Clinical trial NCT06233747: Improving Care, Accelerating Recovery and Education
Official title: I-CARE: The Effectiveness of a Modular Digital Intervention to Reduce Suicidal Ideation and Emotional Distress During Pediatric Psychiatric Boarding
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Health Disorder
Suicide Attempt
Suicidal Ideation
Emergency Psychiatric
Keywords: children
adolescents
emergency department
psychosocial skills
mental health boarding
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Dartmouth College
name: Children's Hospital of Philadelphia
name: University of Vermont
First posted: 2024-01-31
Enrollment: 109
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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 fluent in English (or Spanish - future plan)
* 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

Primary outcomes:
measure: Change in Depression, Anxiety, and Stress Scale, Youth (DASS-Y)
timeFrame: 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
measure: Change in Harkavy-Asnis Suicide Scale (HASS), Suicide Attempt Module (HASS)
timeFrame: 30 days (T3), 3 months (T4), and 6 months (T5) postdischarge
measure: Change in Concise Health Risk Tracking (CHRT)
timeFrame: Baseline/hospital admission (T1), hospital discharge/approximately 72 hours after admission (T2), and 30 days (T3), 3 months (T4), and 6 months (T5) postdischarge
Secondary outcomes:
measure: Change in Efficacy to Cope with Suicidal Thoughts and Urges Scale
timeFrame: Baseline/hospital admission (T1), hospital discharge/approximately 72 hours after admission (T2), and 30 days (T3), 3 months (T4), and 6 months (T5) postdischarge
measure: Change in The Children's Hope Scale
timeFrame: Baseline/hospital admission (T1), hospital discharge/approximately 72 hours after admission (T2), and 30 days (T3), 3 months (T4), and 6 months (T5) postdischarge
measure: Change in My Thoughts About Therapy (MTT; REACH Framework Expectancy Scale)
timeFrame: Baseline/hospital admission (T1), hospital discharge/approximately 72 hours after admission (T2), and 30 days (T3), 3 months (T4), and 6 months (T5) postdischarge
measure: Change in Cunningham Treatment Engagement Readiness to Change Subscale
timeFrame: Baseline/hospital admission (T1), hospital discharge/approximately 72 hours after admission (T2), and 30 days (T3), 3 months (T4), and 6 months (T5) postdischarge
measure: Disposition change
timeFrame: Hospital discharge/approximately 72 hours after admission (T2)
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Burlington
country: United States
facility: University of Vermont Medical Center
state: Vermont
Study officials:
affiliation: Dartmouth Health
name: JoAnna K Leyenaar, MD, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: