Improving Care, Accelerating Recovery and Education (I-CARE)

Dartmouth Health

Status: Enrolling

Conditions: Suicide Attempt; Suicidal Ideation; Mental Health Disorder; Emergency Psychiatric

Treatments: Behavioral: Improving Care, Accelerating Recovery & Education (ICARE)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06233747

RF1MH134626 (U.S. NIH Grant/Contract)

STUDY02002045

Details and patient eligibility

About

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.

Full 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.

Enrollment: 109 estimated patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Study participants will include English-speaking youth 12-17 years of age with suicidal ideation and/or attempt who are experiencing psychiatric boarding while awaiting transfer for inpatient psychiatric care and who are supervised one-on-one by a safety attendant during this time period. Youth will be eligible on the first full day following hospital presentation and/or medical clearance.

Exclusion criteria

1. cognitive or developmental delays that preclude program participation based on clinical team assessment;
2. diagnosis of psychosis or active mania,
3. primary reason for hospitalization or ED visit is an eating disorder,
4. parent/guardian not fluent in English or Spanish, or
5. admission or transfer for psychiatric care anticipated on the first day of potential enrollment
6. Clinical team concern for patient or staff safety based upon active behavioral concerns

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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109 participants in 2 patient groups

I-CARE

Experimental group

Description:

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.

Treatment:

Behavioral: Improving Care, Accelerating Recovery & Education (ICARE)

Usual Care

No Intervention group

Description:

These hospitals currently offer basic safety supervision and medical monitoring for adolescents during mental health boarding. This is the "usual care" condition.