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

Study Overview
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Brief Summary
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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
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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 months after their child dies.

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

Conditions
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Bereavement

Intervention / Treatment
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* Other: CommunityRx-Bereavement
* Other: General Bereavement Support Information


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parents or legal 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 legal caregivers who provide permission to the ME to be referred to Missing Pieces Parent or legal caregivers who are referred to Missing Pieces by a ME Parents or legal caregivers able to read and communicate in English or Spanish Exclusion Criteria: Parents or legal caregivers unable to read or communicate in English or Spanish Parents or legal caregivers under the age of 18 years old

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CommunityRx-Bereavement (CRx-B)<br> | Other: CommunityRx-Bereavement<br>* 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 call the parent; 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, calls from the Grief Navigator to occur at least 3, 6, and 12 months after the child's death.<br>* Other names: CRx-B;|
| Active Comparator: General Bereavement Support Information (GBSI)<br> | Other: General Bereavement Support Information<br>* 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 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.<br>* Other names: GBSI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 in your community that help you manage your grief? Responses are on a 5-point Likert scale ranging from not at all confident to completely confident. |  6 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 months after child's death | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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grief, caregivers, community resources, pediatric, self-efficacy, coroners and medical examiners