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

Bereavement Clinical Trial

Official title:

The Missing Pieces Trial: A Multi-Site Pragmatic Comparative Effectiveness Trial of Interventions to Support Parents After Their Child's Unexpected or Traumatic Death

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06136260
• Other study ID #: 2023-6458
• Status: Recruiting
• Phase: N/A
• Start date: March 4, 2024
• Est. completion date: February 2028

Study information

• Verified date: March 2024
• Source: Ann & Robert H Lurie Children's Hospital of Chicago
• Contact: Kelly Michelson, MD, MPH
• Phone: 312-227-4800
• Email: kmichelson[@]luriechildrens.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: February 2028
• Est. primary completion date: July 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bereavement

Intervention

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 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 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, 6, and 12 months after the child's death.

Locations

Country	Name	City	State
United States	Cook County Medical Examiner's Office	Chicago	Illinois
United States	Will County Coroner's Office	Joliet	Illinois
United States	Kane County Coroner's Office	Saint Charles	Illinois
United States	Lake County Coroner's Office	Waukegan	Illinois
United States	DuPage County Coroner's Office	Wheaton	Illinois
United States	McHenry County Coroner's Office	Woodstock	Illinois

Sponsors (4)

Lead Sponsor	Collaborator
Ann & Robert H Lurie Children's Hospital of Chicago	Missing Pieces, a program of the HAP Foundation, Patient-Centered Outcomes Research Institute, University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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