Support Sessions for Parents With Children in the Pediatric Intensive Care Unit

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.

Study Overview

• Status: Completed
• Conditions: Parent Support
• Intervention / Treatment: Behavioral: Grief-Informed Healing Circles

Detailed Description

Grief is the response to a loss. Infants and children in intensive care units are at increased risk for chronic morbidity and death. Grief is a normal response to the potential or actual loss of a child. Grief related disorders of Post-Traumatic Stress Disorder (PTSD), anxiety, depression, and insomnia are reported by parents of children in PICU's.

To test the efficacy and impact of a grief-informed intervention, 100 parents of infants and children admitted to a PICU were recruited, within the first 7 days of admission. Fifty parents were randomized to 8, 1-hour grief informed sessions, led by a trained facilitator that followed a curriculum of validating grief and inviting each parent to share their grief.

Fifty parents were randomized to 8, 1-hr attention control sessions, led by a registered nurse, who offered guided imagery, meditation, and chair-based exercises. Attendance at sessions was recorded to establish dose and intervention efficacy. Following the 8 sessions, parents were administered the Parent Experiences Questionnaire (PEQ) to measure the 4 domains of: Unresolved Sorrow and Anger, Guilt and Worry, Long-Term Uncertainty, and Emotional Resources. Sixty-Four (64) parents completed the PEQ measure. Thirty-eight (38) of the 63 parents joined a second study to measure the PEQ four domains and parent and sibling behavioral functioning every 3 months for 12 months. A final qualitative interview will be offered to each parent completing the study (estimated 30 parents) and qualitative data triangulated with PEQ scores.

Attendance at the grief informed, Healing Circles Intervention, sessions was TWICE that of the attention control sessions. The differential scores of the four domains of the Parent Experiences Questionnaire were measured at 2 weeks after last session and at 3-, 6-, 9-, and 12 months. The PEQ four domain and total scores were correlated to Parent and Sibling functioning, as measured on the Adult and Child Behavior Checklist, respectively. Behavior functioning scores were scored as pre-clinical/clinical behaviors and non-clinical behaviors. All data was modeled to learn predictive patterns to best inform clinical practices for siblings and parents of children in the Pediatric Intensive Care Unit (PICU).

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Texas Woman's University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

- Parent of a child in the pediatric intensive care unit

Exclusion Criteria:

- Not a parent of a child in the pediatric intensive care unit

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Support Sessions for Parents on Expressing Grief; 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; Eight one-hour sessions delivered in a group setting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
parent grief	number of parent grief symptoms, such as depression and anxiety	12 months

Collaborators and Investigators

• Sponsor: Texas Woman's University
• Investigators: Principal Investigator: Judith M McFarlane, DrPH, Texas Woman's University

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2022
• Primary Completion (Actual): June 30, 2024
• Study Completion (Actual): August 30, 2024

Study Registration Dates

• First Submitted: April 2, 2025
• First Submitted That Met QC Criteria: April 2, 2025
• First Posted (Actual): April 9, 2025

Study Record Updates

• Last Update Posted (Actual): April 10, 2025
• Last Update Submitted That Met QC Criteria: April 9, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: parents grief intensive care support; death of child; death, grief, parent, child
• Other Study ID Numbers: IRB-FY2022-338

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: outcome measure of parent grief and 8-session grief-informed intervention
• IPD Sharing Time Frame: June 2025 - December 2026
• IPD Sharing Access Criteria: From the investigator at jmcfarlane@twu.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No