The Missing Pieces Trial: A Comparison of Two Interventions to Support Parents After Their Child's Unexpected or Traumatic Death

A

Ann & Robert H Lurie Children's Hospital of Chicago

Status

Enrolling

Conditions

Bereavement

Treatments

Other: CommunityRx-Bereavement
Other: General Bereavement Support Information

Study type

Interventional

Funder types

Other

Identifiers

NCT06136260
2023-6458

Details and patient eligibility

About

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.

Full 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: CommunityRx-Bereavement (CRx-B), an evidence- and theory-based, low intensity, highly scalable intervention, and 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.

Enrollment

2,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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
  • 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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

2,000 participants in 2 patient groups

CommunityRx-Bereavement (CRx-B)
Experimental group
Treatment:
Other: CommunityRx-Bereavement
General Bereavement Support Information (GBSI)
Active Comparator group
Treatment:
Other: General Bereavement Support Information

Trial contacts and locations

0

Loading...

Central trial contact

Carolyn Sutter, PhD; Kelly Michelson, MD, MPH

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems