Parent SupportNCT06919601
Support Sessions for Parents With Children in the Pediatric Intensive Care Unit
A study testing Grief-Informed Healing Circles in people with Parent Support, run by Texas Woman's University at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if Grief-informed Parent Support sessions offered weekly to parents with a child in the pediatric intensive care unit work to decrease symptoms of parent grief compared to a non-grief informed parent support program offered weekly to parents with a child in the pediatric… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parent Support
- What is being tested?
- Grief-Informed Healing Circles
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2022to 30 Aug 2024
- 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
- Parent of a child in the pediatric intensive care unit
Who cannot join
- Not a parent of a child in the pediatric intensive care unit
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to learn if Grief-informed Parent Support sessions offered weekly to parents with a child in the pediatric intensive care unit work to decrease symptoms of parent grief compared to a non-grief informed parent support program offered weekly to parents with a child in the pediatric intensive care unit. The main question is:
Do parents with a child in the pediatric intensive care unit report fewer symptoms of grief, such as depression and anxiety, following their attendance at a parent support program with a grief-informed intervention compared to parents who receive a non-grief informed support program.
Read more
Participants will be randomized to :
Receive a 8-session grief-informed parent support program or a 8-session non grief-informed parent support program. Parents will report symptoms of grief before and after the 8-session parent support program.
Read the detailed description
Grief is the response to a loss. Infants and children in intensive care units are at increased risk for chronic morbidity and death. Grief is a normal response to the potential or actual loss of a child. Grief related disorders of Post-Traumatic Stress Disorder (PTSD), anxiety, depression, and insomnia are reported by parents of children in PICU's.
To test the efficacy and impact of a grief-informed intervention, 100 parents of infants and children admitted to a PICU were recruited, within the first 7 days of admission. Fifty parents were randomized to 8, 1-hour grief informed sessions, led by a trained facilitator that followed a curriculum of validating grief and inviting each parent to share their grief.
Fifty parents were randomized to 8, 1-hr attention control sessions, led by a registered nurse, who offered guided imagery, meditation, and chair-based exercises. Attendance at sessions was recorded to establish dose and intervention efficacy. Following the 8 sessions, parents were administered the Parent Experiences Questionnaire (PEQ) to measure the 4 domains of: Unresolved Sorrow and Anger, Guilt and Worry, Long-Term Uncertainty, and Emotional Resources. Sixty-Four (64) parents completed the PEQ measure. Thirty-eight (38) of the 63 parents joined a second study to measure the PEQ four domains and parent and sibling behavioral functioning every 3 months for 12 months. A final qualitative interview will be offered to each parent completing the study (estimated 30 parents) and qualitative data triangulated with PEQ scores.
Attendance at the grief informed, Healing Circles Intervention, sessions was TWICE that of the attention control sessions. The differential scores of the four domains of the Parent Experiences Questionnaire were measured at 2 weeks after last session and at 3-, 6-, 9-, and 12 months. The PEQ four domain and total scores were correlated to Parent and Sibling functioning, as measured on the Adult and Child Behavior Checklist, respectively. Behavior functioning scores were scored as pre-clinical/clinical behaviors and non-clinical behaviors. All data was modeled to learn predictive patterns to best inform clinical practices for siblings and parents of children in the Pediatric Intensive Care Unit (PICU).
- Conditions
- Parent Support
- Being tested
- Grief-Informed Healing Circles
- Keywords
- parents grief intensive care support, death of child, death, grief, parent, child
- Medical subject headings
- Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grief-Informed Healing CirclesBehavioural
Eight one-hour sessions delivered in a group setting
| Study group | Role | What they receive |
|---|---|---|
| Support Sessions for Parents on Expressing Grief | Experimental | Parents in the experiment group will receive 8 Grief-informed support sessions. Each session is curriculum driven and completed in a group session. each session lasts 1 hour. Each session will be delivered by a trained person in grief and loss. Receives: Behavioral: Grief-Informed Healing Circles |
What is being measured
The primary outcome is the main question the study is designed to answer.
parent grief
number of parent grief symptoms, such as depression and anxiety
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start2 Dec 2022
- Primary completion30 Jun 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parent SupportStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Woman's University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Judith M McFarlane, DrPH, Principal investigator, Texas Woman's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06919601
- Sponsor's protocol ID
- IRB-FY2022-338
- Status last verified
- Apr 2025
- First submitted
- 2 Apr 2025
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: outcome measure of parent grief and 8-session grief-informed intervention
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Support Sessions for Parents With Children in the Pediatric Intensive Care Unit
- ClinicalTrials.gov ID
- NCT06919601
- Acronym / sponsor ID
- IRB-FY2022-338
- Conditions
- Parent Support
- Keywords
- parents grief intensive care support, death of child, death, grief, parent, child
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Texas Woman's UniversityUniversity, hospital or other
- Study start
- 2 Dec 2022 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 9 Apr 2025 (actual)
- 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.
The goal of this clinical trial is to learn if Grief-informed Parent Support sessions offered weekly to parents with a child in the pediatric intensive care unit work to decrease symptoms of parent grief compared to a non-grief informed parent support program offered weekly to parents with a child in the pediatric intensive care unit. The main question is:
Do parents with a child in the pediatric intensive care unit report fewer symptoms of grief, such as depression and anxiety, following their attendance at a parent support program with a grief-informed intervention compared to parents who receive a non-grief informed support program.
Participants will be randomized to :
Receive a 8-session grief-informed parent support program or a 8-session non grief-informed parent support program. Parents will report symptoms of grief before and after the 8-session parent support program.
Detailed description
Grief is the response to a loss. Infants and children in intensive care units are at increased risk for chronic morbidity and death. Grief is a normal response to the potential or actual loss of a child. Grief related disorders of Post-Traumatic Stress Disorder (PTSD), anxiety, depression, and insomnia are reported by parents of children in PICU's.
To test the efficacy and impact of a grief-informed intervention, 100 parents of infants and children admitted to a PICU were recruited, within the first 7 days of admission. Fifty parents were randomized to 8, 1-hour grief informed sessions, led by a trained facilitator that followed a curriculum of validating grief and inviting each parent to share their grief.
Fifty parents were randomized to 8, 1-hr attention control sessions, led by a registered nurse, who offered guided imagery, meditation, and chair-based exercises. Attendance at sessions was recorded to establish dose and intervention efficacy. Following the 8 sessions, parents were administered the Parent Experiences Questionnaire (PEQ) to measure the 4 domains of: Unresolved Sorrow and Anger, Guilt and Worry, Long-Term Uncertainty, and Emotional Resources. Sixty-Four (64) parents completed the PEQ measure. Thirty-eight (38) of the 63 parents joined a second study to measure the PEQ four domains and parent and sibling behavioral functioning every 3 months for 12 months. A final qualitative interview will be offered to each parent completing the study (estimated 30 parents) and qualitative data triangulated with PEQ scores.
Attendance at the grief informed, Healing Circles Intervention, sessions was TWICE that of the attention control sessions. The differential scores of the four domains of the Parent Experiences Questionnaire were measured at 2 weeks after last session and at 3-, 6-, 9-, and 12 months. The PEQ four domain and total scores were correlated to Parent and Sibling functioning, as measured on the Adult and Child Behavior Checklist, respectively. Behavior functioning scores were scored as pre-clinical/clinical behaviors and non-clinical behaviors. All data was modeled to learn predictive patterns to best inform clinical practices for siblings and parents of children in the Pediatric Intensive Care Unit (PICU).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Support Sessions for Parents on Expressing Grief | Experimental | Behavioral: Grief-Informed Healing CirclesParents in the experiment group will receive 8 Grief-informed support sessions. Each session is curriculum driven and completed in a group session. each session lasts 1 hour. Each session will be delivered by a trained person in grief and loss. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Parent of a child in the pediatric intensive care unit
Key exclusion criteria (1 listed)
- Not a parent of a child in the pediatric intensive care unit
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 |
|---|---|---|
| Grief-Informed Healing CirclesEight one-hour sessions delivered in a group setting | Behavioural | Support Sessions for Parents on Expressing Grief |
Primary outcome
parent grief
Time frame: 12 months
number of parent grief symptoms, such as depression and anxiety
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 10 Apr 2025.
- Individual participant dataSharing planned: Yes. outcome measure of parent grief and 8-session grief-informed intervention
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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.
Judith M McFarlane, DrPH principal investigator
Texas Woman's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Grief-Informed Healing Circles in people with Parent Support, run by Texas Woman's University 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 1 inclusion and 1 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 10 Apr 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?
parent grief (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Apr 2025.