Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT06136260 |
Other study ID # |
2023-6458 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
March 4, 2024 |
Est. completion date |
February 2028 |
Study information
Verified date |
March 2024 |
Source |
Ann & Robert H Lurie Children's Hospital of Chicago |
Contact |
Kelly Michelson, MD, MPH |
Phone |
312-227-4800 |
Email |
kmichelson[@]luriechildrens.org |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.