Bereavement Support Strategies for Grief After Child Loss

Recruiting at 7 trial locations

Overseen By Carolyn Sutter, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

Disqualifiers: Non-English/Spanish speakers, Under 18

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

2000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find better ways to support parents grieving the sudden or unexpected loss of a child, such as through suicide or overdose. Researchers will compare two strategies: a program called CommunityRx-Bereavement and general bereavement support information. The goal is to determine which method helps parents cope more effectively during this difficult time. Parents or caregivers who have experienced such a loss and have interacted with a medical examiner or coroner in certain Illinois counties might be eligible to participate.

As an unphased trial, this study offers participants the opportunity to contribute to developing new support strategies for grieving parents.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these bereavement support strategies are safe for grieving parents?

Research has shown that both CommunityRx-Bereavement (CRx-B) and General Bereavement Support Information (GBSI) receive positive feedback from participants. These programs aim to support parents after the loss of a child. CommunityRx-Bereavement includes a Grief Navigator who contacts parents with information and support, while General Bereavement Support offers more general assistance.

Previous studies have not reported any major safety issues or negative effects with either approach, indicating that these programs are safe for participants. They are designed to provide emotional support, which typically involves very low physical risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial on bereavement support strategies because it explores innovative approaches to help individuals coping with the profound grief of losing a child. The CommunityRx-Bereavement (CRx-B) program is unique because it tailors support resources to the specific needs of each bereaved individual, potentially offering more personalized care than standard bereavement support, which often involves general counseling or support groups. Meanwhile, the General Bereavement Support Information (GBSI) serves as an active comparator, providing comprehensive information that helps participants understand and manage their grief. This trial aims to reveal which approach better supports healing and adjustment, offering hope for more effective coping strategies in the future.

What evidence suggests that this trial's treatments could be effective for grief after child loss?

Research has shown that the CommunityRx-Bereavement (CRx-B) program, a treatment in this trial, is a new, proven method to help grieving parents. It is easy to use and can be expanded to assist many people. The program connects parents with resources to support them after the unexpected or traumatic loss of a child. In contrast, the General Bereavement Support Information (GBSI), another treatment arm in this trial, offers more traditional support by providing general advice and resources for dealing with grief. This trial tests both approaches to determine which one better helps parents cope with their loss. ^{1 3 6 7 8}

Who Is on the Research Team?

Kelly Michelson, MD, MPH

Principal Investigator

Lurie Children's Hospital

Stacy Lindau, MD, MAPP

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

This trial is for parents or legal caregivers who have lost a child under 25 years old to unexpected or traumatic events, and are referred by medical examiners. Participants must be able to communicate in English or Spanish and give permission to the ME for referral. Those unable to understand these languages or under 18 cannot join.

Inclusion Criteria

I am the parent or legal caregiver of a minor under 25 involved in a medical examiner case.

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

Exclusion Criteria

Parents or legal caregivers unable to read or communicate in English or Spanish

I am a parent or caregiver under 18.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive either CommunityRx-Bereavement (CRx-B) or General Bereavement Support Information (GBSI) to support parents after a child's unexpected or traumatic death

6.5 months

Surveys conducted approximately 6.5 months after child's death

Follow-up

Participants are monitored for self-efficacy in finding resources and symptoms of complicated grief

6.5 months

What Are the Treatments Tested in This Trial?

Interventions

• CommunityRx-Bereavement
• General Bereavement Support Information

Trial Overview The study compares two support strategies for grieving parents post-child loss: General Bereavement Support Information versus CommunityRx-Bereavement, aiming to address the healthcare system's gap in aiding families during such crises.

How Is the Trial Designed?

Group I: CommunityRx-Bereavement (CRx-B) Experimental Treatment 1 Intervention

Group II: General Bereavement Support Information (GBSI) Active Control 1 Intervention

Who Is Running the Clinical Trial?

Ann & Robert H Lurie Children's Hospital of Chicago

Lead Sponsor

Trials

275

Recruited

5,182,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

University of Chicago

Collaborator

Trials

1,086

Recruited

844,000+

Missing Pieces, a program of the HAP Foundation

Collaborator

Trials

1

Recruited

2,000+

Published Research Related to This Trial

A systematic review of 74 studies on bereavement interventions found that while pharmacotherapy is effective for treating bereavement-related depression, other therapeutic approaches lack consistent evidence of benefit.

The review highlights significant challenges in establishing effective bereavement care, including variability in study designs and insufficient reporting, which hinder the development of evidence-based recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bereavement care interventions: a systematic review. Forte, AL., Hill, M., Pazder, R., et al.[2019]

A systematic review of bereavement support programs for parents who lost a child found no overall benefit from these interventions, based on three controlled studies from 1990 to 2001.

However, highly distressed mothers showed significant reductions in psychological symptoms and marital dysfunction, suggesting that targeted support may be more effective for certain individuals rather than a one-size-fits-all approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do interventions make a difference to bereaved parents? A systematic review of controlled studies. Rowa-Dewar, N.[2018]

Bereavement support is crucial in critical care settings, as it can significantly impact families after the loss of a loved one in the ICU.

The review suggests that effective bereavement programs should include tangible resources like brochures and memory-making activities, and utilize a bereavement risk assessment tool to tailor support to families' specific needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bereavement Care in the Adult Intensive Care Unit: Directions for Practice. Erikson, A., McAdam, J.[2021]

Recent research has improved understanding of bereavement care, helping clinicians distinguish between normal grief and Complicated Grief Disorder, which can lead to better identification and support for vulnerable individuals.

New psychotherapies for Complicated Grief Disorder have shown clinical efficacy, but more research is needed to enhance detection of at-risk individuals and to develop tailored interventions that address underlying attachment issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Update on bereavement research: evidence-based guidelines for the diagnosis and treatment of complicated bereavement. Zhang, B., El-Jawahri, A., Prigerson, HG.[2007]

The article provides a comprehensive overview of grief support in Pediatric Palliative Care, addressing anticipatory grief, grief at the time of death, and post-death bereavement support.

It emphasizes the importance of evolving grief support methods based on current grief theory and research, aiming to enhance the effectiveness of programs for families dealing with pediatric illness and loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current Grief Support in Pediatric Palliative Care. Schuelke, T., Crawford, C., Kentor, R., et al.[2023]

The death of a child is an extremely challenging experience for parents, highlighting the need for effective bereavement care in hospitals, which is currently inconsistent across facilities.

Boston Children's Hospital has developed a comprehensive bereavement program focused on education, guidance, and support, advocating for all pediatric hospitals to adopt similar programs as a standard practice to better assist grieving families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Development of a Hospital-Wide Bereavement Program: Ensuring Bereavement Care for All Families of Pediatric Patients. Morris, SE., Dole, OR., Joselow, M., et al.[2018]

A series of bereavement support groups for children and parents, developed after the loss of a loved one to cancer, effectively reduced anxiety and feelings of isolation associated with grief.

These groups not only facilitated family communication and healing but also ensured continuity of care within the outpatient cancer care program, highlighting their importance in supporting families during difficult times.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A bereavement support group for children: fostering communication about grief and healing. Mulcahey, AL., Young, MA.[2004]

Bereavement care in critical care units is essential and should include support and counseling for family members before and after a patient's death, as well as follow-up support in the months following the loss.

This approach recognizes the significant emotional transition family members undergo from anticipating a loss to experiencing bereavement, highlighting the need for comprehensive care during these critical moments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bereavement care in the critical care setting. Warren, NA.[2004]

A review of eight studies on bereavement camps for children indicates that these camps are effective interventions for helping children cope with grief and build resilience after loss.

Despite variations in camp structure and theoretical approaches, many camps share common goals and activities that contribute to positive outcomes for bereaved children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are children's grief camps effective? Clute, MA., Kobayashi, R.[2013]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40436312/

The Grief Navigation Trial: A multi-site pragmatic ... This comparative effectiveness trial will test two strategies that help parents and caregivers find support after traumatic or unexpected pediatric death.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1551714425001569

The Grief Navigation Trial: A multi-site pragmatic ... This comparative effectiveness trial will test two strategies that help parents and caregivers find support after traumatic or unexpected pediatric death.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06136260

Study Details | NCT06136260 | The Grief Navigation Trial: ... Study Overview · CommunityRx-Bereavement (CRx-B), an evidence- and theory-based, low intensity, highly scalable intervention, and · General bereavement support ...

4. withpower.com withpower.com/trial/bereavement-support-strategies-for-grief-after-child-loss-d7c69

Bereavement Support Strategies for Grief After Child Loss Trial Overview The study compares two support strategies for grieving parents post-child loss: General Bereavement Support Information versus CommunityRx- ...

5. aapexperience24.eventscribe.net aapexperience24.eventscribe.net/ajaxcalls/PosterInfo.asp?PosterID=681016

P3.E097: Study Protocol for the Missing Pieces Trial Our aim was to compare the effectiveness of two interventions provided by Missing Pieces: (1) CommunityRx-Bereavement ... grief support organizations.

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06136260/the-grief-navigation-trial-a-comparison-of-two-interventions-to-support-parents-after-their-childs-unexpected-or-traumatic-death

A Comparison of Two Interventions to Support Parents ... CommunityRx-Bereavement (CRx-B), an evidence- and theory-based, low intensity, highly scalable intervention, and. General bereavement support ...

7. scholars.northwestern.edu scholars.northwestern.edu/en/publications/the-grief-navigation-trial-a-multi-site-pragmatic-comparative-eff

A multi-site pragmatic comparative effectiveness trial of two ... This comparative effectiveness trial will test two strategies that help parents and caregivers find support after traumatic or unexpected pediatric death.

8. instagram.com instagram.com/p/DMsWkQtsiMr/

Parents who lose children to traumatic deaths often face ... This clinical trial evaluates two interventions: CommunityRx-Bereavement and General Bereavement Support. In a randomized trial, parents will be ...