I-CARE: The Effectiveness of a Modular Digital Intervention to Reduce Suicidal Ideation and Emotional Distress During Pediatric Psychiatric Boarding
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 109
- 试验地点
- 3
- 主要终点
- Change in Depression, Anxiety, and Stress Scale, Youth (DASS-Y) Total Score
研究概览
简要总结
The goal of this clinical trial is to test the I-CARE program in children who are in a medical hospital awaiting inpatient mental health treatment. The main questions it aims to answer are:
- Can the I-CARE program be used at the medical hospitals and do the patients and hospital staff like the program?
- Does the I-CARE program lower patients' emotional distress, thoughts about suicide or suicide attempts?
Patients will complete as many of the 7 I-CARE videos as possible during their stay at the medical hospital and fill out online surveys. There are workbook activities that go with each I-CARE video. A hospital staff member will help the patient do the videos and workbook activities.
详细描述
The COVID-19 pandemic has contributed to a dramatic and unprecedented rise in pediatric mental health conditions, with rates of depression and anxiety doubling from pre-pandemic estimates. These increases exacerbate decades-long trends of increasing youth suicidality. 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.
Aim 1:
Adapt and refine I-CARE training and implementation materials, taking into account variation in hospital resources and boarding locations while maintaining implementation fidelity.
Aim 2:
Using an open pilot/case series design, assess I-CARE feasibility and engagement of target mechanisms from the perspectives of youth, caregivers, and clinicians using a mixed-methods approach.
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
- 否
入选标准
- •Adolescents aged 12-17 years
- •Ability to speak and complete surveys in English
- •Presented to ED with suicidal ideation or attempt
- •Awaiting psychiatric disposition
- •Receiving one-on-one safety supervision
- •Medically stable
排除标准
- •Cognitive or developmental delays that preclude program participation based on clinical team assessment
- •Diagnosis of psychosis
- •Primary reason for hospitalization or ED visit is an eating disorder
- •Parent/guardian not able to provide consent in English
- •Admission or transfer for psychiatric care anticipated on the first day of potential enrollment
- •Clinical team concern for patient or staff safety based upon active behavioral concerns
- •In child protective custody/ward of the state
研究组 & 干预措施
I-CARE
I-CARE (Improving Care, Accelerating Recovery & Education) is a quality improvement program designed to deliver evidence-based psychosocial skills to adolescents during mental health boarding. The program consists of 7 web-based animated videos and workbook exercises, facilitated by licensed nursing assistants/behavioral health technicians/safety attendants who provide one-on-one safety supervision during boarding. I-CARE will be offered to all eligible adolescents who are boarding and only those who agree to participate in a program evaluation will be involved in the research component.
干预措施: Improving Care, Accelerating Recovery & Education (ICARE) (Behavioral)
Usual Care
These hospitals currently offer basic safety supervision and medical monitoring for adolescents during mental health boarding. This is the "usual care" condition.
结局指标
主要结局
Change in Depression, Anxiety, and Stress Scale, Youth (DASS-Y) Total Score
时间窗: Baseline/hospital admission (T1), hospital discharge/approximately 72 hours after admission (T2), and 30 days (T3), 3 months (T4), and 6 months (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).
Change in Concise Health Risk Tracking, Self-Report (CHRT-SR-9) Total Score
时间窗: Baseline/hospital admission (T1), hospital discharge/approximately 72 hours after admission (T2), and 30 days (T3), 3 months (T4), and 6 months (T5) postdischarge
The Concise Health Risk Tracking, Self-Report (CHRT-SR-9) 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. The CHRT-SR-9 includes 4 sub-measures: Pessimism, Helplessness, Despair \& Suicidal Thoughts.
Change in Harkavy-Asnis Suicide Scale (HASS), Suicide Attempt Module (HASS-SA)
时间窗: 30 days (T3), 3 months (T4), and 6 months (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 HASS-SA, the 2 questions that inquire about suicide attempts.
次要结局
- Disposition change(Hospital discharge/approximately 72 hours after admission (T2))
- DASS-Y Depression Subscale(Baseline/hospital admission (T1), hospital discharge/approximately 72 hours after admission (T2), and 30 days (T3), 3 months (T4), and 6 months (T5) post-discharge)
- DASS-Y Anxiety Subscale(Baseline/hospital admission (T1), hospital discharge/approximately 72 hours after admission (T2), and 30 days (T3), 3 months (T4), and 6 months (T5) post-discharge)
- DASS-Y Stress Subscale(Baseline/hospital admission (T1), hospital discharge/approximately 72 hours after admission (T2), and 30 days (T3), 3 months (T4), and 6 months (T5) post-discharge)
- CHRT-SR-9 Pessimism Subscale(Baseline/hospital admission (T1), hospital discharge/approximately 72 hours after admission (T2), and 30 days (T3), 3 months (T4), and 6 months (T5) post-discharge)
- CHRT-SR-9 Helplessness Subscale(Baseline/hospital admission (T1), hospital discharge/approximately 72 hours after admission (T2), and 30 days (T3), 3 months (T4), and 6 months (T5) post-discharge)
- CHRT-SR-9 Despair Subscale(Baseline/hospital admission (T1), hospital discharge/approximately 72 hours after admission (T2), and 30 days (T3), 3 months (T4), and 6 months (T5) post-discharge)
- CHRT-SR-9 Suicidal Thoughts Subscale(Baseline/hospital admission (T1), hospital discharge/approximately 72 hours after admission (T2), and 30 days (T3), 3 months (T4), and 6 months (T5) post-discharge)
研究者
JoAnna K. Leyenaar
Principal Investigator; Staff Physician; Professor of Pediatrics
Dartmouth-Hitchcock Medical Center