The Grief Navigation Trial: A Comparison of Two Interventions to Support Parents After Their Child's Unexpected or Traumatic Death
1 other identifier
interventional
2,000
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2024
Longer than P75 for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 11, 2023
CompletedFirst Posted
Study publicly available on registry
November 18, 2023
CompletedStudy Start
First participant enrolled
March 4, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2028
May 1, 2025
April 1, 2025
3.3 years
November 11, 2023
April 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Parent Self-efficacy for Finding Resources
Domain-specific item assessing self-efficacy related to support after a child's death, based on Bandura's Self-Efficacy Scale, "How confident are you in your ability to find resources to support you after your child's death?" Responses are on a 5-point Likert scale ranging from "not at all confident" to "completely confident."
~6.5 months after child's death
Complicated Grief
Index of Complicated Grief, 19-item tool that uses a 5-point Likert scale ("never" to "always"). Responses are scored 0 to 4 and totaled (0 to 76) with higher scores indicating more symptoms of grief.
~6.5 months after child's death
Study Arms (2)
CommunityRx-Bereavement (CRx-B)
EXPERIMENTALGeneral Bereavement Support Information (GBSI)
ACTIVE COMPARATORInterventions
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 personalized list of grief and social support community resources called a HealtheRx via text, email, or mail; and plan future text message communications with bidirectional functionality and, if requested, subsequent calls or texts from the Grief Navigator to occur at least 3, 6, and 12 months after the child's death.
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, 6, and 12 months after the child's death.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Parents or caregivers unable to read or communicate in English or Spanish
- Parents or caregivers under the age of 18 years old
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Cook County Medical Examiner's Office
Chicago, Illinois, 60612, United States
Will County Coroner's Office
Joliet, Illinois, 60432, United States
Peoria County Coroner's Office
Peoria, Illinois, 61603, United States
Kane County Coroner's Office
Saint Charles, Illinois, 60175, United States
Lake County Coroner's Office
Waukegan, Illinois, 60085, United States
DuPage County Coroner's Office
Wheaton, Illinois, 60187, United States
McHenry County Coroner's Office
Woodstock, Illinois, 60098, United States
Related Publications (1)
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 comparative effectiveness trial of two interventions to support parents after their child's unexpected or traumatic death. Contemp Clin Trials. 2025 Aug;155:107962. doi: 10.1016/j.cct.2025.107962. Epub 2025 May 26.
PMID: 40436312DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Kelly Michelson, MD, MPH
Lurie Children's Hospital
- PRINCIPAL INVESTIGATOR
Stacy Lindau, MD, MAPP
University of Chicago
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Randomization will occur after a medical examiner or coroner (ME) case is referred to Missing Pieces. Participants and MEs will be blinded to participants' treatment arm; Missing Pieces and study staff will be aware of intervention assignments. Missing Pieces will randomize all referred ME cases, (except cases referred from Lake County where the intervention has already been adopted into practice) to CRx-B or GBSI using the method of permuted blocks and the uniform random number function in Stata V17. To ensure balance of intervention arms by ME office, randomization will be stratified by ME office.
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending Physician
Study Record Dates
First Submitted
November 11, 2023
First Posted
November 18, 2023
Study Start
March 4, 2024
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
February 1, 2028
Last Updated
May 1, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- After the study period for at least 7 years
A full data package with the combined data will be created for the purpose of data sharing. During the study period (including data collection and analysis) access to the data will be restricted to the study team. Any secondary analysis of the dataset during the study period will need to be assessed and approved by the dual PIs, Dr. Michelson and Dr. Lindau with input from the steering committee at their discretion. This data package will be uploaded to a HIPAA-compliant, secure file sharing platform hosted by Lurie Children's Hospital and maintained by Lurie Children's Hospital for at least 7 years per PCORI requirements. Lurie Children's Hospital will be responsible for responding to Data Sharing related inquiries.