Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001363875
Ethics application status
Approved
Date submitted
15/07/2021
Date registered
8/10/2021
Date last updated
8/10/2021
Date data sharing statement initially provided
8/10/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
An evaluation of MacKillop Family Services’ Family Preservation and Reunification Response for vulnerable families
Scientific title
MacKillop Family Services’ Family Preservation and Reunification Response for vulnerable families - A protocol for an effectiveness-implementation study
Secondary ID [1] 304781 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Family violence 322853 0
Out-of-home care placement 322854 0
Condition category
Condition code
Mental Health 320432 320432 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Family Preservation and Reunification (FPR) Response:
The FPR Response is a family service program that aims to provide intensive support to families where the child(ren) is/are at significant risk of being removed and placed in out-of-home care (i.e., alternative care placement when it is unsafe for the child to remain in the care of their parent/s), or to enable the reunification of removed children in a timely manner. The family's key practitioner engages with the family intensively over a period of six months, defined as a home visit for at least one hour, three times a week. Practitioners implement evidence-informed methods that focus on parenting skills, parent-child attachment and capacity to effectively respond during a crisis. The mode of delivery is variable, depending on each families' needs, but may include cognitive behavioural therapy, family therapy, systemic therapy, and case management. These methods support families to meet their goals and the program's available brokerage funds are used as an enabler as needed. The program is also designed to support families to link into the community and its services to build independence, self-sufficiency, and a social network. Multi-disciplinary teams forged through partnerships with other agencies enhances the direct engagement of families with experts in parenting, drug and alcohol services as well as regional care, to deliver specialised support to families. No physical informational materials will be provided to participants. To monitor adherence, key practitioners will complete regular case notes to document all occasions of contact or attempted contact with the family, mode and type of intervention delivered during each home visit, and which family members were present at each home visit (i.e., at least one parent will be present for every home visit, and children may be included at various stages through program delivery as well, depending on each family's needs and goals). Practitioners will undergo the Multi-Systemic Family Therapy training, Circle of Security training, and Newborn Observation Training delivered by MacKillop Family Services.
Intervention code [1] 321167 0
Prevention
Intervention code [2] 321404 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328274 0
Out-of-home care placement - measured by the number of entries or re-entries into out-of-home care, assessed via document analysis review of FPR practitioners' case notes. This is a composite primary outcome.
Timepoint [1] 328274 0
Program closure (primary timepoint, six months post-intervention commencement) and 12-months post-closure.
Secondary outcome [1] 398313 0
Parenting capacity - this is a composite outcome that will be measured by a composite of the Parent Efficacy and Empowerment Measure and North Carolina Family Assessment Scale.
Timepoint [1] 398313 0
Program intake and closure (six months post-intervention commencement).
Secondary outcome [2] 398314 0
Child development - this is a composite outcome that will be measured by a composite of the North Carolina Family Assessment Scale and Strengths and Difficulties Questionnaire.
Timepoint [2] 398314 0
Program intake and closure (six months post-intervention commencement).
Secondary outcome [3] 398315 0
Implementation (encompasses barriers, enablers, fidelity, acceptability and feasibility of program delivery) - qualitative interviews with program staff. Interviews will be one-on-one, semi-structured, and conducted over the phone or via zoom, depending on the personal preference of the participant. All interviews will be audio-recorded with the purpose of transcription.
Timepoint [3] 398315 0
Once every two months throughout the 6-month study period.
Secondary outcome [4] 399486 0
Family safety - measured by the North Carolina Family Assessment Scale
Timepoint [4] 399486 0
Program intake and closure (six months post-intervention commencement).
Secondary outcome [5] 399487 0
Family home environment - measured by the North Carolina Family Assessment Scale
Timepoint [5] 399487 0
Program intake and closure (six months post-intervention commencement).

Eligibility
Key inclusion criteria
Parents living in Victoria, Australia, that are at risk for child removal (child substantiation) or have at least one child already residing in out-of-home care. Child is aged between 0-17 years. Parents will have at least two of the following risk factors placing their child at risk of removal:
- history of out-of-home care themselves
- child or parent identifies as Aboriginal or Torres Strait Islander
- young mother (aged under 20 at birth)
- drug or alcohol concerns
- mental health concerns
- other physical development or health concerns (i.e., chronic illness, intellectual disability)
- family/domestic violence present

Program staff will also be involved in this study. Program staff will be eligible if they have been involved in the delivery of the program for at least one month.
Minimum age
16 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Parents will not be eligible for participation if they:
- do not speak English
- do not reside or work in the relevant catchment areas in Victoria
- are already engaged in another family service programs
- have no child protection involvement

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
2/11/2020
Date of last participant enrolment
Anticipated
3/07/2023
Actual
Date of last data collection
Anticipated
3/02/2025
Actual
Sample size
Target
250
Accrual to date
60
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 309155 0
Commercial sector/Industry
Name [1] 309155 0
MacKillop Family Services
Country [1] 309155 0
Australia
Primary sponsor type
University
Name
Monash University
Address
553 St Kilda Road
Melbourne, VIC, 3004
Country
Australia
Secondary sponsor category [1] 310109 0
None
Name [1] 310109 0
Address [1] 310109 0
Country [1] 310109 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309019 0
Monash University Human Ethics Research Committee
Ethics committee address [1] 309019 0
Ethics committee country [1] 309019 0
Australia
Date submitted for ethics approval [1] 309019 0
Approval date [1] 309019 0
30/10/2020
Ethics approval number [1] 309019 0

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

Contacts
Principal investigator
Name 112666 0
Dr Heather Morris
Address 112666 0
Monash University
553 St Kilda Road
Melbourne, VIC, 3004
Country 112666 0
Australia
Phone 112666 0
+61 407 049 950
Fax 112666 0
Email 112666 0
[email protected]
Contact person for public queries
Name 112667 0
Heather Morris
Address 112667 0
Monash University
553 St Kilda Road
Melbourne, VIC, 3004
Country 112667 0
Australia
Phone 112667 0
+61 407 049 950
Fax 112667 0
Email 112667 0
[email protected]
Contact person for scientific queries
Name 112668 0
Heather Morris
Address 112668 0
Monash University
553 St Kilda Road
Melbourne, VIC, 3004
Country 112668 0
Australia
Phone 112668 0
+61 407 049 950
Fax 112668 0
Email 112668 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.