Improving Care, Accelerating Recovery and Education (NCT06233747) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Improving Care, Accelerating Recovery and Education
United States109 participantsStarted 2024-02-29
Plain-language summary
The goal of this clinical trial is to test the I-CARE program in children who are in a medical hospital awaiting inpatient mental health treatment. The main questions it aims to answer are:
* Can the I-CARE program be used at the medical hospitals and do the patients and hospital staff like the program?
* Does the I-CARE program lower patients' emotional distress, thoughts about suicide or suicide attempts?
Patients will complete as many of the 7 I-CARE videos as possible during their stay at the medical hospital and fill out online surveys. There are workbook activities that go with each I-CARE video. A hospital staff member will help the patient do the videos and workbook activities.
Who can participate
Age range
12 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adolescents aged 12-17 years
* Ability to speak and complete surveys in English
* Presented to ED with suicidal ideation or attempt
* Awaiting psychiatric disposition
* Receiving one-on-one safety supervision
* Medically stable
Exclusion Criteria:
* Cognitive or developmental delays that preclude program participation based on clinical team assessment
* Diagnosis of psychosis
* Primary reason for hospitalization or ED visit is an eating disorder
* Parent/guardian not able to provide consent in English
* Admission or transfer for psychiatric care anticipated on the first day of potential enrollment
* Clinical team concern for patient or staff safety based upon active behavioral concerns
* In child protective custody/ward of the state
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Depression, Anxiety, and Stress Scale, Youth (DASS-Y) Total Score
Timeframe: Baseline/hospital admission (T1), hospital discharge/approximately 72 hours after admission (T2), and 30 days (T3), 3 months (T4), and 6 months (T5) post-discharge
2
Change in Concise Health Risk Tracking, Self-Report (CHRT-SR-9) Total Score
Timeframe: Baseline/hospital admission (T1), hospital discharge/approximately 72 hours after admission (T2), and 30 days (T3), 3 months (T4), and 6 months (T5) postdischarge
3
Change in Harkavy-Asnis Suicide Scale (HASS), Suicide Attempt Module (HASS-SA)
Timeframe: 30 days (T3), 3 months (T4), and 6 months (T5) postdischarge