Emergency Psychiatric, Mental Health Disorder, Suicidal Ideation, Suicide Attempt
Conditions
Keywords
children, adolescents, emergency department, psychosocial skills, mental health boarding
Brief summary
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.
Detailed description
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. Aim 3: Determine the preliminary effectiveness of I-CARE to reduce emotional distress and suicidal risk compared to usual care in youth experiencing boarding for suicidal ideation or attempt, and assess the effects of I-CARE on readiness for change, suicide-related coping, hope, and mental health treatment engagement.
Interventions
I-CARE is a brief, digital intervention designed for adolescents who are boarding in a medical hospital awaiting transfer to a psychiatric inpatient unit. It consists of 7 tablet-based animated video modules and workbook exercises, facilitated by licensed nursing assistants or other non-specialist clinicians who provide one-on-one safety supervision during boarding. All modules are grounded in evidence-based practices, such as cognitive-behavioral therapy and dialectical behavior therapy. Given that one-on-one safety supervision is the current standard of care during boarding, I-CARE requires minimal additional resources beyond those already available in acute care hospitals and builds on well established research demonstrating the effectiveness of task-sharing, the redistribution of tasks within the workforce, to address the shortage of mental health professionals.
Sponsors
Dartmouth-Hitchcock Medical Center
National Institute of Mental Health (NIMH)
Dartmouth College
Children's Hospital of Philadelphia
University of Vermont
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
This is a stepped wedge pilot study, in which 2 hospitals will be randomized to begin implementation of I-CARE at 2 different times within the 17-month study period. Both sites begin with an initial 3-month period of treatment-as-usual and the research team collects all outcome measures during this period, then 1 hospital will crossover to launch the I-CARE intervention and the other will launch 2 months later (continuing to provide treatment-as-usual in the interim). This may be considered a form of a parallel cluster study, in which one of the two hospitals is initially randomized to I-CARE while the other remains in the baseline/treatment-as-usual state.
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Depression, Anxiety, and Stress Scale, Youth (DASS-Y) Total Score | 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 | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | The DASS-Y Depression Subscale is a 7-item sub-measure of the 21-item DASS-Y. 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). |
| 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 | The DASS-Y Anxiety Subscale is a 7-item sub-measure of the 21-item DASS-Y. 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). |
| 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 | The DASS-Y Stress Subscale is a 7-item sub-measure of the 21-item DASS-Y. 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). |
| 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 | The CHRT-SR-9 Pessimism Subscale is a 2-item subscale of the CHRT-SR-9. It consists of the items "I feel as if things are never going to get better" and "I have no future," with response options ranging 0-4. |
| 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 | The CHRT-SR-9 Helplessness Subscale is a 2-item subscale of the CHRT-SR-9. It consists of the items "It seems as if I can do nothing right" and "Everything I do turns out wrong," with response options ranging 0-4. |
| 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 | The CHRT-SR-9 Despair Subscale is a 2-item subscale of the CHRT-SR-9. It consists of the items "I Feel that there is no reason to live" and "I Wish I could just go to sleep and not wake up," with response options ranging 0-4. |
| 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 | The CHRT-SR-9 Suicidal Thoughts Subscale is a 3-item subscale of the CHRT-SR-9. It consists of the items "I Have been having thoughts of killing myself," "I Have thoughts about how I might kill myself" and "I Have a plan to kill myself," with response options ranging 0-4. |
| Disposition change | Hospital discharge/approximately 72 hours after admission (T2) | This is a dichotomous variable defined as discharge to home instead of inpatient psychiatric care and will be gathered from electronic medical records. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJoAnna K Leyenaar, MD, PhD, MPH
Dartmouth Health
Outcome results
None listed