NCT06919601

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 9, 2025

Completed
Last Updated

April 10, 2025

Status Verified

April 1, 2025

Enrollment Period

1.6 years

First QC Date

April 2, 2025

Last Update Submit

April 9, 2025

Conditions

Keywords

parents grief intensive care supportdeath of childdeath, grief, parent, child

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

EXPERIMENTAL

Parents 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.

Behavioral: Grief-Informed Healing Circles

Interventions

Eight one-hour sessions delivered in a group setting

Support Sessions for Parents on Expressing Grief

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Death

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Judith M McFarlane, DrPH

    Texas Woman's University

    PRINCIPAL INVESTIGATOR

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

outcome measure of parent grief and 8-session grief-informed intervention

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
June 2025 - December 2026
Access Criteria
From the investigator at jmcfarlane@twu.edu

Locations