Efficacy of the I-CARE Digital Health Intervention

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Dartmouth-Hitchcock Medical Center
Study ID
NCT07150832
Status
Recruiting

Conditions

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

Eligibility Criteria

Sex
ALL
Age
12 Years - 17 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Oct 6, 2025
Status verified
Aug 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
173 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: 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.
  • No Intervention: Safety Supervision
    These hospitals currently offer basic safety supervision and medical monitoring for adolescents during mental health boarding. This is the "usual care" condition.

Primary Outcome Measure

Depression Anxiety Stress Scales Youth Version (DASS-Y ) [ Time Frame: 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 ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
YaleNew HavenConnecticut06520
Jaspreet Loyal, MD, MS
475-441-2333
Dartmouth CollegeHanoverNew Hampshire03755
Alistar J. O'Malley, MS, PhD
603-646-5653
Dartmouth HealthLebanonNew Hampshire03756
JoAnna K. Leyenaar, MD, PhD, MPH
603-650-5454
Weill Cornell MedicineNew YorkNew York10065
Alexandra Huttle, MD, MSc
212-746-0921

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