, system of care, emergency department

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    2200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    WeCare
    Arm Type
    Experimental
    Arm Description
    WeCare is a system of care that combines two evidence-based strategies -- universal screening using the Computerized Adaptive Screen for Suicidal Youth (CASSY) and an adapted version of the SAFETY ACUTE that incorporates PI Lindsey's extensive work with Black youth, their families, and community stakeholders to develop culturally tailored strategies for addressing treatment barriers, with a technological adaptation for increased feasibility (i.e., follow-up text messaging).
    Arm Title
    Usual Services
    Arm Type
    No Intervention
    Arm Description
    Usual emergency departments services will be offered to participants.
    Intervention Type
    Behavioral
    Intervention Name(s)
    WeCare
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Mental Health Outpatient Visits (Electronic Medical Record)
    Description
    This measure assesses mental health service utilization from 50 patient care locations in New York City via electronic medical records.
    Time Frame
    3-month follow-up
    Title
    Columbia-Suicide Severity Rating Scale
    Description
    This measure is a 5-item semi-structured interview to assess suicidal behavior (actual, interrupted, aborted suicide attempts; preparatory behavior).
    Time Frame
    3-month follow-up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Inclusion criteria adolescent and parent/guardians: Adolescents aged 12-17 years and their parents or guardians Having a parent/caregiver present in the emergency department to consent Having a cellular phone Adolescent able to speak English, and understand study questions Parents able to consent in English, Spanish, or Creole Meet screening criteria Inclusion criteria for ED clinical providers and administrative stakeholders: Currently employed at Kings or Harlem Hospital and working in the hospital ED on at least a half-time basis Age 18 or above Exclusion Criteria: Exclusion criteria adolescent and parent/guardians: 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, or Creole Adolescent does not have access to cellular phone Exclusion criteria for ED clinical providers and administrative stakeholders: 1. Not currently employed at least part-time in the hospital ED
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Michael A Lindsey, PhD
    Phone
    (212) 998-5959
    Email
    ml4361@nyu.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Damali Wilson, PhD
    Phone
    (212) 992-9726
    Email
    damali.wilson@nyu.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Answering the Alarm: A System of Care for Black Youth at Risk for Suicide (WeCare)

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