WeCare: A System of Care for Black Youth

Suicidal Ideation Clinical Trial

— WeCare  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05654207
• Other study ID #: R01MH129786-01
• Status: Recruiting
• Phase: N/A
• Start date: April 8, 2024
• Est. completion date: March 31, 2027

Study information

• Verified date: February 2024
• Source: New York University
• Contact: Michael A Lindsey, PhD
• Phone: (212) 998-5959
• Email: michael.lindsey[@]nyu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2200
• Est. completion date: March 31, 2027
• Est. primary completion date: March 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 19 Years

Eligibility

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)

Related Conditions & MeSH terms

• Suicidal Ideation

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Kings County Hospital	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York University	University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Self-Efficacy	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
Other	YRBS-Alcohol	This measure assesses alcohol use.	Baseline, Months 3 and 6
Other	Drug Use Scale	This measure assesses adolescents' behaviors related to drug use.	Baseline, Months 3 and 6
Other	YRBS-Physical Fights	This single item measures frequency of physical fighting with a higher score indicating more incifidenst of fighting.	Baseline, Months 3 and 6
Other	Lethal Means Restriction	This measure assesses adolescents' access to lethal means (caregiver).	Baseline, Months 3 and 6
Other	Perceived Effectiveness of Treatment	This measure assesses perceived treatment effectiveness.	Baseline, Month 3
Other	Purpose in Life	This measure assesses adolescents' sense of purpose	Baseline, Months 3 and 6
Other	Thoughts about Mortality	This 5-item measure assesses beliefs and attitudes towards death.	Baseline, Month 6
Other	Suicidal Thoughts	This instruments measures the frequency of suicidal thoughts (only if participant responds YES to CSSRS 1 or 2).	Baseline, Months 3 and 6
Other	Exposure to Suicide	This measure assesses if adolescents had exposure to someone who attempted or died by suicide.	Baseline, Months 3 and 6
Other	Acquired Capability for Suicide	This 4-item measure assesses fearlessness of death.	Baseline, Months 3 and 6
Other	Demographics	This survey queries background characteristics (youth and caregiver versions).	Baseline, Months 3 and 6
Other	Gender Identity and Sexual Orientation	This survey queries adolescents' gender identity and sexual orientation.	Baseline, Months 3 and 6
Other	Purpose in Life (Expanded)	Expanded 6-item version of baseline purpose of life measure.	Months 3 and 6
Other	Regard of Identity	This 2-item measure assesses regard for racial identity.	Baseline, Months 3 and 6
Other	Social Competencies	This 3-item measure assesses social skills.	Baseline, Months 3 and 6
Other	Religious Identity	This survey queries religious identity (caregiver).	Baseline, Months 3 and 6
Other	Acculturation	This survey asks about acculturation to the United States (caregiver).	Baseline, Months 3 and 6
Other	Medical Mistrust	This 5-item measure assesses medical mistrust (caregiver). Higher score sindicate more medical mistrust (Minimum score: 6; Maximum score: 30).	Baseline, Months 3 and 6
Other	PedsQL	This measure assesses caregiver-reported issues youth face.	Baseline, Months 3 and 6
Other	ED-s Risk Survey (from ED-STARS)	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
Other	Work and Social Adjustment Scale - Youth (Parent version)	This measure assesses the impact of youth's problem to do certain day-to-day tasks (caregiver).	Months 3 and 6
Other	iBelong	This 6-item measure assesses adolescents' sense of belongingness. Higher scores indicate greater belongingness (Minimum 6; maximum 30).	Baseline, Month 6
Other	Joy	This 2-item measure assesses adolescents' sense of joy in their life.	Months 3 and 6
Other	Data Archive Collection Items	These items are shared data with the wider scientific community to assess mental and physical health concerns and wellbeing.	Baseline, Months 3 and 6
Primary	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
Primary	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	Attitudes Toward Psychological Help Scale	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
Secondary	Barriers	This 5-item measure captures barriers to MH treatment participation identified in PI Lindsey's prior work with Black youth and families. A higher score indicates a perception of more barriers to treatment (Minimum score: 5; Maximum score: 15).	Baseline, Months 3 and 6
Secondary	Caregiver Knowledge of Mental Health Services (Therapy Survey)	This measures expectations about treatment at a children's psychiatric clinic (caregiver).	Baseline, Months 3 and 6
Secondary	ED STARS Mental Health Service Use	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
Secondary	Hopelessness	This measure targets recent feelings of hopelessness and hope.	Baseline, Months 3 and 6
Secondary	Parent-Family Connectedness Scale	This measure assesses familial connectedness.	Baseline, Months 3 and 6
Secondary	How I Feel about Friends	This 2-ite, measure assesses peer connectedness. Higher scores indicate greater peer connectedness (Minimum score: 2; Maximum score: 10).	Baseline, Months 3 and 6
Secondary	Peer Victimization and Perpetration	This measure assesses bullying.	Baseline, Months 3 and 6
Secondary	Urgency Premeditated Perseverance Sensation Seeking Subscale	This measure assesses impulsivity.	Baseline, Months 3 and 6
Secondary	Mental Health Service Use	This measure assesses lifetime mental health service use (caregiver).	Baseline, Months 3 and 6
Secondary	Stages of Change	This 8-item measure assesses adolescents' willingness to change (Minimum score: 8; Maximum score: 32).	Baseline, Months 3 and 6
Secondary	Barriers to Treatment Participation Scale	This measure assesses barriers to treatment (caregiver).	Baseline, Months 3 and 6