Efficacy of the I-CARE Digital Health Intervention

NCT ID: NCT07150832

Last Updated: 2025-10-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 173 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-06
• Study Completion Date: 2027-06-30

Brief Summary

When presenting to an ED with suicide, self-harm or other mental health crises, youth may also experience "boarding", which is defined by the Joint Commission as "the practice of holding patients in the ED or another temporary location after the decision to admit or transfer has been made." A recent national survey of 88 US acute care hospitals conducted by our research team found that 98.9% of hospitals were boarding youth awaiting psychiatric hospitalization, for an average of 2-3 days. However, as illustrated in a systemic review, little research has focused on developing interventions to support youth during this highly vulnerable time. 3

I-CARE is a modular, blended digital health intervention facilitated by individuals who are not mental health clinical staff to teach youth evidence-based psychosocial skills during the boarding period. This study will evaluate I-CARE's efficacy using a patient-level randomized clinical trial (RCT), randomizing youth to receive standard safety supervision or I-CARE in addition to standard safety supervision. If found to the efficacious, I-CARE could be scaled-up in new settings with limited resources and has the potential to significantly improve the quality of care received by youth experiencing boarding.

Detailed Description

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

I-CARE

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 Type: EXPERIMENTAL

Improving Care, Accelerating Recovery & Education (ICARE)

Intervention Type: BEHAVIORAL

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 individuals who are not mental health professionals. All modules are grounded in evidence-based practices, such as cognitive-behavioral therapy and dialectical behavior therapy.

Safety Supervision

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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 individuals who are not mental health professionals. All modules are grounded in evidence-based practices, such as cognitive-behavioral therapy and dialectical behavior therapy.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Adolescents of any sex and gender, aged 12-17 years at ED visit or hospital encounter
• Presenting with suicide attempt or ideation, or self-harm
• Medically stable
• English-speaking
• Awaiting transfer for inpatient psychiatric care or disposition.

Exclusion Criteria

• Cognitive or developmental delays precluding participation (intellectual functioning <12 years of age)
• Behavioral limitations that preclude program participation
• Active psychosis
• Legal parent/caregiver unable to speak English or unavailable to provide consent (e.g. Wards of the State)

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: collaborator

Dartmouth College

OTHER

Sponsor Role: collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role: lead

Responsible Party

JoAnna K. Leyenaar

Professor of Pediatrics, Professor of The Dartmouth Institute

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

JoAnna K. Leyenaar, MD, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Dartmouth College

Locations

Yale

New Haven, Connecticut, United States

Site Status: RECRUITING

Dartmouth College

Hanover, New Hampshire, United States

Site Status: NOT_YET_RECRUITING

Dartmouth Health

Lebanon, New Hampshire, United States

Site Status: NOT_YET_RECRUITING

Weill Cornell Medicine

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Stephanie C. Acquilano, MA

Role: CONTACT

stephanie.acquilano@dartmouth.edu

603-848-4742

Facility Contacts

Jaspreet Loyal, MD, MS

Role: primary

jaspreet.loyal@yale.edu

475-441-2333

Alistar J. O'Malley, MS, PhD

Role: primary

james.omalley@dartmouth.edu

603-646-5653

JoAnna K. Leyenaar, MD, PhD, MPH

Role: primary

JoAnna.K.Leyenaar@Dartmouth.edu

603-650-5454

Alexandra Huttle, MD, MSc

Role: primary

alh9128@med.cornell.edu

212-746-0921

Other Identifiers

STUDY00033318

Identifier Type: OTHER

Identifier Source: secondary_id

2000039368

Identifier Type: OTHER

Identifier Source: secondary_id

FWA00000093

Identifier Type: OTHER

Identifier Source: secondary_id

STUDY02002242

Identifier Type: OTHER

Identifier Source: secondary_id

LSRG-1-094-23

Identifier Type: -

Identifier Source: org_study_id