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Active, Not Recruiting

NCT Number: NCT06233747

Improving Care, Accelerating Recovery and Education

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Mental Health Disorder Behavior Behavioral Symptoms Disease Attributes Emergencies Emergency Psychiatric Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Self-Injurious Behavior Suicidal Ideation Suicide Suicide Attempt Suicide, Attempted

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States

Loading trial locations.

About this study

The COVID-19 pandemic has contributed to a dramatic and unprecedented rise in pediatric mental health conditions, with rates of depression and anxiety doubling from pre-pandemic estimates. These increases exacerbate decades-long trends of increasing youth suicidality. 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.

Aim 1:

Adapt and refine I-CARE training and implementation materials, taking into account variation in hospital resources and boarding locations while maintaining implementation fidelity.

Aim 2:

Using an open pilot/case series design, assess I-CARE feasibility and engagement of target mechanisms from the perspectives of youth, caregivers, and clinicians using a mixed-methods approach.

Aim 3:

Determine the preliminary effectiveness of I-CARE to reduce emotional distress and suicidal risk compared to usual care in youth experiencing boarding for suicidal ideation or attempt, and assess the effects of I-CARE on readiness for change, suicide-related coping, hope, and mental health treatment engagement.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Improving Care, Accelerating Recovery & Education (ICARE)

Behavioral

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 licensed nursing assistants or other non-specialist clinicians who provide one-on-one safety supervision during boarding. All modules are grounded in evidence-based practices, such as cognitive-behavioral therapy and dialectical behavior therapy. Given that one-on-one safety supervision is the current standard of care during boarding, I-CARE requires minimal additional resources beyond those already available in acute care hospitals and builds on well established research demonstrating the effectiveness of task-sharing, the redistribution of tasks within the workforce, to address the shortage of mental health professionals.

Primary outcomes

  1. Change in Depression, Anxiety, and Stress Scale, Youth (DASS-Y) Total Score

    Time frame: 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

    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).

  2. Change in Concise Health Risk Tracking, Self-Report (CHRT-SR-9) Total Score

    Time frame: Baseline/hospital admission (T1), hospital discharge/approximately 72 hours after admission (T2), and 30 days (T3), 3 months (T4), and 6 months (T5) postdischarge

    The Concise Health Risk Tracking, Self-Report (CHRT-SR-9) 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. The CHRT-SR-9 includes 4 sub-measures: Pessimism, Helplessness, Despair & Suicidal Thoughts.

  3. Change in Harkavy-Asnis Suicide Scale (HASS), Suicide Attempt Module (HASS-SA)

    Time frame: 30 days (T3), 3 months (T4), and 6 months (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 HASS-SA, the 2 questions that inquire about suicide attempts.

Secondary outcomes

  1. DASS-Y Depression Subscale

    Time frame: 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

    The DASS-Y Depression Subscale is a 7-item sub-measure of the 21-item DASS-Y. 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).

  2. DASS-Y Anxiety Subscale

    Time frame: 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

    The DASS-Y Anxiety Subscale is a 7-item sub-measure of the 21-item DASS-Y. 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).

  3. DASS-Y Stress Subscale

    Time frame: 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

    The DASS-Y Stress Subscale is a 7-item sub-measure of the 21-item DASS-Y. 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).

  4. CHRT-SR-9 Pessimism Subscale

    Time frame: 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

    The CHRT-SR-9 Pessimism Subscale is a 2-item subscale of the CHRT-SR-9. It consists of the items "I feel as if things are never going to get better" and "I have no future," with response options ranging 0-4.

  5. CHRT-SR-9 Helplessness Subscale

    Time frame: 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

    The CHRT-SR-9 Helplessness Subscale is a 2-item subscale of the CHRT-SR-9. It consists of the items "It seems as if I can do nothing right" and "Everything I do turns out wrong," with response options ranging 0-4.

  6. CHRT-SR-9 Despair Subscale

    Time frame: 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

    The CHRT-SR-9 Despair Subscale is a 2-item subscale of the CHRT-SR-9. It consists of the items "I Feel that there is no reason to live" and "I Wish I could just go to sleep and not wake up," with response options ranging 0-4.

  7. CHRT-SR-9 Suicidal Thoughts Subscale

    Time frame: 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

    The CHRT-SR-9 Suicidal Thoughts Subscale is a 3-item subscale of the CHRT-SR-9. It consists of the items "I Have been having thoughts of killing myself," "I Have thoughts about how I might kill myself" and "I Have a plan to kill myself," with response options ranging 0-4.

  8. Disposition change

    Time frame: Hospital discharge/approximately 72 hours after admission (T2)

    This is a dichotomous variable defined as discharge to home instead of inpatient psychiatric care and will be gathered from electronic medical records.

Other outcomes

  1. Change in Efficacy to Cope with Suicidal Thoughts and Urges Scale (Primary Target Mechanism)

    Time frame: Baseline/hospital admission (T1), hospital discharge/approximately 72 hours after admission (T2), and 30 days (T3), 3 months (T4), and 6 months (T5) postdischarge

    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.

  2. Change in Cunningham Treatment Engagement Readiness to Change Subscale (Secondary Target Mechanism)

    Time frame: Baseline/hospital admission (T1), hospital discharge/approximately 72 hours after admission (T2), and 30 days (T3), 3 months (T4), and 6 months (T5) postdischarge

    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".

  3. Change in My Thoughts About Therapy (MTT; REACH Framework Expectancy Scale) (Secondary Target Mechanism)

    Time frame: Baseline/hospital admission (T1), hospital discharge/approximately 72 hours after admission (T2), and 30 days (T3), 3 months (T4), and 6 months (T5) postdischarge

    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".

  4. Change in The Children's Hope Scale (Secondary Target Mechanism)

    Time frame: Baseline/hospital admission (T1), hospital discharge/approximately 72 hours after admission (T2), and 30 days (T3), 3 months (T4), and 6 months (T5) postdischarge

    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.

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Collaborators

  • Children's Hospital of Philadelphia
  • Dartmouth College
  • National Institute of Mental Health (NIMH)
  • University of Vermont

Registry information

Official study title

I-CARE: The Effectiveness of a Modular Digital Intervention to Reduce Suicidal Ideation and Emotional Distress During Pediatric Psychiatric Boarding

Acronym: I-CARE

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 31, 2024
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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