Mental Health DisorderNCT07150832
Efficacy of the I-CARE Digital Health Intervention
A study testing Improving Care, Accelerating Recovery & Education (ICARE) in people with Mental Health Disorder and Suicide Attempt, run by Dartmouth-Hitchcock Medical Center at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Mental Health Disorder, Suicide Attempt, Suicidal Ideation
- What is being tested?
- Improving Care, Accelerating Recovery & Education (ICARE)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 173 participants
- Where
- 4 sitesUnited States
- Study dates
- 6 Oct 2025to 30 Jun 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Not yet recruiting
Dartmouth College
Hanover, New Hampshire, 03755
Alistar J. O'Malley, MS, PhD, 603-646-5653, james.omalley@dartmouth.edu
- Not yet recruiting
Dartmouth Health
Lebanon, New Hampshire, 03756
JoAnna K. Leyenaar, MD, PhD, MPH, 603-650-5454, JoAnna.K.Leyenaar@Dartmouth.edu
- Recruiting
Yale
New Haven, Connecticut, 06520
Jaspreet Loyal, MD, MS, 475-441-2333, jaspreet.loyal@yale.edu
- Recruiting
Weill Cornell Medicine
New York, New York, 10065
Alexandra Huttle, MD, MSc, 212-746-0921, alh9128@med.cornell.edu
About this study
Official title: I-CARE: Efficacy of a Digital Health Intervention to Reduce Suicidal Ideation During Psychiatric Boarding
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.
Read the 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.
- Being tested
- Improving Care, Accelerating Recovery & Education (ICARE)
- Keywords
- Children, Adolescents, Emergency Department, Mental Health Boarding, Psychosocial Skills
- Medical subject headings
- Mental Disorders, Suicide, Attempted, Suicidal Ideation, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Improving Care, Accelerating Recovery & Education (ICARE)Behavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: Time Frame: 30 days (T3), 60 days (T4), and 90 days (T5) postdischarge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start6 Oct 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 173 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Yale University, Weill Medical College of Cornell University, Dartmouth College
- Responsible party
- Principal investigator, JoAnna K. Leyenaar, Trustees of Dartmouth College
- Investigators
- JoAnna K. Leyenaar, MD, PhD, MPH, Principal investigator, Dartmouth College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07150832
- Sponsor's protocol ID
- LSRG-1-094-23
- Other IDs
- STUDY00033318, 2000039368, FWA00000093, STUDY02002242
- Status last verified
- Sep 2026
- First submitted
- 28 Aug 2025
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be uploaded into the NIMH Data Archive (NDA). Data will be collected from approximately 173 adolescents 12-17 years of age. Measures include: 1. Depression, Anxiety, and Stress Scale - Youth version (DASS-Y) 2. Harkavy-Asnis Suicide Scale (HASS) - Suicide Attempt module 3. Concise-Health Risk Tracking-Self Report (CHRT) 4. Revised Children's Anxiety and Depression Scale-25 (RCADS-25)