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Mental Health DisorderI-CARENCT06233747

Improving Care, Accelerating Recovery and Education

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 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 12 to 17 years
What is being tested?
Improving Care, Accelerating Recovery & Education (ICARE)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
89 participants
Where
2 sitesUnited States
Study dates
29 Feb 2024to 31 Jul 2026
Phase
Interventional
Are there results?
None posted in the registry

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 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • University of Vermont Medical Center

    Burlington, Vermont, 05401

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official 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.

Read the detailed description

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.

Being tested
Improving Care, Accelerating Recovery & Education (ICARE)
Keywords
children, adolescents, emergency department, psychosocial skills, mental health boarding
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 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.

Study groups in NCT06233747
Study groupRoleWhat they receive
I-CAREExperimentalI-CARE (Improving Care, Accelerating Recovery \& Education) is a quality improvement 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 licensed nursing assistants/behavioral health technicians/safety attendants who provide one-on-one safety supervision during boarding. I-CARE will be offered to all eligible adolescents who are boarding and only those who agree to participate in a program evaluation will be involved in the research component.
Receives: Behavioral: Improving Care, Accelerating Recovery & Education (ICARE)
Usual CareNo interventionThese 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.

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

    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), 3 months (T4), and 6 months (T5) post-discharge

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

    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.

    Measured: 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)

    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.

    Measured: 30 days (T3), 3 months (T4), and 6 months (T5) postdischarge

Secondary outcomes (8)
  1. DASS-Y Depression Subscale

    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).

    Measured: 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. DASS-Y Anxiety Subscale

    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).

    Measured: 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

  3. DASS-Y Stress Subscale

    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).

    Measured: 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

  4. CHRT-SR-9 Pessimism Subscale

    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.

    Measured: 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

  5. CHRT-SR-9 Helplessness Subscale

    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.

    Measured: 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

  6. CHRT-SR-9 Despair Subscale

    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.

    Measured: 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

  7. CHRT-SR-9 Suicidal Thoughts Subscale

    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.

    Measured: 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

  8. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2024
  2. Study start29 Feb 2024
  3. Primary completion25 Jul 2026
  4. Study completion31 Jul 2026

Resources

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
Model description
This is a stepped wedge pilot study, in which 2 hospitals will be randomized to begin implementation of I-CARE at 2 different times within the 17-month study period. Both sites begin with an initial 3-month period of treatment-as-usual and the research team collects all outcome measures during this period, then 1 hospital will crossover to launch the I-CARE intervention and the other will launch 2 months later (continuing to provide treatment-as-usual in the interim). This may be considered a form of a parallel cluster study, in which one of the two hospitals is initially randomized to I-CARE while the other remains in the baseline/treatment-as-usual state.
Masking
None (open label)
Enrolment
89 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06233747
Sponsor's protocol ID
STUDY02002045
Other IDs
RF1MH134626
Acronym
I-CARE
Status last verified
Sep 2026
First submitted
12 Jan 2024
Last updated
2 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 109 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. Efficacy to Cope with Suicidal Thoughts and Urges Scale 5. The Children's Hope Scale 6. My Thoughts about Therapy Expectancy Scale 7. Cunningham Treatment Engagement Readiness to Change Scale 8. DSM-5 Self-Rated Level 1 Cross-Cutting Symptom Measure for Youth 9. RCADS-25 for Youth

Questions about this trial

What is this clinical trial studying?

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 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.

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