I-CARE Program for Mental Health Disorders

(I-CARE Trial)

Recruiting at 1 trial location

Overseen By Stephanie C. Acquilano, MA

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Dartmouth-Hitchcock Medical Center

Disqualifiers: Psychosis, Eating disorders, Cognitive delays, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 31

Duration: Approximately 72 hours

109 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called I-CARE (Improving Care, Accelerating Recovery & Education), designed to assist children in the hospital awaiting mental health treatment. It aims to determine if a series of videos with workbook activities can reduce emotional distress and suicidal thoughts. The trial will also evaluate whether patients and hospital staff find the program helpful. Children who have visited the emergency department for suicidal thoughts or attempts and speak English are suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to contribute to innovative mental health solutions for young patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the I-CARE program is safe for children?

Research has shown that the I-CARE program is safe and easy to use. In past studies, both young patients and healthcare staff found I-CARE practical and well-received, indicating that people generally like the program and can use it without issues.

No major reports of negative side effects have emerged. The program mainly involves watching videos and completing workbook activities, which are low-risk and easy to manage. Since I-CARE does not involve medication or physical procedures, the chance of negative reactions is very low.

Overall, the program is designed to teach useful skills safely. For those considering joining a clinical trial for I-CARE, it appears to be a comfortable and secure choice. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the I-CARE program because it introduces a fresh approach to supporting adolescents with mental health disorders during boarding. Unlike the usual care, which focuses on basic safety supervision, I-CARE delivers evidence-based psychosocial skills through an engaging format of web-based animated videos and workbook exercises. This method is facilitated by trained professionals who offer personalized attention, potentially accelerating recovery and improving mental health outcomes. The innovative use of digital content combined with one-on-one supervision makes it a standout among existing treatments, which typically do not integrate such interactive educational components.

What evidence suggests that the I-CARE program is effective for mental health disorders?

Research has shown that the I-CARE program, available to participants in this trial, helps reduce emotional distress in teenagers awaiting mental health treatment in hospitals. Studies indicate that after joining I-CARE, teens felt less stressed and more prepared to begin mental health care. This online program teaches essential social and emotional skills through videos and workbook exercises. Participants found it practical and helpful, suggesting it could be beneficial in similar situations. Overall, early findings suggest I-CARE can positively impact mental health and prepare teenagers for further treatment. ^{1 2 4 6 7}

Who Is on the Research Team?

JoAnna K Leyenaar, MD, PhD, MPH

Principal Investigator

Dartmouth Health

Are You a Good Fit for This Trial?

This trial is for English-speaking children aged 12-17 who are in a medical hospital due to suicidal thoughts or attempts, waiting for mental health treatment. They must be supervised by a safety attendant and can start the day after they're medically cleared.

Inclusion Criteria

Experiencing psychiatric boarding while awaiting transfer for inpatient psychiatric care

I am eligible the day after being admitted or cleared by a hospital.

Supervised one-on-one by a safety attendant

Exclusion Criteria

Admission or transfer for psychiatric care anticipated on the first day of potential enrollment

Cognitive or developmental delays that preclude program participation based on clinical team assessment

Clinical team concern for patient or staff safety based upon active behavioral concerns

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants engage with the I-CARE program, completing as many of the 7 videos and workbook activities as possible during their hospital stay.

Approximately 72 hours

Continuous engagement during hospital stay

Follow-up

Participants are monitored for changes in emotional distress and suicidal ideation post-discharge.

6 months

Follow-up assessments at 30 days, 3 months, and 6 months post-discharge

What Are the Treatments Tested in This Trial?

Interventions

• Improving Care, Accelerating Recovery & Education (ICARE)

Trial Overview The I-CARE program, which includes videos and workbook activities aimed at reducing emotional distress and suicide risk among hospitalized youth awaiting psychiatric care, is being tested for its effectiveness and acceptability.

How Is the Trial Designed?

Group I: I-CARE Experimental Treatment 1 Intervention

I-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.

Group II: Usual Care Active Control 1 Intervention

These hospitals currently offer basic safety supervision and medical monitoring for adolescents during mental health boarding. This is the "usual care" condition.

Improving Care, Accelerating Recovery & Education (ICARE) is already approved in United States for the following indications:

Approved in United States as I-CARE for:

• Mental health treatment for children awaiting inpatient care

Who Is Running the Clinical Trial?

Dartmouth-Hitchcock Medical Center

Lead Sponsor

Trials

548

Recruited

2,545,000+

University of Vermont

Collaborator

Trials

283

Recruited

3,747,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Dartmouth College

Collaborator

Trials

93

Recruited

1,415,000+

Children's Hospital of Philadelphia

Collaborator

Trials

749

Recruited

11,400,000+

University of Vermont Medical Center

Collaborator

Trials

46

Recruited

25,900+

Published Research Related to This Trial

After one year of training, 35 New Zealand practitioners found it challenging to fully implement Integrated Mental Health Care (IMHC) due to resource constraints, despite its potential for cost-effectiveness compared to traditional hospital care.

Practitioners appreciated the structured approach and psychosocial focus of IMHC, which positively influenced their views on severe mental health issues, but they suggested adaptations to better fit local needs and enhance flexibility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated mental health care: practitioners' perspectives. Allen, RE., Read, J.[2017]

A quality improvement project involving 124 psychiatric patients showed that individualized safety plans created during inpatient treatment were well-tailored, scoring an average of 32.85 out of 44 on a customization rubric.

Postdischarge, 96.1% of patients retained their safety plans, and 36.8% reported using them, with 67.9% of those users finding the plans helpful, indicating that these plans can support recovery after hospitalization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bridging the Gap Between Individualized Inpatient Safety Planning and Postdischarge Efficacy. Leonard, J., Chiappetta, L., Stark, S., et al.[2023]

The RECOVER model for mental health care is being tested against standard care (TAU) in a study involving 890 patients, focusing on its effectiveness in reducing healthcare costs and improving patient outcomes over 6 and 12 months.

The study will measure key outcomes such as symptom improvement, daily functioning, and quality of life, using rigorous statistical methods to ensure unbiased results, which could demonstrate the cost-effectiveness of the RECOVER model.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol for a randomised controlled trial evaluating an evidence-based, stepped and coordinated care service model for mental disorders (RECOVER). Lambert, M., Karow, A., Gallinat, J., et al.[2023]

The adapted Illness Management and Recovery (IMR) program significantly improved illness-management knowledge, attitudes toward medication, insight, and negative symptoms in 97 individuals with schizophrenia compared to treatment as usual (TAU) during a randomized controlled trial in Taiwan.

This study is the first to evaluate the IMR program in an acute inpatient setting in East Asia, demonstrating its feasibility and potential benefits for preparing individuals for community reintegration after hospitalization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of an adapted Illness Management and Recovery program for people with schizophrenia awaiting discharge from a psychiatric hospital. Lin, EC., Chan, CH., Shao, WC., et al.[2019]

The ICare program aims to evaluate the cost-effectiveness of internet-based interventions for mental health, addressing the gap in access to traditional treatments, with a focus on data from clinical trials across seven countries.

This study will provide valuable insights into the economic benefits of these interventions by analyzing service use and costs, ultimately helping to determine their relative cost-effectiveness compared to standard treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the costs and cost-effectiveness of ICare internet-based interventions (protocol). Beecham, J., Bonin, EM., Görlich, D., et al.[2022]

The study involved 146 patients admitted to a 20-bed Intermediate Stay Mental Health Unit (ISMHU) in Australia, where a 6-week recovery-oriented intervention program led to significant improvements in social connection, symptoms, and self-belief.

Patients referred from the community showed the most substantial reduction in future acute mental health admissions, dropping from 58.3% to 16.7%, highlighting the effectiveness of tailored care pathways in improving long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Care pathways, engagement and outcomes associated with a recovery-oriented intermediate stay mental health program. Sly, KA., Lewin, TJ., Frost, BG., et al.[2020]

The Illness Management and Recovery (IMR) program, designed for individuals with schizophrenia and severe mental illnesses, showed promising results in a pilot study with 24 participants, indicating high satisfaction and significant improvements in coping with symptoms and overall functioning over a 9-month period.

Participants reported moderate gains in knowledge about mental illness, reduced distress, increased hope, and better goal orientation, suggesting that the IMR program may be effective, but further controlled studies are needed to validate these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Illness Management and Recovery program: rationale, development, and preliminary findings. Mueser, KT., Meyer, PS., Penn, DL., et al.[2018]

Participants with serious mental illnesses reported high levels of perceived helpfulness from the Illness Management and Recovery (IMR) program one year after completion, indicating its lasting positive impact.

The IMR program was found to improve cognition, coping, and social support, and was perceived as unique compared to other rehabilitation interventions due to its focus on learning, structured support, and a message of hope.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A one year follow-up of illness management and recovery: participants' accounts of its impact and uniqueness. Roe, D., Hasson-Ohayon, I., Salyers, MP., et al.[2019]

Individuals with serious mental illness have a significantly shorter lifespan, dying 10-20 years earlier than the general population, primarily due to untreated physical health issues.

Experts recommend integrating physical health care into mental health programs, emphasizing the need for research on effective care models, new financing strategies, and addressing socioeconomic factors that contribute to this excess mortality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Physical Health Among People With Serious Mental Illness: The Role of the Specialty Mental Health Sector. McGinty, EE., Presskreischer, R., Breslau, J., et al.[2022]

In a study of 120 veterans with serious mental disorders, those receiving integrated primary care in a mental health clinic had significantly more primary care visits and received more preventive care compared to those in a general medicine clinic.

Patients in the integrated care clinic showed a notable improvement in physical health, as indicated by a 4.7-point increase in their health survey scores, while there were no significant changes in mental health symptoms or overall healthcare costs between the two groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated medical care for patients with serious psychiatric illness: a randomized trial. Druss, BG., Rohrbaugh, RM., Levinson, CM., et al.[2022]

The 'ICare' network aims to create a comprehensive model for delivering eMental health services across Europe, addressing the need for effective online interventions to prevent mental health issues.

A stakeholder survey was conducted to gather insights on experiences and attitudes towards online mental health prevention, using a mixed methods approach to ensure diverse perspectives from target groups, delivery staff, and policymakers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stakeholder consultation to facilitate implementation of interventions for prevention and promotion in mental health in Europe: introducing the design of the ICare Stakeholder Survey. Nitsch, M., Waldherr, K., Zeiler, M., et al.[2021]

Internet-based treatments for common mental health disorders like depression, anxiety, substance abuse, and eating disorders have been shown to effectively reduce symptoms, according to systematic reviews and meta-analyses.

While these online interventions are generally effective, they tend to have lower effect sizes for eating disorders and substance abuse compared to those for depression and anxiety, indicating varying levels of efficacy across different conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current state of scientific evidence on Internet-based interventions for the treatment of depression, anxiety, eating disorders and substance abuse: an overview of systematic reviews and meta-analyses. Taylor, CB., Graham, AK., Flatt, RE., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07150832

Efficacy of the I-CARE Digital Health Intervention 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 ...

2. jahonline.org jahonline.org/article/S1054-139X(23)00062-9/fulltext

I-CARE: Feasibility, Acceptability, and Appropriateness of a ... This pilot study describes changes in emotional distress, severity of illness, and readiness for engagement following I-CARE participation.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1054139X23000629

I-CARE: Feasibility, Acceptability, and Appropriateness of a ... I-CARE is a novel digital health intervention designed to teach evidence-based psychosocial skills to youth awaiting transfer for inpatient psychiatric care.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36870901/

I-CARE: Feasibility, Acceptability, and Appropriateness of a ... I-CARE was feasible to implement and youth reported reduced levels of distress following participation. I-CARE has the potential to teach ...

5. jahonline.org jahonline.org/article/S1054-139X(23)00062-9/pdf

I-CARE This pilot study describes changes in emotional distress, illness severity, and readiness to engage in mental healthcare among youth following I-CARE.

6. reporter.nih.gov reporter.nih.gov/search/Hg1SDhR1-EeS4pe2hKBYmw/project-details/10756733

RePORT RePORTER - National Institutes of Health (NIH) | In a pilot program evaluation, I-CARE has been shown to be feasible to implement and acceptable to youth, clinicians, and their caregivers, with levels of ...

7. withpower.com withpower.com/trial/phase-mental-disorders-1-2024-8736f

I-CARE Program for Mental Health Disorders (I-CARE Trial) 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.