跳至主要内容
临床试验/NCT05654207
NCT05654207招募中不适用

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

New York University2 个研究点 分布在 1 个国家目标入组 2,200 人开始时间: 2024年4月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
2,200
试验地点
2
主要终点
Columbia-Suicide Severity Rating Scale

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
12 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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 or available to consent remotely (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

排除标准

  • adolescent and parent/guardians:
  • Adolescent is medically unstable
  • Adolescent present with severe cognitive impairment
  • Parents are not present in the ED, unable to consent remotely, and not able 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)

研究组 & 干预措施

WeCare

Experimental

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

干预措施: WeCare (Behavioral)

Usual Services

No Intervention

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

结局指标

主要结局

Columbia-Suicide Severity Rating Scale

时间窗: 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).

Mental Health Outpatient Visits (Electronic Medical Record)

时间窗: 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.

次要结局

  • Caregiver Knowledge of Mental Health Services (Therapy Survey)(Baseline, Months 3 and 6)
  • Peer Victimization and Perpetration(Baseline, Months 3 and 6)
  • Barriers(Baseline, Months 3 and 6)
  • ED STARS Mental Health Service Use(Baseline, Months 3 and 6)
  • Attitudes Toward Psychological Help Scale(Baseline, Months 3 and 6)
  • Hopelessness(Baseline, Months 3 and 6)
  • Parent-Family Connectedness Scale(Baseline, Months 3 and 6)
  • Stages of Change(Baseline, Months 3 and 6)
  • Barriers to Treatment Participation Scale(Baseline, Months 3 and 6)
  • How I Feel about Friends(Baseline, Months 3 and 6)
  • Urgency Premeditated Perseverance Sensation Seeking Subscale(Baseline, Months 3 and 6)
  • Mental Health Service Use(Baseline, Months 3 and 6)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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