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Trial registered on ANZCTR


Registration number
ACTRN12625000539437
Ethics application status
Approved
Date submitted
24/04/2025
Date registered
28/05/2025
Date last updated
28/05/2025
Date data sharing statement initially provided
28/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
The FOOTPRINTS Project Phase Two: Follow-On Outreach - Psychosocial Support after the Unexpected Death of a Child in a Paediatric Intensive Care Unit (PICU)
Scientific title
The FOOTPRINTS Project Phase Two: Follow-On Outreach - Psychosocial Support after the Unexpected Death of a Child in PICU
Secondary ID [1] 314282 0
None
Universal Trial Number (UTN)
Trial acronym
FOOTPRINTS
Linked study record
ACTRN12623001295639 This record is the first phase of the FOOTPRINTS Project.

Health condition
Health condition(s) or problem(s) studied:
Bereavement 337224 0
Grief 337449 0
Child sudden and unexpected death 337223 0
Condition category
Condition code
Public Health 333631 333631 0 0
Health service research
Mental Health 333822 333822 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be a PICU bereavement service - the FOOTPRINTS Service - designed in Phase One of the FOOTPRINTS Project. The FOOTPRINTS Service will systematically follow-up and support families of children who have died in PICU from sudden and unexpected causes who are not already linked to specialist palliative care service. The service will be offered by a PICU liaison nurse and critical care social worker who will work together to provide a systematic program of follow-up, with regular contact time-points, focused on transitional support, coordinating elements of bereavement support and linking families to community services. Outreach contact will be offered via telephone, text, or email depending on the preference of participating family members, at the following time-points:
1) In PICU around the time of death
2) 2 weeks post bereavement
3) 3 months post bereavement
4) 6 months post bereavement
5) 12 months post bereavement
* Research measures administered at 13 months post bereavement.
The duration of outreach contact will vary depending on the level of response from participating family members, but is expected to range between 15 - 45 minutes. Families will be offered links to community services relevant to their unique grief circumstances as assessed by the FOOTPRINTS liaison nurse and social worker, such as professional grief counselling services and peer support groups. In addition, all participating families will be able to view links to a wide range of community services available on the FOOTPRINTS Project website, which will go live at the commencement of the service and will be regularly updated to reflect current community bereavement offerings including community-led peer support services in addition to professional service providers. An Intervention Delivery Checklist will be maintained for each service contact time-point to capture the extent the intervention is delivered as planned, along with a Telephone / Contact Log to record the extent to which family members receive contact and interact with the intervention providers. A Resource Utilisation Checklist will also be maintained to record the uptake and utilisation of community resources advised by the intervention providers.
Participants from the FOOTPRINTS Project - Phase One will be invited to be involved in Phase Two as Consumer Advisors but not as participants.
Intervention code [1] 330892 0
Treatment: Other
Comparator / control treatment
The control group will consist of family members of children who died before the FOOTPRINTS Service commenced and therefore received usual care bereavement support and follow-up. Each site will select a control group identified via review of ANZPIC Registry Data from a 5-year period prior to the commencement of the FOOTPRINTS Service. This period is anticipated to be from 01/07/2020 to 31/06/2025 but may differ site-to-site dependent on the timing of governance approval
Control group
Historical

Outcomes
Primary outcome [1] 341206 0
Grief Intensity
Timepoint [1] 341206 0
13 months post bereavement
Secondary outcome [1] 446770 0
Family functioning
Timepoint [1] 446770 0
13 months post bereavement
Secondary outcome [2] 446771 0
Post Traumatic Stress Disorder
Timepoint [2] 446771 0
13 months post bereavement
Secondary outcome [3] 446772 0
Implementation: Feasibility
Timepoint [3] 446772 0
After enrolment of the first five families at each site
Secondary outcome [4] 446773 0
Implementation: Fidelity
Timepoint [4] 446773 0
Every service contact timepoint
Secondary outcome [5] 447483 0
Implementation: Translatability
Timepoint [5] 447483 0
End of study

Eligibility
Key inclusion criteria
Inclusion Criteria –Baseline Cohort:
Any person who:
a) considers themselves a close family member of a child who has died unexpectedly in PICU within the preceding five years, and
b) has the capacity to complete the study assessments.

Inclusion Criteria – Intervention Cohort:
Any person who:
a) considers themselves a close family member of a child who has died unexpectedly in PICU, and
b) has received contact from the FOOTPRINTS Service, or
c) interacted with the FOOTPRINTS Service materials, or
d) utilised community services facilitated by FOOTPRINTS personnel, and
e) has the capacity to complete the study assessments.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria – Both cohorts:
Family members of children already receiving pre-existing palliative care services prior to the time of death.

Discretionary Exclusion Criteria:
Situations involving:
a) Inflicted injuries
b) Disputed Custody
c) Active criminal investigations
– as documented in hospital notes from the time of death.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
A historical control will be utilised with each site recruiting their own control group. Controls will be participants who experienced the unexpected death of a child before the introduction of the FOOTPRINTS Service.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Comparison of the demographic and clinical characteristics of each group (baseline and intervention) will be undertaken using standard approaches (mean/standard deviation; median/interquartile range; number/percentage). Relationships among participants and between participants and child deaths in PICU will be described. Differences in baseline characteristics that may have an association with the primary outcome include relationship of participants to the deceased child, age of the deceased child at the time of death, and presence of complex trauma (including multiple deaths or injuries within the family at the time of the child’s death, or previous child death within the family). Due to the non-randomised nature of the data, exploratory statistical comparisons of the baseline characteristics between the two study groups will be reported to inform the use of covariates in the primary analysis. This will be achieved through multilevel mixed effect regression models (accounting for site and child as clusters) and report effect differences and 95% confidence levels. Should significant imbalance between the two groups exist, the use of propensity score matching will be explored to derive balanced cohorts.

The primary analysis will be conducted on a modified intention-to-treat cohort for the intervention group, i.e. regardless of how much of the intervention bundle is received, the intervention group will be analysed as the intervention cohort. Statistical analysis of the primary outcome will be undertaken using multilevel mixed effects regression, accounting for site and family clustering through random effects, and treatment group as the fixed effects. The effect estimate, 95% confidence interval, and p-value will be reported. A priori planned sensitivity analyses will be undertaken as follows: 1) adjusting for unbalanced characteristics in the cohort; 2) restricting the baseline cohort to participants within the time window of 13 – 15 months post bereavement; and 3) a modified per-protocol analysis including participants in the intervention group who adhered to the intervention as prescribed. Secondary outcomes will be analysed using similar approaches, however p-values will not be reported.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2025
Actual
Date of last participant enrolment
Anticipated
1/07/2027
Actual
Date of last data collection
Anticipated
1/08/2028
Actual
Sample size
Target
106
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA,VIC

Funding & Sponsors
Funding source category [1] 318802 0
Charities/Societies/Foundations
Name [1] 318802 0
Stan Perron Charitable Foundation
Country [1] 318802 0
Australia
Funding source category [2] 318803 0
Government body
Name [2] 318803 0
Government of Western Australia Department of Health - Futures Health and Research Innovation Fund
Country [2] 318803 0
Australia
Funding source category [3] 318799 0
Charities/Societies/Foundations
Name [3] 318799 0
Perth Children's Hospital Foundation
Country [3] 318799 0
Australia
Primary sponsor type
Government body
Name
Child and Adolescent Health Service Western Australia
Address
Country
Australia
Secondary sponsor category [1] 321244 0
Hospital
Name [1] 321244 0
Perth Children's Hospital
Address [1] 321244 0
Country [1] 321244 0
Australia
Other collaborator category [1] 283500 0
Hospital
Name [1] 283500 0
Monash Children's Hospital
Address [1] 283500 0
Country [1] 283500 0
Australia
Other collaborator category [2] 283501 0
Hospital
Name [2] 283501 0
John Hunter Children's Hospital
Address [2] 283501 0
Country [2] 283501 0
Australia
Other collaborator category [3] 283503 0
Hospital
Name [3] 283503 0
Sydney Children's Hospital Westmead
Address [3] 283503 0
Country [3] 283503 0
Australia
Other collaborator category [4] 283499 0
University
Name [4] 283499 0
Curtin University
Address [4] 283499 0
Country [4] 283499 0
Australia
Other collaborator category [5] 283502 0
Hospital
Name [5] 283502 0
Royal Children's Hospital Melbourne
Address [5] 283502 0
Country [5] 283502 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317407 0
Child and Adolescent Health Service Human Research Ethics Committee
Ethics committee address [1] 317407 0
Ethics committee country [1] 317407 0
Australia
Date submitted for ethics approval [1] 317407 0
06/11/2023
Approval date [1] 317407 0
07/12/2023
Ethics approval number [1] 317407 0
RGS000006539

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 140966 0
Mrs Arielle Jolly
Address 140966 0
Child and Adolescent Health Service 15 Hospital Ave Nedlands WA 6009
Country 140966 0
Australia
Phone 140966 0
+61 401008874
Fax 140966 0
Email 140966 0
[email protected]
Contact person for public queries
Name 140967 0
Arielle Jolly
Address 140967 0
Child and Adolescent Health Service 15 Hospital Ave Nedlands WA 6009
Country 140967 0
Australia
Phone 140967 0
+61 401008874
Fax 140967 0
Email 140967 0
[email protected]
Contact person for scientific queries
Name 140968 0
Arielle Jolly
Address 140968 0
Child and Adolescent Health Service 15 Hospital Ave Nedlands WA 6009
Country 140968 0
Australia
Phone 140968 0
+61 401008874
Fax 140968 0
Email 140968 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.