- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05654207
WeCare: A System of Care for Black Youth (WeCare)
Answering the Alarm: A System of Care for Black Youth at Risk for Suicide
Study Overview
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Damali Wilson, PhD
- Phone Number: (212) 992-9726
- Email: damali.wilson@nyu.edu
Study Contact Backup
- Name: Michael A Lindsey, PhD
- Phone Number: (212) 998-5959
- Email: michael.lindsey@nyu.edu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion criteria adolescent and parent/guardians:
- 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 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, 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: WeCare
WeCare system of care - universal screening, ED-based intervention, text message follow-up.
|
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.
|
No Intervention: Usual Services
Usual care for youth presenting to the ED will be the control condition.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, Months 3 and 6
|
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).
|
Baseline, Months 3 and 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Attitudes Toward Psychological Help Scale
Time Frame: Baseline, Months 3 and 6
|
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.
|
Baseline, Months 3 and 6
|
Barriers
Time Frame: Baseline, Months 3 and 6
|
This measure captures barriers to MH treatment participation identified in PI Lindsey's prior work with Black youth and families.
|
Baseline, Months 3 and 6
|
Caregiver Knowledge of Mental Health Services (Therapy Survey)
Time Frame: Baseline, Months 3 and 6
|
This measures expectations about treatment at a children's psychiatric clinic (caregiver).
|
Baseline, Months 3 and 6
|
ED STARS Mental Health Service Use
Time Frame: Baseline, Months 3 and 6
|
This measure assesses mental health service utilization, efforts to link to services, linkage, and engagement with outpatient MH services (caregiver).
|
Baseline, Months 3 and 6
|
Hopelessness
Time Frame: Baseline, Months 3 and 6
|
This measure targets recent feelings of hopelessness and hope.
|
Baseline, Months 3 and 6
|
Parent-Family Connectedness Scale
Time Frame: Baseline, Months 3 and 6
|
This measure assesses familial connectedness.
|
Baseline, Months 3 and 6
|
How I Feel about Friends
Time Frame: Baseline, Months 3 and 6
|
This measure assesses peer connectedness.
|
Baseline, Months 3 and 6
|
Peer Victimization and Perpetration
Time Frame: Baseline, Months 3 and 6
|
This measure assesses bullying.
|
Baseline, Months 3 and 6
|
Urgency Premeditated Perseverance Sensation Seeking Subscale
Time Frame: Baseline, Months 3 and 6
|
This measure assesses impulsivity.
|
Baseline, Months 3 and 6
|
Mental Health Service Use
Time Frame: Baseline, Months 3 and 6
|
This measure assesses lifetime mental health service use (caregiver).
|
Baseline, Months 3 and 6
|
Stages of Change
Time Frame: Baseline, Months 3 and 6
|
This measure assesses adolescents' willingness to change.
|
Baseline, Months 3 and 6
|
Barriers to Treatment Participation Scale
Time Frame: Baseline, Months 3 and 6
|
This measure assesses barriers to treatment (caregiver).
|
Baseline, Months 3 and 6
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-Efficacy
Time Frame: Baseline, Months 3 and 6
|
This measure assesses adolescents' confidence in use of different coping behaviors (commonly incorporated in safety plans) when experiencing suicidal thoughts.
|
Baseline, Months 3 and 6
|
YRBS-Alcohol
Time Frame: Baseline, Months 3 and 6
|
This measure assesses alcohol use.
|
Baseline, Months 3 and 6
|
Drug Use Scale
Time Frame: Baseline, Months 3 and 6
|
This measure assesses adolescents' behaviors related to drug use.
|
Baseline, Months 3 and 6
|
YRBS-Physical Fights
Time Frame: Baseline, Months 3 and 6
|
This item measures frequency of physical fighting.
|
Baseline, Months 3 and 6
|
Lethal Means Restriction
Time Frame: Baseline, Months 3 and 6
|
This measure assesses adolescents' access to lethal means (caregiver).
|
Baseline, Months 3 and 6
|
Perceived Effectiveness of Treatment
Time Frame: Baseline, Month 3
|
This measure assesses perceived treatment effectiveness.
|
Baseline, Month 3
|
Purpose in Life
Time Frame: Baseline, Months 3 and 6
|
This measure assesses adolescents' sense of purpose
|
Baseline, Months 3 and 6
|
Thoughts about Mortality
Time Frame: Baseline, Month 6
|
This measure assesses beliefs and attitudes towards death.
|
Baseline, Month 6
|
Suicidal Thoughts
Time Frame: Baseline, Months 3 and 6
|
This instruments measures the frequency of suicidal thoughts (only if participant responds YES to CSSRS 1 or 2).
|
Baseline, Months 3 and 6
|
Exposure to Suicide
Time Frame: Baseline, Months 3 and 6
|
This measure assesses if adolescents had exposure to someone who attempted or died by suicide.
|
Baseline, Months 3 and 6
|
Acquired Capability for Suicide
Time Frame: Baseline, Months 3 and 6
|
This measure assesses fearlessness of death.
|
Baseline, Months 3 and 6
|
Demographics
Time Frame: Baseline, Months 3 and 6
|
This survey queries background characteristics (youth and caregiver versions).
|
Baseline, Months 3 and 6
|
Gender Identity and Sexual Orientation
Time Frame: Baseline, Months 3 and 6
|
This survey queries adolescents' gender identity and sexual orientation.
|
Baseline, Months 3 and 6
|
Purpose in Life (Expanded)
Time Frame: Baseline, Months 3 and 6
|
Expanded version of baseline purpose of life measure.
|
Baseline, Months 3 and 6
|
Regard of Identity
Time Frame: Baseline, Months 3 and 6
|
The measure assesses regard for racial identity.
|
Baseline, Months 3 and 6
|
Social Competencies
Time Frame: Baseline, Months 3 and 6
|
This measure assesses social skills.
|
Baseline, Months 3 and 6
|
Religious Identity
Time Frame: Baseline, Months 3 and 6
|
This survey queries religious identity (caregiver).
|
Baseline, Months 3 and 6
|
Acculturation
Time Frame: Baseline, Months 3 and 6
|
This survey asks about acculturation to the United States (caregiver).
|
Baseline, Months 3 and 6
|
Medical Mistrust
Time Frame: Baseline, Months 3 and 6
|
This measure assesses medical mistrust (caregiver).
|
Baseline, Months 3 and 6
|
PedsQL
Time Frame: Baseline, Months 3 and 6
|
This measure assesses caregiver-reported issues youth face.
|
Baseline, Months 3 and 6
|
ED-s Risk Survey (from ED-STARS)
Time Frame: Baseline, Months 3 and 6
|
This survey measure assesses the duration of suicidal thoughts, family and social connectedness, peer victimization and bullying, impulsive-aggression, physical fighting, and overall adaptive functioning.
|
Baseline, Months 3 and 6
|
Work and Social Adjustment Scale - Youth (Parent version)
Time Frame: Months 3 and 6
|
This measure assesses the impact of youth's problem to do certain day-to-day tasks (caregiver).
|
Months 3 and 6
|
iBelong
Time Frame: Baseline, Month 6
|
This measure assesses adolescents' sense of belongingness.
|
Baseline, Month 6
|
Joy
Time Frame: Months 3 and 6
|
This measure assesses adolescents' sense of joy in their life.
|
Months 3 and 6
|
Data Archive Collection Items
Time Frame: Baseline, Months 3 and 6
|
These items are shared data with the wider scientific community to assess mental and physical health concerns and wellbeing.
|
Baseline, Months 3 and 6
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Michael A Lindsey, PhD, New York University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01MH129786-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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