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

Overview

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.

Interventions

• Other CommunityRx-Bereavement
  The medical examiner or coroner will refer parents to an organization called Missing Pieces. Missing Pieces does not deliver healthcare services to grieving families; rather, Missing Pieces helps families find grief services in their community. For CRx-B, a Grief Navigator from Missing Pieces will text and/or call the parent after receiving the referral; share information about grief and support resources; learn what resources the parent needs for themselves and their family; send the parent a
• Other General Bereavement Support Information
  The medical examiner or coroner will refer parents to an organization called Missing Pieces. Missing Pieces does not deliver healthcare services to grieving families; rather, Missing Pieces helps families find grief services in their community. For GBSI, Missing Pieces sends parents a unidirectional text message providing a link to a webpage with a general list of grief resources (e.g., support groups) and information about grief and bereavement within two weeks of the child's death and again 3

Primary outcome measures

• Parent Self-efficacy for Finding Resources [Time frame: ~6.5 months after child's death]
• Complicated Grief [Time frame: ~6.5 months after child's death]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Health services research

Study locations

United States · 7 centers

• Cook County Medical Examiner's Office — Chicago
• Will County Coroner's Office — Joliet
• Peoria County Coroner's Office — Peoria
• Kane County Coroner's Office — Saint Charles
• Lake County Coroner's Office — Waukegan
• DuPage County Coroner's Office — Wheaton
• McHenry County Coroner's Office — Woodstock

Publications

• Agha E, Sutter C, Ojewuyi I, Abramsohn EM, Andriano M, Bell C, Calix AL, Cherry JL, Downing K, Flower T, Halm M, Hayes A, Heffernan ME, Hill J, Hoeppner CZ, Jacobson M, Jennings J, Kula-Leitner L, Lee S, Major DR, Makelarski JA, Maruyama NL, McNicholas A, Newton S, Shuber C, Vesco AT, Lindau ST, Michelson KN; Grief Navigation Trial Study Team. The Grief Navigation Trial: A multi-site pragmatic com PMID 40436312

Identifiers

NCT: NCT06136260 · 2023-6458

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗