Clinical trial NCT06136260: The Grief Navigation Trial: A Comparison of Two Interventions to Support Parents After Their Child's Unexpected or Traumatic Death
Official title: The Grief Navigation Trial: A Multi-Site Pragmatic Comparative Effectiveness Trial of Interventions to Support Parents After Their Child's Unexpected or Traumatic Death
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bereavement
Keywords: grief
caregivers
community resources
pediatric
self-efficacy
coroners and medical examiners
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor class: OTHER
Collaborators: name: University of Chicago
name: Patient-Centered Outcomes Research Institute
name: Missing Pieces, a program of the HAP Foundation
First posted: 2023-11-18
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Parents of children who die traumatically or unexpectedly from things like suicide or an overdose suffer from mental and physical health problems and can experience massive disruptions in their family life. For about half of these parents, the first, and sometimes only, interactions they have with the healthcare system when their child dies are with a medical examiner or coroner (hereafter 'ME'). But MEs have little to no training in helping grieving families, and there are no standards guiding medical examiners or coroners on how or even if they should help grieving families. This gap leaves parents to find the help they need on their own. This research will test two different strategies for addressing this gap in the healthcare system.

Detailed description: Of approximately 60,000 annual deaths of people \< 25 years old, \~45% occur unexpectedly or traumatically (e.g., from homicide, suicide, or unintentional injury) and become a medical examiner or coroner (hereafter 'ME') case. Parents and caregivers (hereafter 'parents') of these children suffer debilitating mental health issues like complicated grief and depression, physical problems and family dysfunction, and struggle to find support. Often, the ME is parents' sole point of contact with the healthcare system. Yet MEs have limited education, guidance, and tools to support bereaved parents. Scalable systems-level interventions are needed, at the point of ME care, to connect bereaved parents to critical supports.

This study will compare two interventions to facilitate care across healthcare settings for bereaved parents:

1. CommunityRx-Bereavement (CRx-B), an evidence- and theory-based, low intensity, highly scalable intervention, and
2. General bereavement support information (GBSI), a standardized treatment regimen developed from extant literature and current recommended standards for supporting parents after a child's death.

This is a pragmatic, multi-site 1:1 randomized controlled comparative effectiveness study using a type I hybrid design. CRx-B and GBSI will be carried out by Missing Pieces, a community-based organization. To learn about which strategy works better, the study team will ask parents to complete surveys \~6.5 months after their child dies.

Eligibility criteria: Inclusion Criteria:

* Parents or caregivers of ME cases involving a person \< 25 years old from one of the following offices: Cook County Medical Examiners, Lake County Coroners, DuPage County Coroner, Will County Coroner, McHenry County Coroner, Kane County Coroner, Peoria County Coroner
* Parents or caregivers who provide permission to the ME to be referred to Missing Pieces
* Parent or caregivers who are referred to Missing Pieces by a ME
* Parents or caregivers able to read and communicate in English or Spanish

Exclusion Criteria:

* Parents or caregivers unable to read or communicate in English or Spanish
* Parents or caregivers under the age of 18 years old

Primary outcomes:
measure: Parent Self-efficacy for Finding Resources
timeFrame: ~6.5 months after child's death
measure: Complicated Grief
timeFrame: ~6.5 months after child's death
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Cook County Medical Examiner's Office
state: Illinois
city: Joliet
country: United States
facility: Will County Coroner's Office
state: Illinois
city: Peoria
country: United States
facility: Peoria County Coroner's Office
state: Illinois
city: Saint Charles
country: United States
facility: Kane County Coroner's Office
state: Illinois
city: Waukegan
country: United States
facility: Lake County Coroner's Office
state: Illinois
city: Wheaton
country: United States
facility: DuPage County Coroner's Office
state: Illinois
city: Woodstock
country: United States
facility: McHenry County Coroner's Office
state: Illinois
Study officials:
affiliation: Lurie Children's Hospital
name: Kelly Michelson, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chicago
name: Stacy Lindau, MD, MAPP
role: PRINCIPAL_INVESTIGATOR
References: