Support Sessions for Parents With Children in the Pediatric Intensive Care Unit
1 other identifier
interventional
100
1 country
1
Brief Summary
The goal of this clinical trial is to learn if Grief-informed Parent Support sessions offered weekly to parents with a child in the pediatric intensive care unit work to decrease symptoms of parent grief compared to a non-grief informed parent support program offered weekly to parents with a child in the pediatric intensive care unit. The main question is: Do parents with a child in the pediatric intensive care unit report fewer symptoms of grief, such as depression and anxiety, following their attendance at a parent support program with a grief-informed intervention compared to parents who receive a non-grief informed support program. Participants will be randomized to : Receive a 8-session grief-informed parent support program or a 8-session non grief-informed parent support program. Parents will report symptoms of grief before and after the 8-session parent support program.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2024
CompletedFirst Submitted
Initial submission to the registry
April 2, 2025
CompletedFirst Posted
Study publicly available on registry
April 9, 2025
CompletedApril 10, 2025
April 1, 2025
1.6 years
April 2, 2025
April 9, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
parent grief
number of parent grief symptoms, such as depression and anxiety
12 months
Study Arms (1)
Support Sessions for Parents on Expressing Grief
EXPERIMENTALParents in the experiment group will receive 8 Grief-informed support sessions. Each session is curriculum driven and completed in a group session. each session lasts 1 hour. Each session will be delivered by a trained person in grief and loss.
Interventions
Eight one-hour sessions delivered in a group setting
Eligibility Criteria
You may qualify if:
- \- Parent of a child in the pediatric intensive care unit
You may not qualify if:
- \- Not a parent of a child in the pediatric intensive care unit
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Texas Woman's University
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Judith M McFarlane, DrPH
Texas Woman's University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 2, 2025
First Posted
April 9, 2025
Study Start
December 2, 2022
Primary Completion
June 30, 2024
Study Completion
August 30, 2024
Last Updated
April 10, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- June 2025 - December 2026
- Access Criteria
- From the investigator at jmcfarlane@twu.edu
outcome measure of parent grief and 8-session grief-informed intervention