Improving Care, Accelerating Recovery and Education

Suicidal Ideation Clinical Trial

— I-CARE  

Official title:

I-CARE: The Effectiveness of a Modular Digital Intervention to Reduce Suicidal Ideation and Emotional Distress During Pediatric Psychiatric Boarding

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06233747
• Other study ID #: STUDY02002045
• Secondary ID: RF1MH134626
• Status: Recruiting
• Phase: N/A
• Start date: February 29, 2024
• Est. completion date: July 31, 2025

Study information

• Verified date: March 2024
• Source: Dartmouth-Hitchcock Medical Center
• Contact: Stephanie C. Acquilano, MA
• Phone: 603-848-4742
• Email: stephanie.acquilano[@]dartmouth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 109
• Est. completion date: July 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Emergency Psychiatric
• Mental Disorders
• Mental Health Disorder
• Suicidal Ideation
• Suicide
• Suicide Attempt
• Suicide, Attempted

Intervention

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

Locations

Country	Name	City	State
United States	University of Vermont Medical Center	Burlington	Vermont
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (5)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	Children's Hospital of Philadelphia, Dartmouth College, National Institute of Mental Health (NIMH), University of Vermont Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Depression, Anxiety, and Stress Scale, Youth (DASS-Y)	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).	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
Primary	Change in Harkavy-Asnis Suicide Scale (HASS), Suicide Attempt Module (HASS)	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.	30 days (T3), 3 months (T4), and 6 months (T5) postdischarge
Primary	Change in Concise Health Risk Tracking (CHRT)	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.	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	Change in Efficacy to Cope with Suicidal Thoughts and Urges Scale	The Efficacy to Cope with Suicidal Thoughts and Urges Scale was designed to measure children's abilities to manage suicide-related thoughts and impulses. It contains 10 coping skills and children rate their confidence in their ability to use each coping skill to manage their suicidality. Responses range from 0 to 10 with 0 = Not at all confident, 5 = Somewhat confident, and 10 = Extremely confident.	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	Change in The Children's Hope Scale	The Children's Hope Scale is a 6-item self-report measure of hope. Response options range from; 1 to 6, with 1 = None of the time and 6 = All of the time.	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	Change in My Thoughts About Therapy (MTT; REACH Framework Expectancy Scale)	The MTT measures five factors of treatment engagement (Relationship, Expectancy, Attendance, Clarity, and Homework); the study will use the Expectancy scale only. Items are answered using a 4-point Likert-scale, with from 0 = "strongly disagree" and 3 = "strongly agree".	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	Change in Cunningham Treatment Engagement Readiness to Change Subscale	The Cunningham Treatment Engagement Readiness to Change Subscale measures clients' level readiness to change with regard to treatment and behaviors. It contains 5 questions answered on a 5-point Likert-scale, from "strongly disagree" to "strongly agree".	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	Disposition change	This is a dichotomous variable defined as discharge to home instead of inpatient psychiatric care and will be gathered from electronic medical records.	Hospital discharge/approximately 72 hours after admission (T2)