跳至主要内容
临床试验/NCT07150832
NCT07150832招募中不适用

I-CARE: Efficacy of a Digital Health Intervention to Reduce Suicidal Ideation During Psychiatric Boarding

Dartmouth-Hitchcock Medical Center8 个研究点 分布在 1 个国家目标入组 173 人开始时间: 2025年10月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
173
试验地点
8
主要终点
Depression Anxiety Stress Scales Youth Version (DASS-Y )

研究概览

简要总结

When presenting to an ED with suicide, self-harm or other mental health crises, youth may also experience "boarding", which is defined by the Joint Commission as "the practice of holding patients in the ED or another temporary location after the decision to admit or transfer has been made." A recent national survey of 88 US acute care hospitals conducted by our research team found that 98.9% of hospitals were boarding youth awaiting psychiatric hospitalization, for an average of 2-3 days. However, as illustrated in a systemic review, little research has focused on developing interventions to support youth during this highly vulnerable time. 3

I-CARE is a modular, blended digital health intervention facilitated by individuals who are not mental health clinical staff to teach youth evidence-based psychosocial skills during the boarding period. This study will evaluate I-CARE's efficacy using a patient-level randomized clinical trial (RCT), randomizing youth to receive standard safety supervision or I-CARE in addition to standard safety supervision. If found to the efficacious, I-CARE could be scaled-up in new settings with limited resources and has the potential to significantly improve the quality of care received by youth experiencing boarding.

详细描述

Suicide is the second leading cause of death among adolescents; from 2007 to 2017 suicide deaths tripled in youth 10 to 14 years. Emergency departments (EDs) at acute care hospitals increasingly serve as portals of care for youth with suicidal ideation or attempt. When these youth are deemed to require psychiatric hospitalization, the demand for beds often exceeds supply, leading to psychiatric boarding. To address this gap, a multidisciplinary team including pediatricians, psychologists and patient partners developed a modular digital intervention and associated training materials to deliver evidence-based psychosocial skills to youth during boarding. This program, entitled I-CARE (Improving Care, Accelerating Recovery & Education), consists of 7 web-based animated videos and workbook exercises, facilitated by licensed nursing assistants who provide 1-on-1 safety supervision during boarding. Given that 1-on-1 safety supervision is the current standard of care at most hospitals, I-CARE requires minimal additional resources beyond those already available in these settings. The psychosocial skills included in I-CARE are grounded in cognitive behavioral therapy and were prioritized through a rigorous Delphi process evaluating their importance and feasibility to deliver during psychiatric boarding.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
12 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Adolescents of any sex and gender, aged 12-17 years at ED visit or hospital encounter
  • Presenting with suicide attempt or ideation, or self-harm
  • Medically stable
  • English-speaking
  • Awaiting transfer for inpatient psychiatric care or disposition.

排除标准

  • Cognitive or developmental delays precluding participation (intellectual functioning <12 years of age)
  • Behavioral limitations that preclude program participation
  • Active psychosis
  • Legal parent/caregiver unable to speak English or unavailable to provide consent (e.g. Wards of the State)

结局指标

主要结局

Depression Anxiety Stress Scales Youth Version (DASS-Y )

时间窗: Baseline/hospital admission (T1), hospital discharge/approximately 72 hours after admission (T2), and 30 days (T3), 60 days (T4), and 90 days (T5) post-discharge

The DASS-Y is a 21-item, youth-oriented validated measure that generates an aggregate assessment of emotional distress and sub-measures of depression, anxiety, and stress. Each item is self-reported on a 4-point Likert scale ranging from 0 (Did not apply to me at all) to 3 (Applied to me very much, or most of the time).

9-item Concise Health Risk Tracking - Self-Report (CHRT-SR9)

时间窗: Baseline/hospital admission (T1), hospital discharge/approximately 72 hours after admission (T2), and 30 days (T3), 60 days (T4), and 90 days (T5) postdischarge

The Concise Health Risk Tracking (CHRT) is a 9-item survey that assesses suicidal thoughts and behaviors in the past week, with response options ranging 0-4. Total scores range 0-36, with higher scores indicating more severe suicidality.

Harkavy-Asnis Suicide Scale (HASS)

时间窗: Time Frame: 30 days (T3), 60 days (T4), and 90 days (T5) postdischarge

The HASS consists of 21 self-report items that cover the range of suicidal ideation and attempts, including both passive and active ideation. Responses on each item range 0-4; total scores range 0-84, with higher scores indicating more severe suicidality. The study will use only the 2 questions that inquire about suicide attempts.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

JoAnna K. Leyenaar

Professor of Pediatrics, Professor of The Dartmouth Institute

Trustees of Dartmouth College

研究点 (8)

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