Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000940572
Ethics application status
Approved
Date submitted
4/07/2024
Date registered
2/08/2024
Date last updated
2/08/2024
Date data sharing statement initially provided
2/08/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Caring for Caregivers: A Postnatal Wellbeing Program
Scientific title
Caring for Caregivers: Evaluating the Acceptability and Feasibility of Implementation of an Evidence-Informed Program to Support Caregiver Wellbeing in Early Parenting Groups
Secondary ID [1] 312459 0
Nil known
Universal Trial Number (UTN)
U1111-1310-2802
Trial acronym
Linked study record
This study is a trial being conducted in parallel to ACTRN12624000904572.

Health condition
Health condition(s) or problem(s) studied:
Caregiver mental health 334294 0
Caregiver wellbeing 334363 0
Caregiver social support 334364 0
Caregiver self-care 334365 0
Condition category
Condition code
Mental Health 330946 330946 0 0
Other mental health disorders
Public Health 330947 330947 0 0
Health promotion/education
Public Health 330948 330948 0 0
Health service research
Mental Health 330949 330949 0 0
Anxiety
Mental Health 330950 330950 0 0
Depression
Reproductive Health and Childbirth 331010 331010 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Caring for Caregivers Trial is a feasibility proof-of-concept pre- and post-trial evaluating the feasibility, acceptability, and effectiveness of a caregiver wellbeing program delivered by Child and Family Health Services (CaFHS) in South Australia.

The caregiver wellbeing program was codesigned and developed in 2023. This was achieved through undertaking three activities: 1) a service review where we mapped existing services available within CaFHS, 2) focus groups with 25 caregivers who have access CaFHS services and 9 CaFHS service providers, and 3) a scoping review examining 70 evidence-informed programs and interventions that support caregiver wellbeing and self-care. Through triangulating the results of these three activities and working closely with CaFHS leadership, consumer researchers, and the CaFHS consumer advisory committee, we used the Intervention Mapping Methodology to develop a caregiver wellbeing program that is relevant, feasible and evidence-informed that could be implemented by CaFHS.

A maximum of four South Australian CaFHS sites will be selected and randomly allocated to be either a control site, or an intervention site. The caregiver wellbeing program will be implemented into routine Early Parenting Groups delivered at the intervention sites over a 2-month period. CaFHS Early Parenting Groups comprise of 2-hour weekly sessions for 4 weeks. The caregiver wellbeing program will be implemented in week 3 and will replace the usual week 3 content. Weeks 1, 2, and 4 will be delivered by the usual CaFHS facilitator, however, week 3 will be delivered by the CaFHS project manager (a registered nurse and midwife) and all caregivers enrolled into an Early Parenting Group at an intervention site during the study period will receive the evidence-informed caregiver wellbeing program. Early Parenting Groups on average have approximately 10 caregivers.

The caregiver wellbeing program comprises of approximately 2 hours of content that is structured with a powerpoint presentation and focuses primarily on delivering evidence-informed psychoeducation and facilitation group discussions. Overall the program covers 5 objectives. The objectives are:

1. Understanding Mental Health, Parenting and Seeking Support
2. Discussing Norms, Expectations, and Individualised Experience
3. Navigating Relationships and Social Connections
4. Empowering Self-Worth and Self-Care Strategies
5. Providing Support for Accessing Services and Seeking Help

The project manager will monitor fidelity through a project specific fidelity checklist to track if all 5 objectives are achieved in the class. The project manager will also write reflections in a research journal after each class to keep qualitative notes relating to time spent on each objective, observations regarding participant responses to the content, any ad hoc adaptations to content due to participant engagement, etc.

To further understand the feasibility and fidelity of implementation and acceptability of the caregiver wellbeing program, focus groups will be conducted with approximately 10-15 caregivers who received the intervention and 10-15 CaFHS staff involved in implementation. Participants will be selected as the first 15 to opt-in. Focus groups will be with approximately 5-10 participants and will be conducted by the Flinders University research team (lead researcher and research assistants) and the discussion will focus on 1) the impact of the program on mental health and wellbeing, 2) what was liked or disliked about the content, 3) if there are any concerns regarding the content or how it was delivered, 4) if they would like any modifications to the content or how it was delivered. Specifically, staff will additionally be asked 1) how well the content and the delivery integrates into routine services, 2) if there were any challenges to delivery or implementation, and 3) perspectives on whether the program would work in other CaFHS sites.
Intervention code [1] 328965 0
Prevention
Intervention code [2] 328966 0
Lifestyle
Intervention code [3] 328967 0
Behaviour
Comparator / control treatment
All caregivers enrolled into a parenting group at the two control sites will receive usual care content delivered by a CaFHS Nurse. Usual care involves the 4-week Early Parenting Group content that is set out in the internal Early Parenting Group Guide that is used state-wide by CaFHS.
Control group
Active

Outcomes
Primary outcome [1] 338720 0
Determine feasibility to deliver the caregiver wellbeing program within routine care
Timepoint [1] 338720 0
Baseline Pre intervention and Post-intervention approximately 1-2 weeks after program completion
Primary outcome [2] 338721 0
Determine acceptability of the caregiver wellbeing program
Timepoint [2] 338721 0
Pre intervention and Post-intervention approximately 1-2 weeks after program completion
Secondary outcome [1] 437113 0
Mental health
Timepoint [1] 437113 0
Baseline Pre intervention and Post-intervention approximately 1-2 weeks after program completion
Secondary outcome [2] 437629 0
Wellbeing
Timepoint [2] 437629 0
Baseline Pre intervention and Post-intervention approximately 1-2 weeks after program completion
Secondary outcome [3] 437630 0
Social Support
Timepoint [3] 437630 0
Baseline Pre intervention and Post-intervention approximately 1-2 weeks after program completion
Secondary outcome [4] 437631 0
Self-Care
Timepoint [4] 437631 0
Baseline Pre intervention and Post-intervention approximately 1-2 weeks after program completion
Secondary outcome [5] 437632 0
Determine the feasibility of undertaking a definitive trial
Timepoint [5] 437632 0
Post-intervention 1-2 weeks after trial completion

Eligibility
Key inclusion criteria
Caregivers/parents of children enrolled into a CaFHS parenting group at the control or intervention sites, during the study period.
Staff who work at the intervention site or were involved in implementation, during the trial period.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.The intervention and control sites will be randomly selected however content will be delivered by one project manager thus cannot conceal.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
As the primary aim and objective is feasibility, there will be no formal hypothesis testing or inferential statistics.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
23/07/2024
Date of last participant enrolment
Anticipated
14/08/2024
Actual
Date of last data collection
Anticipated
30/09/2024
Actual
Sample size
Target
192
Accrual to date
6
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 316874 0
Other Collaborative groups
Name [1] 316874 0
Health Translation SA (HTSA) Medical Research Future Fund (MRFF) Catalyst Grant Scheme, led by HTSA, supported by the Women's & Children's Hospital Foundation
Country [1] 316874 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Country
Australia
Secondary sponsor category [1] 319118 0
Government body
Name [1] 319118 0
Preventive Health SA
Address [1] 319118 0
Country [1] 319118 0
Australia
Secondary sponsor category [2] 319121 0
Government body
Name [2] 319121 0
Women's and Children's Health Network
Address [2] 319121 0
Country [2] 319121 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315634 0
Women's and Children's Health Network Human Research Ethics Committee
Ethics committee address [1] 315634 0
Ethics committee country [1] 315634 0
Australia
Date submitted for ethics approval [1] 315634 0
22/05/2024
Approval date [1] 315634 0
17/06/2024
Ethics approval number [1] 315634 0
2024/HRE00067

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

Contacts
Principal investigator
Name 135330 0
Dr Sarah Hunter
Address 135330 0
Flinders University Caring Futures Institute, College of Nursing and Health Sciences, Sturt Road, Bedford Park SA 5042 GPO Box 2100 Adelaide SA 5001
Country 135330 0
Australia
Phone 135330 0
+61 08 82013120
Fax 135330 0
Email 135330 0
[email protected]
Contact person for public queries
Name 135331 0
Sarah Hunter
Address 135331 0
Flinders University Caring Futures Institute, College of Nursing and Health Sciences, Sturt Road, Bedford Park SA 5042 GPO Box 2100 Adelaide SA 5001
Country 135331 0
Australia
Phone 135331 0
+61 08 82013120
Fax 135331 0
Email 135331 0
[email protected]
Contact person for scientific queries
Name 135332 0
Sarah Hunter
Address 135332 0
Flinders University Caring Futures Institute, College of Nursing and Health Sciences, Sturt Road, Bedford Park SA 5042 GPO Box 2100 Adelaide SA 5001
Country 135332 0
Australia
Phone 135332 0
+61 08 82013120
Fax 135332 0
Email 135332 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
Permission for sharing of individual data was not obtained in ethics.


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.