GriefNCT01926080
Impact of a Neonatal-Bereavement-Support DVD on Grief
A study testing DVD Intervention Arm in people with Grief and Depressive Symptoms, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Experts agree that neonatal death has long-term impact on parents. Many parents experience sadness, pain, anger, bouts of crying, and a depressed mood after the death of a child. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Grief, Depressive Symptoms
- What is being tested?
- DVD Intervention Arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to 9 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- At least 18 years of age
- Any parent who has experienced the death of a baby in the NICU at SLCH or has had a baby treated in the NICU who has died at home with hospice care
Who cannot join
- Babies who are at home longer than one month with hospice care will be excluded
- Those who are not English speaking or who are illiterate
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: End-of-Life Care in the NICU: Does Bereavement Support Make a Difference?
Experts agree that neonatal death has long-term impact on parents. Many parents experience sadness, pain, anger, bouts of crying, and a depressed mood after the death of a child. There are no prospective studies that evaluate the effectiveness of bereavement management and follow-up on the grief process following the death of a newborn. The purpose of this study is to evaluate the impact of a neonatal intensive care unit (NICU) bereavement support program and the use of a newly designed family-centered bereavement DVD. This educational DVD includes personal interviews with parents, grandparents and siblings who have experienced the lost of a baby in the NICU.
Read the detailed description
The care given to a family before and following a neonatal loss can set the stage for a family's entire grieving process. For many parents, the support they receive from health care providers after the loss of a baby may have crucial effects on the family's ability to appropriately respond. It is essential for nurses, practitioners, physicians, and chaplains to provide compassionate care that meets or exceeds parents' expectations. However, supporting families following the death of an infant is particularly challenging. There is limited bereavement intervention guidance in the literature that may benefit grieving parents. Follow-up care is a crucial part of bereavement management of families whose babies have died. The bereavement committee at St. Louis Children's Hospital (SLCH) is a multi-disciplinary team, which includes representation from neonatal nurses and nurse practitioners, neonatologists, social workers, chaplains, patient-care associates, and former bereaved parents. Their role is to assist families both at the time of an infant's death and in securing their baby's personal belongings after the family leaves the hospital. In addition to receiving bereavement materials, which is considered standard-practice of care in the NICU at SLCH following the death of an infant, half of the parents enrolled in the study will be prospectively randomized to receive the educational bereavement DVD entitled 'Grieving in the NICU- Mending Broken Hearts When a Baby Dies Too Soon'.
- Conditions
- Grief, Depressive Symptoms
- Being tested
- DVD Intervention Arm
- Keywords
- Depression, Spirituality, Neonatal death, Bereavement, Randomized controlled trial
- Medical subject headings
- Depression, Perinatal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DVD Intervention ArmOther
Half of the parents will be prospectively randomized to receive the educational bereavement DVD entitled 'Grieving in the NICU- Mending Broken Hearts When a Baby Dies Too Soon'. A specific aim of the study is to evaluate the additional benefit of the Bereavement DVD over standard bereavement care in reducing parents' grief by comparing level of grief at each time point between the intervention (DVD) and control (no DVD) group.
| Study group | Role | What they receive |
|---|---|---|
| DVD Intervention Arm | Other | Half of the parents will be prospectively randomized to receive the educational bereavement DVD entitled 'Grieving in the NICU- Mending Broken Hearts When a Baby Dies Too Soon'. A specific aim of the study is to evaluate the additional benefit of the Bereavement DVD over standard bereavement care in reducing parents' grief by comparing level of grief at each time point between the intervention (DVD) and control (no DVD) group. Receives: Other: DVD Intervention Arm |
| Standard Bereavement Care | No intervention | Those randomized to control group (no DVD) Standard Bereavement Care Arm receive the bereavement materials given to families as standard-practice of care in the NICU at SLCH following the death of an infant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parental Grief
To characterize and describe changes in grief at 3 months and 12 months in a cohort of parents who have experienced death of a newborn infant in the NICU.
Measured: 3 and 12 months following death of a newborn
Secondary outcomes (1)
Depressive Mood Symptoms
To characterize and describe changes in depressive mood symptoms at 3 months and 12 months in a cohort of parents who have experienced death of a newborn infant in the NICU.
Measured: 3 and 12 months following death of a newborn
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2013 (estimated)
- Study startJan 2008
- Primary completionFeb 2011
- Study completion9 Aug 2017
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 GriefStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01926080
- Sponsor's protocol ID
- 201108060
- Other IDs
- P30CA091842
- Status last verified
- Jan 2025
- First submitted
- 16 Aug 2013
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rosenbaum JL, Smith JR, Yan Y, Abram N, Jeffe DB. Impact of a Neonatal-Bereavement-Support DVD on Parental Grief: A Randomized Controlled Trial. Death Stud. 2015 Jan-Jun;39(1-5):191-200. doi: 10.1080/07481187.2014.946628. Epub 2014 Dec 20.
PubMed 25530502
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- End-of-Life Care in the NICU: Does Bereavement Support Make a Difference?
- ClinicalTrials.gov ID
- NCT01926080
- Acronym / sponsor ID
- 201108060
- Conditions
- Grief, Depressive Symptoms
- Keywords
- Depression, Spirituality, Neonatal death, Bereavement, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Feb 2011 (actual)
- Study completion
- 9 Aug 2017 (actual)
- First posted
- 20 Aug 2013 (estimated)
- 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.
Experts agree that neonatal death has long-term impact on parents. Many parents experience sadness, pain, anger, bouts of crying, and a depressed mood after the death of a child. There are no prospective studies that evaluate the effectiveness of bereavement management and follow-up on the grief process following the death of a newborn. The purpose of this study is to evaluate the impact of a neonatal intensive care unit (NICU) bereavement support program and the use of a newly designed family-centered bereavement DVD. This educational DVD includes personal interviews with parents, grandparents and siblings who have experienced the lost of a baby in the NICU.
Detailed description
The care given to a family before and following a neonatal loss can set the stage for a family's entire grieving process. For many parents, the support they receive from health care providers after the loss of a baby may have crucial effects on the family's ability to appropriately respond. It is essential for nurses, practitioners, physicians, and chaplains to provide compassionate care that meets or exceeds parents' expectations. However, supporting families following the death of an infant is particularly challenging. There is limited bereavement intervention guidance in the literature that may benefit grieving parents. Follow-up care is a crucial part of bereavement management of families whose babies have died. The bereavement committee at St. Louis Children's Hospital (SLCH) is a multi-disciplinary team, which includes representation from neonatal nurses and nurse practitioners, neonatologists, social workers, chaplains, patient-care associates, and former bereaved parents. Their role is to assist families both at the time of an infant's death and in securing their baby's personal belongings after the family leaves the hospital. In addition to receiving bereavement materials, which is considered standard-practice of care in the NICU at SLCH following the death of an infant, half of the parents enrolled in the study will be prospectively randomized to receive the educational bereavement DVD entitled 'Grieving in the NICU- Mending Broken Hearts When a Baby Dies Too Soon'.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DVD Intervention Arm | Other | Other: DVD Intervention ArmHalf of the parents will be prospectively randomized to receive the educational bereavement DVD entitled 'Grieving in the NICU- Mending Broken Hearts When a Baby Dies Too Soon'. A specific aim of the study is to evaluate the additional benefit of the Bereavement DVD over standard bereavement care in reducing parents' grief by comparing level of grief at each time point between the intervention (DVD) and control (no DVD) group. |
| Standard Bereavement Care | No intervention | –Those randomized to control group (no DVD) Standard Bereavement Care Arm receive the bereavement materials given to families as standard-practice of care in the NICU at SLCH following the death of an infant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- At least 18 years of age
- Any parent who has experienced the death of a baby in the NICU at SLCH or has had a baby treated in the NICU who has died at home with hospice care
Key exclusion criteria (2 listed)
- Babies who are at home longer than one month with hospice care will be excluded
- Those who are not English speaking or who are illiterate
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 |
|---|---|---|
| DVD Intervention ArmHalf of the parents will be prospectively randomized to receive the educational bereavement DVD entitled 'Grieving in the NICU- Mending Broken Hearts When a Baby Dies Too Soon'. A specific aim of the study is to evaluate the additional benefit of the Bereavement DVD over standard bereavement care in reducing parents' grief by comparing level of grief at each time point between the intervention (DVD) and control (no DVD) group. | Other | DVD Intervention Arm |
Primary outcome
Parental Grief
Time frame: 3 and 12 months following death of a newborn
To characterize and describe changes in grief at 3 months and 12 months in a cohort of parents who have experienced death of a newborn infant in the NICU.
1 secondary outcome
Depressive Mood Symptoms
Time frame: 3 and 12 months following death of a newborn
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Derived from this study: PubMed 25530502Rosenbaum JL, Smith JR, Yan Y, Abram N, Jeffe DB. Impact of a Neonatal-Bereavement-Support DVD on Parental Grief: A Randomized Controlled Trial. Death Stud. 2015 Jan-Jun;39(1-5):191-200. doi: 10.1080/07481187.2014.946628. Epub 2014 Dec 20.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DVD Intervention Arm in people with Grief and Depressive Symptoms, run by Washington University School of Medicine at 1 site 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 2 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: finished, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parental Grief (time frame: 3 and 12 months following death of a newborn). 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 NCT01926080, 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 7 Jan 2025.