Efficacy of the I-CARE Digital Health Intervention

Not Applicable

Not yet recruiting

• Conditions: Mental Health Disorder; Suicide Attempt; Suicidal Ideation; Emergency Psychiatric

• Registration Number: NCT07150832
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

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.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-28
• Study First Submitted QC: 2025-08-28
• Last Update Submitted: 2025-08-28
• Study First Posted: 2025-09-02
• Last Update Posted: 2025-09-02
• Study Start: 2025-10-01
• Primary Completion: 2027-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 173

Inclusion Criteria

For Aim 1 at Weill-Cornell and Yale, study participants will include English-speaking youth aged 12-17 years with suicidal ideation and/or attempt or self-harm who are in the ED or inpatient unit while awaiting transfer for inpatient psychiatric care or disposition planning.

Exclusion Criteria

(a) cognitive or developmental delays precluding participation (intellectual functioning <12 years of age), (b) behavioral limitations that preclude program participation, (c) active psychosis, and (d) legal parent/caregiver unavailable to provide consent (e.g. Wards of the State).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Depression Anxiety Stress Scales Youth Version (DASS-Y )	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	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).
9-item Concise Health Risk Tracking - Self-Report (CHRT-SR9)	Baseline/hospital admission (T1), hospital discharge/approximately 72 hours after admission (T2), and 30 days (T3), 60 days (T4), and 90 days (T5) postdischarge	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.
Harkavy-Asnis Suicide Scale (HASS)	Time Frame: 30 days (T3), 60 days (T4), and 90 days (T5) postdischarge	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.

Trial Locations

Locations (4)

Yale; 🇺🇸 New Haven, Connecticut, United States

Dartmouth College; 🇺🇸 Hanover, New Hampshire, United States

Dartmouth Health; 🇺🇸 Lebanon, New Hampshire, United States

Weill Cornell Medicine; 🇺🇸 New York, New York, United States