I-CARE Digital Health Intervention for Suicidal Ideation

Recruiting at 3 trial locations

Overseen By Stephanie C. Acquilano, MA

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Dartmouth-Hitchcock Medical Center

Disqualifiers: Cognitive delays, Behavioral limitations, Active psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

173 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a digital program designed to support teens in emergency rooms who await mental health care after a suicide attempt or self-harm. The program, called I-CARE (Improving Care, Accelerating Recovery & Education), uses tablet-based videos and exercises to teach coping skills with help from non-clinical staff. Participants will either receive this program along with standard safety supervision or just the usual care. The trial seeks English-speaking teens aged 12-17 who have been medically cleared and are awaiting psychiatric care. As an unphased trial, this study offers teens a unique opportunity to access innovative support while contributing to important mental health research.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the I-CARE digital health intervention is safe for youth?

Research shows that the I-CARE program is a digital health tool designed to help teenagers learn important social and emotional skills while in a hospital emergency room. The program includes videos and workbook activities. Studies have examined how well young people can use and benefit from I-CARE.

Early results suggest that participants find I-CARE easy to use and enjoyable. This indicates that the program functions as intended and is generally well-received. No reports of negative effects have emerged, suggesting it is likely safe in this setting. The studies highlight the program's ability to reduce emotional stress and increase involvement, indicating positive results with few safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the I-CARE digital health intervention because it offers a fresh approach to managing suicidal ideation in adolescents. Unlike traditional treatments that often rely on face-to-face therapy or medication, I-CARE delivers evidence-based psychosocial skills through a tablet-based program. This innovative method includes seven web-based animated videos and workbook exercises, making mental health support more accessible and engaging, even in hospital settings where mental health resources may be limited. By leveraging technology, I-CARE aims to accelerate recovery and improve care during critical times, which could transform how support is provided to young individuals in crisis.

What evidence suggests that the I-CARE digital health intervention is effective for suicidal ideation?

Research has shown that the I-CARE program, which participants in this trial may receive, is designed to teach important life skills to young people during mental health crises. This online program uses videos and activities to help teenagers learn coping strategies while in emergency rooms. Studies have found that I-CARE can reduce emotional distress and increase openness to further mental health treatment. Participants have found it easy to use and helpful. These findings suggest that I-CARE could serve as a valuable support tool for young people in crisis. ^{1 2 3 4 5}

Who Is on the Research Team?

JoAnna K. Leyenaar, MD, PhD, MPH

Principal Investigator

Dartmouth College

Are You a Good Fit for This Trial?

This trial is for young individuals who come to the emergency department (ED) due to suicide attempts, self-harm, or other mental health crises and are waiting for psychiatric hospitalization. Participants must be experiencing 'boarding', which means they're held in the ED while awaiting further care.

Inclusion Criteria

I am a 12-17 year old who has thought about or attempted suicide, or self-harmed, currently in the ED or inpatient unit.

Exclusion Criteria

Active psychosis

Behavioral limitations that preclude program participation

Legal parent/caregiver unavailable to provide consent (e.g. Wards of the State)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-3 days

1 visit (in-person)

Boarding and Intervention

Participants receive either standard safety supervision or the I-CARE digital health intervention during psychiatric boarding

Approximately 72 hours

Continuous supervision during boarding

Follow-up

Participants are monitored for safety and effectiveness after discharge, with assessments at 30, 60, and 90 days post-discharge

90 days

3 visits (virtual or in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Improving Care, Accelerating Recovery & Education (ICARE)

Trial Overview The study tests I-CARE, a digital health intervention designed to teach psychosocial skills during boarding at the ED. Youth will either receive standard safety supervision alone or with I-CARE added on. The effectiveness of I-CARE will be determined by randomly assigning participants to one of these two options.

How Is the Trial Designed?

Group I: I-CARE Experimental Treatment 1 Intervention

I-CARE (Improving Care, Accelerating Recovery \& Education) is a tablet-based 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 non mental health professionals.

Group II: Safety Supervision Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Dartmouth-Hitchcock Medical Center

Lead Sponsor

Trials

548

Recruited

2,545,000+

Yale University

Collaborator

Trials

1,963

Recruited

3,046,000+

Weill Medical College of Cornell University

Collaborator

Trials

1,103

Recruited

1,157,000+

Dartmouth College

Collaborator

Trials

93

Recruited

1,415,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07150832

Efficacy of the I-CARE Digital Health Intervention I-CARE (Improving Care, Accelerating Recovery & Education) is a tablet-based program designed to deliver evidence-based psychosocial skills to adolescents ...

2. reporter.nih.gov reporter.nih.gov/search/Hg1SDhR1-EeS4pe2hKBYmw/project-details/10756733

I-CARE: The Effectiveness of a Modular Digital ... - NIH RePORTER PROJECT SUMMARY The COVID-19 pandemic has contributed to a substantial increase in suicidal ideation, suicide attempts, and suicide deaths among US adolescents.

3. jahonline.org jahonline.org/article/S1054-139X(23)00062-9/fulltext

I-CARE: Feasibility, Acceptability, and Appropriateness of a ... This pilot study describes changes in emotional distress, severity of illness, and readiness for engagement following I-CARE participation.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1054139X23000629

I-CARE: Feasibility, Acceptability, and Appropriateness of a ... I-CARE is a novel digital health intervention designed to teach evidence-based psychosocial skills to youth awaiting transfer for inpatient psychiatric care.

5. withpower.com withpower.com/trial/phase-mental-disorders-1-2024-8736f

I-CARE Program for Mental Health Disorders (I-CARE Trial) 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.