Clinical trial NCT06919601: Support Sessions for Parents With Children in the Pediatric Intensive Care Unit
Official title: Support Sessions for Parents With Children in the Pediatric Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parent Support
Keywords: parents grief intensive care support
death of child
death, grief, parent, child
Lead sponsor: Texas Woman's University
Sponsor class: OTHER
First posted: 2025-04-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: parent grief
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Woman's University
state: Texas
Study officials:
affiliation: Texas Woman's University
name: Judith M McFarlane, DrPH
role: PRINCIPAL_INVESTIGATOR
References: