An interventional study of Education Intervention in Cardiac Arrest, Anxiety Depression and Family Support, sponsored by Children's Hospital of Philadelphia. Recruiting at 1 site in United States. Open to participants aged 0 Days to 17 Years. Per ClinicalTrials.gov, last updated 2026-07-16.
Sponsored by Children's Hospital of Philadelphia · Not applicable, Interventional, and Other
This pilot randomized controlled trial (RCT) will test the feasibility and acceptability of the informational intervention program, Heartsight, to reduce caregivers' uncertainty experienced throughout their child's illness trajectory after cardiac arrest. The investigator aims to enroll up to 30 caregivers of pediatric cardiac arrest patients to (Aim 1a) pilot recruitment and randomization (2:1) procedures, and (Aim 1b) estimate retention rate at 3 months and assess engagement and utilization metrics for frequency of access and time spent on each module of the informational packages. The investigator also aims to evaluate the association of the intervention with efficacy outcomes in an exploratory manner in preparation for a larger trial, including (Aim2a) a preliminary estimate of the association of intervention with the surrogate's uncertainty levels at 3 months post-discharge, and (Aim 2b) a preliminary estimate of the association of intervention with the surrogate's anxiety, depression, and post-traumatic stress symptoms at 3 months post-discharge.
966 studies on the registry are indexed under Heart Arrest; 227 are open to participants now.
This study's planned enrollment of 30 is below the median of 100 across 557 interventional studies indexed under Heart Arrest.
Browse Heart Arrest studies →Children's Hospital of Philadelphia is the lead sponsor of 480 studies on the registry; 85 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 22 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Caregiver
Child
Exclusion Criteria:
1) Parent or legal guardian is not the child's caregiver
Caregivers will receive cardiac arrest education intervention called Heartsight
Other: Education Intervention
Patients and caregivers will receive usual care
Caregivers will receive education modules at multiple time points during their children's post cardiac arrest recovery trajectory
Retention Rate
Proportion of enrolled caregivers who complete the study requirements
Time frame: 3 months post enrollment
Depression Screen as Measured by the Patient Health Questionnaire-4
The Patient Health Questionnaire-4 (PHQ-4) is used to quickly assess and measure symptoms of anxiety. Possible scores range from 0 to 6, where a score of 3 or greater is considered a positive screen.
Time frame: Data is collected at study enrollment in the ICU (baseline), at hospital discharge (approximately 21 days after baseline), and 3 months post-hospital discharge. The data at 3 months post-hospital discharge will be reported.
Anxiety Screen as Measured by the Patient Health Questionnaire-4
The Patient Health Questionnaire-4 (PHQ-4) is used to quickly assess and measure symptoms of anxiety. Possible scores range from 0 to 6, where a score of 3 or greater is considered a positive screen.
Time frame: Data is collected at study enrollment in the ICU (baseline), at hospital discharge (approximately 21 days after baseline), and 3 months post-hospital discharge. The data at 3 months post-hospital discharge will be reported.
Presence and Severity of Post Traumatic Stress Disorder Symptoms as Measured by the Posttraumatic Stress Disorder Checklist (PCL-5)
The Post Traumatic Stress Disorder Checklist (PCL-5) is used to assess the presence and severity of post traumatic stress disorder symptoms. Possible scores range from 0 to 80, with higher scores indicating greater symptom severity.
Time frame: Data is collected at study enrollment in the ICU (baseline), at hospital discharge (approximately 21 days after baseline), and 3 months post-hospital discharge. The data at 3 months post-hospital discharge will be reported.
Uncertainty regarding a child's medical diagnosis, treatment, or health condition as measured by Parents' Perception of Uncertainty Scale (PPUS)
The Parents' Perception Uncertainty in Illness Scale (PPUS) is used to measure a parent's uncertainty surrounding their child's medical diagnosis, treatment, or health condition. Possible scores range from 32 to 160, with higher scores indicating a higher level of uncertainty.
Time frame: Data is collected at study enrollment in the ICU (baseline), at hospital discharge (approximately 21 days after baseline), and 3 months post-hospital discharge. The data at 3 months post-hospital discharge will be reported.
Plan to share: No
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Children's Hospital of Philadelphia