Clinical trial NCT05654207: WeCare: A System of Care for Black Youth
Official title: Answering the Alarm: A System of Care for Black Youth at Risk for Suicide
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Suicidal Ideation
Keywords: suicide
ideation
Black youth
depression
Lead sponsor: New York University
Sponsor class: OTHER
Collaborators: name: University of Michigan
First posted: 2022-12-16
Enrollment: 2200
Sex: ALL
Minimum age (years): 12
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Mental Health Outpatient Visits (Electronic Medical Record)
timeFrame: Baseline, Months 3 and 6
measure: Columbia-Suicide Severity Rating Scale
timeFrame: Baseline, Months 3 and 6
Secondary outcomes:
measure: Attitudes Toward Psychological Help Scale
timeFrame: Baseline, Months 3 and 6
measure: Barriers
timeFrame: Baseline, Months 3 and 6
measure: Caregiver Knowledge of Mental Health Services (Therapy Survey)
timeFrame: Baseline, Months 3 and 6
measure: ED STARS Mental Health Service Use
timeFrame: Baseline, Months 3 and 6
measure: Hopelessness
timeFrame: Baseline, Months 3 and 6
measure: Parent-Family Connectedness Scale
timeFrame: Baseline, Months 3 and 6
measure: How I Feel about Friends
timeFrame: Baseline, Months 3 and 6
measure: Peer Victimization and Perpetration
timeFrame: Baseline, Months 3 and 6
measure: Urgency Premeditated Perseverance Sensation Seeking Subscale
timeFrame: Baseline, Months 3 and 6
measure: Mental Health Service Use
timeFrame: Baseline, Months 3 and 6
measure: Stages of Change
timeFrame: Baseline, Months 3 and 6
measure: Barriers to Treatment Participation Scale
timeFrame: Baseline, Months 3 and 6
Other outcomes:
measure: Self-Efficacy
timeFrame: Baseline, Months 3 and 6
measure: YRBS-Alcohol
timeFrame: Baseline, Months 3 and 6
measure: Drug Use Scale
timeFrame: Baseline, Months 3 and 6
measure: YRBS-Physical Fights
timeFrame: Baseline, Months 3 and 6
measure: Lethal Means Restriction
timeFrame: Baseline, Months 3 and 6
measure: Perceived Effectiveness of Treatment
timeFrame: Baseline, Month 3
measure: Purpose in Life
timeFrame: Baseline, Months 3 and 6
measure: Thoughts about Mortality
timeFrame: Baseline, Month 6
measure: Suicidal Thoughts
timeFrame: Baseline, Months 3 and 6
measure: Exposure to Suicide
timeFrame: Baseline, Months 3 and 6
measure: Acquired Capability for Suicide
timeFrame: Baseline, Months 3 and 6
measure: Demographics
timeFrame: Baseline, Months 3 and 6
measure: Gender Identity and Sexual Orientation
timeFrame: Baseline, Months 3 and 6
measure: Purpose in Life (Expanded)
timeFrame: Months 3 and 6
measure: Regard of Identity
timeFrame: Baseline, Months 3 and 6
measure: Social Competencies
timeFrame: Baseline, Months 3 and 6
measure: Religious Identity
timeFrame: Baseline, Months 3 and 6
measure: Medical Mistrust
timeFrame: Baseline, Months 3 and 6
measure: PedsQL
timeFrame: Baseline, Months 3 and 6
measure: ED-s Risk Survey (from ED-STARS)
timeFrame: Baseline, Months 3 and 6
measure: Work and Social Adjustment Scale - Youth (Parent version)
timeFrame: Months 3 and 6
measure: iBelong
timeFrame: Baseline, Month 6
measure: Joy
timeFrame: Months 3 and 6
measure: Data Archive Collection Items
timeFrame: Baseline, Months 3 and 6
Locations:
city: New York
country: United States
facility: Kings County Hospital
state: New York
Study officials:
affiliation: New York University
name: Michael A Lindsey, PhD
role: PRINCIPAL_INVESTIGATOR
References: