BereavementNCT06136260
The Grief Navigation Trial: A Comparison of Two Interventions to Support Parents After Their Child's Unexpected or Traumatic Death
A study testing CommunityRx-Bereavement and General Bereavement Support Information in people with Bereavement, run by Ann & Robert H Lurie Children's Hospital of Chicago at 7 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bereavement
- What is being tested?
- CommunityRx-Bereavement and General Bereavement Support Information
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 7 sitesUnited States
- Study dates
- 4 Mar 2024to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Parents or caregivers unable to read or communicate in English or Spanish
- Parents or caregivers under the age of 18 years old
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Cook County Medical Examiner's Office
Chicago, Illinois, 60612
- Recruiting
Will County Coroner's Office
Joliet, Illinois, 60432
- Recruiting
Peoria County Coroner's Office
Peoria, Illinois, 61603
- Recruiting
Kane County Coroner's Office
Saint Charles, Illinois, 60175
- Recruiting
Lake County Coroner's Office
Waukegan, Illinois, 60085
- Recruiting
DuPage County Coroner's Office
Wheaton, Illinois, 60187
- Recruiting
McHenry County Coroner's Office
Woodstock, Illinois, 60098
About this study
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
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.
Read the 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:
- 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.
- Conditions
- Bereavement
- Being tested
- CommunityRx-Bereavement, General Bereavement Support Information
- Keywords
- grief, caregivers, community resources, pediatric, self-efficacy, coroners and medical examiners
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CommunityRx-BereavementOther
Also called CRx-B
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.
General Bereavement Support InformationOther
Also called GBSI
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.
| Study group | Role | What they receive |
|---|---|---|
| CommunityRx-Bereavement (CRx-B) | Experimental | Not described Receives: Other: CommunityRx-Bereavement |
| General Bereavement Support Information (GBSI) | Active comparator | Not described Receives: Other: General Bereavement Support Information |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: ~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.
Measured: ~6.5 months after child's death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start4 Mar 2024
- Primary completionJul 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BereavementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- University of Chicago, Patient-Centered Outcomes Research Institute, Missing Pieces, a program of the HAP Foundation
- Responsible party
- Principal investigator, Kelly Michelson, Ann & Robert H Lurie Children's Hospital of Chicago
- Investigators
- Kelly Michelson, MD, MPH, Principal investigator, Ann & Robert H Lurie Children's Hospital of ChicagoStacy Lindau, MD, MAPP, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06136260
- Sponsor's protocol ID
- 2023-6458
- Status last verified
- Jul 2026
- First submitted
- 11 Nov 2023
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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 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.
PubMed 40436312
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06136260
- Acronym / sponsor ID
- 2023-6458
- Conditions
- Bereavement
- Keywords
- grief, caregivers, community resources, pediatric, self-efficacy, coroners and medical examiners
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Collaborators
- University of Chicago, Patient-Centered Outcomes Research Institute, Missing Pieces, a program of the HAP Foundation
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CommunityRx-Bereavement (CRx-B) | Experimental | Other: CommunityRx-Bereavement |
| General Bereavement Support Information (GBSI) | Active comparator | Other: General Bereavement Support Information |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Parents or caregivers unable to read or communicate in English or Spanish
- Parents or caregivers under the age of 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CommunityRx-BereavementAlso: CRx-BThe 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. | Other | CommunityRx-Bereavement (CRx-B) |
| General Bereavement Support InformationAlso: GBSIThe 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. | Other | General Bereavement Support Information (GBSI) |
Primary outcome
Parent Self-efficacy for Finding Resources
Time frame: ~6.5 months after child's death
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."
Complicated Grief
Time frame: ~6.5 months after child's death
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Derived from this study: PubMed 40436312Agha 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kelly Michelson, MD, MPH principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago
Stacy Lindau, MD, MAPP principal investigator
University of Chicago
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CommunityRx-Bereavement and General Bereavement Support Information in people with Bereavement, run by Ann & Robert H Lurie Children's Hospital of Chicago at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kelly Michelson, MD, MPH (312-227-4800, kmichelson@luriechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parent Self-efficacy for Finding Resources (time frame: ~6.5 months after child's death). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06136260, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.