Efficacy of the I-CARE Digital Health Intervention

NCT07150832 | Recruiting DMC

• 5 other identifiers: LSRG-1-094-23STUDY000333182000039368FWA00000093STUDY02002242
• Study Type: interventional
• Target: 173
• Locations: 1 country
• Sites: 4

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.

Conditions

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

Keywords

Children; Adolescents; Emergency Department; Mental Health Boarding; Psychosocial Skills

Outcome Measures

Primary Outcomes (3)

• Depression Anxiety Stress Scales Youth Version (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), 60 days (T4), and 90 days (T5) post-discharge

• 9-item Concise Health Risk Tracking - Self-Report (CHRT-SR9)

  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), 60 days (T4), and 90 days (T5) postdischarge

• Harkavy-Asnis Suicide Scale (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.

  Time Frame: 30 days (T3), 60 days (T4), and 90 days (T5) postdischarge

Study Arms (2)

I-CARE

EXPERIMENTAL

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.

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

Safety Supervision

NO INTERVENTION

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

Interventions

Improving Care, Accelerating Recovery & Education (ICARE) 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.

I-CARE

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• Yale University: collaborator
• Weill Medical College of Cornell University: collaborator
• Dartmouth College: collaborator

Study Sites (4)

Yale

New Haven, Connecticut, 06520, United States

RECRUITING

Dartmouth College

Hanover, New Hampshire, 03755, United States

NOT YET RECRUITING

Dartmouth Health

Lebanon, New Hampshire, 03756, United States

NOT YET RECRUITING

Weill Cornell Medicine

New York, New York, 10065, United States

RECRUITING

MeSH Terms

Conditions

Mental Disorders; Suicide, Attempted; Suicidal Ideation; Emergencies

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• JoAnna K. Leyenaar, MD, PhD, MPH

  Dartmouth College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie C. Acquilano, MA

CONTACT

603-848-4742; stephanie.acquilano@dartmouth.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics, Professor of The Dartmouth Institute

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 2, 2025
• Study Start: October 6, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: October 31, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: All data will be deposited to NDA starting 12 months after the award begins and will be deposited every six months thereafter following the usual NDA data submission dates.
• Access Criteria: All those with access to the NDA will have access to our data.

Locations

US (4)