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NCT Number: NCT06136260

The Grief Navigation Trial: A Comparison of Two 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.

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Key information

Conditions

Bereavement

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cook County Medical Examiner's Office, Chicago, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CommunityRx-Bereavement

Other

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.

Other names: CRx-B

General Bereavement Support Information

Other

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.

Other names: GBSI

Primary outcomes

  1. 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."

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Carolyn Sutter, PhD

CONTACT

[email protected]

312-227-7059

Kelly Michelson, MD, MPH

CONTACT

[email protected]

312-227-4800

Sponsors and collaborators

Lead sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Other

Collaborators

  • Missing Pieces, a program of the HAP Foundation
  • Patient-Centered Outcomes Research Institute
  • University of Chicago

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Nov 18, 2023
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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