Suicidal Ideation Clinical Trial
— I-CAREOfficial title:
I-CARE: The Effectiveness of a Modular Digital Intervention to Reduce Suicidal Ideation and Emotional Distress During Pediatric Psychiatric Boarding
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.
Status | Recruiting |
Enrollment | 109 |
Est. completion date | July 31, 2025 |
Est. primary completion date | June 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 17 Years |
Eligibility | Inclusion Criteria: Study participants will include English-speaking youth 12-17 years of age with suicidal ideation and/or attempt who are experiencing psychiatric boarding while awaiting transfer for inpatient psychiatric care and who are supervised one-on-one by a safety attendant during this time period. Youth will be eligible on the first full day following hospital presentation and/or medical clearance. Exclusion Criteria: 1. cognitive or developmental delays that preclude program participation based on clinical team assessment; 2. diagnosis of psychosis or active mania, 3. primary reason for hospitalization or ED visit is an eating disorder, 4. parent/guardian not fluent in English or Spanish, or 5. admission or transfer for psychiatric care anticipated on the first day of potential enrollment 6. Clinical team concern for patient or staff safety based upon active behavioral concerns |
Country | Name | City | State |
---|---|---|---|
United States | University of Vermont Medical Center | Burlington | Vermont |
United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Dartmouth-Hitchcock Medical Center | Children's Hospital of Philadelphia, Dartmouth College, National Institute of Mental Health (NIMH), University of Vermont Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Depression, Anxiety, and Stress Scale, Youth (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). | 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 | |
Primary | Change in Harkavy-Asnis Suicide Scale (HASS), Suicide Attempt Module (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. | 30 days (T3), 3 months (T4), and 6 months (T5) postdischarge | |
Primary | Change in Concise Health Risk Tracking (CHRT) | 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. | Baseline/hospital admission (T1), hospital discharge/approximately 72 hours after admission (T2), and 30 days (T3), 3 months (T4), and 6 months (T5) postdischarge | |
Secondary | Change in Efficacy to Cope with Suicidal Thoughts and Urges Scale | The Efficacy to Cope with Suicidal Thoughts and Urges Scale was designed to measure children's abilities to manage suicide-related thoughts and impulses. It contains 10 coping skills and children rate their confidence in their ability to use each coping skill to manage their suicidality. Responses range from 0 to 10 with 0 = Not at all confident, 5 = Somewhat confident, and 10 = Extremely confident. | Baseline/hospital admission (T1), hospital discharge/approximately 72 hours after admission (T2), and 30 days (T3), 3 months (T4), and 6 months (T5) postdischarge | |
Secondary | Change in The Children's Hope Scale | The Children's Hope Scale is a 6-item self-report measure of hope. Response options range from
1 to 6, with 1 = None of the time and 6 = All of the time. |
Baseline/hospital admission (T1), hospital discharge/approximately 72 hours after admission (T2), and 30 days (T3), 3 months (T4), and 6 months (T5) postdischarge | |
Secondary | Change in My Thoughts About Therapy (MTT; REACH Framework Expectancy Scale) | The MTT measures five factors of treatment engagement (Relationship, Expectancy, Attendance, Clarity, and Homework); the study will use the Expectancy scale only. Items are answered using a 4-point Likert-scale, with from 0 = "strongly disagree" and 3 = "strongly agree". | Baseline/hospital admission (T1), hospital discharge/approximately 72 hours after admission (T2), and 30 days (T3), 3 months (T4), and 6 months (T5) postdischarge | |
Secondary | Change in Cunningham Treatment Engagement Readiness to Change Subscale | The Cunningham Treatment Engagement Readiness to Change Subscale measures clients' level readiness to change with regard to treatment and behaviors. It contains 5 questions answered on a 5-point Likert-scale, from "strongly disagree" to "strongly agree". | Baseline/hospital admission (T1), hospital discharge/approximately 72 hours after admission (T2), and 30 days (T3), 3 months (T4), and 6 months (T5) postdischarge | |
Secondary | Disposition change | This is a dichotomous variable defined as discharge to home instead of inpatient psychiatric care and will be gathered from electronic medical records. | Hospital discharge/approximately 72 hours after admission (T2) |
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