Improving Care, Accelerating Recovery and Education

NCT06233747 | Active Not Recruiting DMC

• 2 other identifiers: STUDY02002045RF1MH134626
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Mental Health Disorder; Emergency Psychiatric; Suicide Attempt; Suicidal Ideation

Keywords

children; adolescents; emergency department; psychosocial skills; mental health boarding

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (5)

• Change in Efficacy to Cope with Suicidal Thoughts and Urges Scale

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

• Change in The Children's Hope Scale

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

• Change in My Thoughts About Therapy (MTT; REACH Framework Expectancy Scale)

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

• Change in Cunningham Treatment Engagement Readiness to Change Subscale

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

• Disposition change

  Hospital discharge/approximately 72 hours after admission (T2)

Study Arms (2)

I-CARE

EXPERIMENTAL

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.

Behavioral: Improving Care, Accelerating Recovery & Education (ICARE)

Usual Care

NO INTERVENTION

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

Interventions

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.

I-CARE

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dartmouth College: collaborator
• Children's Hospital of Philadelphia: collaborator
• University of Vermont: collaborator
• Dartmouth-Hitchcock Medical Center: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

Location

MeSH Terms

Conditions

Mental Disorders; Suicide, Attempted; Suicidal Ideation; Emergencies

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• JoAnna K Leyenaar, MD, PhD, MPH

  Dartmouth Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator; Staff Physician; Professor of Pediatrics

Model Details: 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.

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: January 31, 2024
• Study Start: February 29, 2024
• Primary Completion (Estimated): July 25, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: All data will be deposited to NDA starting 12 months after the award begins and will be deposited every six months thereafter following the usual NDA data submission dates.
• Access Criteria: All those with access to the NDA will have access to our data.

Locations

US (2)