Efficacy of the I-CARE Digital Health Intervention
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-17
SponsorDartmouth-Hitchcock Medical Center
About this trial
When presenting to an ED with suicide, self-harm or other mental health crises, youth may also experience "boarding", which is defined by the Joint Commission as "the practice of holding patients in the ED or another temporary location after the decision to admit or transfer has been made." A recent national survey of 88 US acute care hospitals conducted by our research team found that 98.9% of hospitals were boarding youth awaiting psychiatric hospitalization, for an average of 2-3 days. However, as illustrated in a systemic review, little research has focused on developing interventions to support youth during this highly vulnerable time. 3
I-CARE is a modular, blended digital health intervention facilitated by individuals who are not mental health clinical staff to teach youth evidence-based psychosocial skills during the boarding period. This study will evaluate I-CARE's efficacy using a patient-level randomized clinical trial (RCT), randomizing youth to receive standard safety supervision or I-CARE in addition to standard safety supervision. If found to the efficacious, I-CARE could be scaled-up in new settings with limited resources and has the potential to significantly improve the quality of care received by youth experiencing boarding.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adolescents of any sex and gender, aged 12-17 years at ED visit or hospital encounter
Presenting with suicide attempt or ideation, or self-harm
Medically stable
English-speaking
Disqualifiers
Cognitive or developmental delays precluding participation (intellectual functioning <12 years of age)
Behavioral limitations that preclude program participation
Active psychosis
Legal parent/caregiver unable to speak English or unavailable to provide consent (e.g. Wards of the State)
Trial design
Design model
Parallel
Treatments tested in this trial
Improving Care, Accelerating Recovery & Education (ICARE)
BehavioralI-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 individuals who are not mental health professionals. All modules are grounded in evidence-based practices, such as cognitive-behavioral therapy and dialectical behavior therapy.
Treatment groups
173 Participants
are divided into 2 treatment groupsGroup A: I-CAREExperimental treatment 1 intervention
Group B: Safety SupervisionNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Depression Anxiety Stress Scales Youth Version (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).
Time frame
Baseline/hospital admission (T1), hospital discharge/approximately 72 hours after admission (T2), and 30 days (T3), 60 days (T4), and 90 days (T5) post-discharge2
9-item Concise Health Risk Tracking - Self-Report (CHRT-SR9)
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.
Time frame
Baseline/hospital admission (T1), hospital discharge/approximately 72 hours after admission (T2), and 30 days (T3), 60 days (T4), and 90 days (T5) postdischarge3
Harkavy-Asnis Suicide Scale (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.
Time frame
Time Frame: 30 days (T3), 60 days (T4), and 90 days (T5) postdischargeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Dartmouth-Hitchcock Medical Center
Lead sponsor
Trustees of Dartmouth College
Sponsor institution
Yale University
Collaborator
Weill Medical College of Cornell University
Collaborator
Dartmouth College
Collaborator
Source ClinicalTrials.gov