Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07707037

Removing Surrogates Uncertainty to Reduce Fear and Anxiety After Cardiac Events - Kids

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Cardiac Arrest Anxiety Depression Cardiovascular Diseases Family Support Heart Arrest Heart Diseases

Age range

0 day–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location status: Recruiting

Location contact

Elizabeth Herrup, MD

CONTACT

[email protected]

215-514-0166

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Caregiver

  • Caregiver of a child <17.5 years of age who had at least a 2 minute cardiac arrest, is expected to be discharged within 30 days, and to survive at least 3 months post-discharge from hospital.
  • English speaking

Child

  • <17.5 years of age
  • Have had a cardiac arrest lasting more than 2 minutes within the past 7 days and have not yet been discharged from pediatric intensive care unit (PICU) or cardiac intensive care unit (CICU)

Exclusion criteria

  • Parent or legal guardian is not the child's caregiver

Treatment and study plan

Education Intervention

Other

Caregivers will receive education modules at multiple time points during their children's post cardiac arrest recovery trajectory

Primary outcomes

  1. Retention Rate

    Time frame: 3 months post enrollment

    Proportion of enrolled caregivers who complete the study requirements

Secondary outcomes

  1. Depression Screen as Measured by the Patient Health Questionnaire-4

    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.

    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.

  2. Anxiety Screen as Measured by the Patient Health Questionnaire-4

    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.

    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.

  3. Presence and Severity of Post Traumatic Stress Disorder Symptoms as Measured by the Posttraumatic Stress Disorder Checklist (PCL-5)

    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.

    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.

  4. Uncertainty regarding a child's medical diagnosis, treatment, or health condition as measured by Parents' Perception of Uncertainty Scale (PPUS)

    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.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Elizabeth Herrup, MD

CONTACT

[email protected]

215-514-0166

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Registry information

Acronym: RESURFACE-Kids

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 16, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.