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NCT06117345

Enhancing Parent/Caregiver Engagement in the Pediatric Intensive Care Unit (PICU): A PICU Journal

Enrolling by Invitation
NAAges 18+InterventionalSupportive care
Vanderbilt University Medical Center
~75 participants
Updated 2026-06-09 on ClinicalTrials.gov
What's tested:PICU Journal

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Parent/Caregiver reported stress level
Measured over At study enrollment (T1), within 48 hours of child's discharge from hospital (T2)
+7 more outcomes measured

Conditions

Critical Illness

Explore related trials

Critical Illness

Where it's being run

1 sites across 1 states
Tennessee1

Study leadership

  • Kristina Betters, MD · PRINCIPAL_INVESTIGATOR · Vanderbilt University Medical Center

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

The participant is a primary caregiver of a pediatric patient (ages 1 month to 21 years) admitted to the pediatric intensive care unit (PICU) at Monroe Carell Jr. Children's Hospital at Vanderbilt (MCJCHV)
The participant's child meets the criteria for Levels 1 or 2 of the Early Mobility Protocol at MCJCHV
The participant's child has been hospitalized in the PICU for between 24 and 72 hours at the time of informed consent.
The participant has not had prior experience with their child(ren) being admitted to the PICU.
The participant is proficient in reading and writing the English language.
The child participant is between the ages of 8 to 17 years.
The participant is proficient in reading and writing the English language.
The participant(s) interact with patients in the PICU at Monroe Carell Jr. Children's Hospital at Vanderbilt.
The participant is proficient in reading and writing the English language.

Exclusion

The participant is unwilling to provide consent.
The participant is unable to read and write in the English language.
The participant is unwilling to provide assent.
The participant is unable to read and write in the English language.

What this trial measures

  • Parent/Caregiver reported stress levelAt study enrollment (T1), within 48 hours of child's discharge from hospital (T2)

    Score on the Abbreviated Parental Stressor Scale: Pediatric Intensive Care Unit; 7 Likert type items scored from 1 to 5, with 1 being "not stressful" and 5 being "extremely stressful." Composite scores can range from 0 (not experienced) to 35 (extremely stressful).

  • Parent/Caregiver care engagement levelAt study enrollment (T1), within 48 hours of child's discharge from hospital (T2)

    Score on the Caregiving Health Engagement Scale; 7 items with four answer choices scored from 1 to 4. Composite scores can range from 7 (minimal engagement) to 28 (high engagement).

  • Parent/Caregiver reported depression and anxiety symptomswithin 48 hours of child's discharge from hospital (T2), at 3 months post-discharge (T3)

    Score on the Hospital Anxiety and Depression Scale; two subscales (anxiety and depression) with 7 items each. Items have 4 answer choices scored from 1 to 4, with higher numbers indicating higher alignment with anxiety or depression. Cut scores are used to determine clinical significance; a total score of less than 7 on a subscale indicates a non-case, 8-10 on a subscale indicates mild, 11-14 indicates moderate, and 15 to 21 is considered severe.

  • Parent/caregiver reported impact of eventsat 3 months post-discharge (T3)

    Score on Impact of Events Scale-Revised; 20 Likert-type items scored from 0 (not experienced) to 4 (extremely distressed). Total composite scores can range from 0 (not experienced) to 80 (extremely distressed).

  • Parent/Caregiver use of and satisfaction with PICU journalwithin 48 hours of child's discharge from hospital (T2), at 3 months post-discharge (T3)

    Responses to a descriptive survey created by research team to assess frequency/type of PICU journal use and completion, as well as parent/caregiver perceptions of feasibility and utility

  • Child reported impact of eventsat 3 months post-discharge (T3)

    Score on the Child Revised Impact of Events Scale; 8 items with four answer choices scored from 0 (not at all) to 3 (often). Total composite scores can range from 0 (not at all distressed) t to 24 (extremely distressed).

  • Parent/caregiver Experiences Interviewat 3 months post-discharge (T3)

    Responses to semi-structured interview about PICU journal perceptions and experiences (in-person, by phone, or by teleconference)

  • PICU Staff perceptions of PICU journal interventionThrough study completion, an expected average of 2 years

    Responses to a descriptive survey created by research team to collect perceptions about and level of engagement with PICU journal intervention