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) — BEHAVIORALI-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-CAREI-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 SupervisionThese 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
- Stephanie C. Acquilano, MA603-848-4742
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Yale | New Haven | Connecticut | 06520 | |
| Dartmouth College | Hanover | New Hampshire | 03755 | |
| Dartmouth Health | Lebanon | New Hampshire | 03756 | |
| Weill Cornell Medicine | New York | New York | 10065 |
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