Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12625001337460
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
27/10/2025
Date registered
Help: Date registered
1/12/2025
Date last updated
Help: Date last updated
14/10/2026
Date data sharing statement initially provided
Help: Data sharing statement date
1/12/2025
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Healthier Wealthier Families (HWF) trial: supporting families with young children through financial counselling referrals embedded into well-child healthcare home visits.
Scientific title
Study protocol for the Healthier Wealthier Families (HWF) cluster randomised controlled trial: testing the effectiveness and cost-benefits of offering financial counselling to families with young children who report financial hardship at well-child healthcare home visits.
Additional trial identifiers [1] 315623 0
None
Universal Trial Number (UTN)
Trial acronym
HWF
Related trial records
This study is following on from the pilot study ACTRN12620000154909.

Health condition
Health condition(s) studied:
Childhood inequity 339290 0
Caregiver Mental health 339539 0
Condition category
Condition code
Public Health 335552 335552 0 0
Health service research
Mental Health 336114 336114 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Intervention:
Healthier Wealthier Families (HWF) connects well-child health visits with community-based financial counselling to provide an early intervention for financial hardship for families with young children. This protocol describes a pragmatic cluster randomised controlled trial (RCT) of the HWF model embedded in well-child home visits in the Australian state of Queensland. The home visiting model that HWF is being embedded in is known as the Maternal Early Childhood Sustained Home-visiting (MECSH) Program.

The HWF intervention comprises 3 components:
(1) MECSH providers screen all clients for financial hardship in surveys during routine well-child home visiting program.
(2) MECSH clients (usually the biological mother) who are experiencing financial hardship, will be offered a referral by the MECSH provider to financial counselling.
(3) MECSH clients who agree to a referral will be contacted directly by phone by the financial counselling service. In Australia, financial counselling is a specialised profession that requires accreditation with a state-based peak body, a supervised training period, and ongoing professional development (e.g. trauma-informed care, responding to family violence). Financial counsellors work on a client’s behalf and are not mandated to report client activities to government. Clients have as many appointments with a financial counsellor as they need to achieve their goals.

Recruitment and procedure:
MECSH providers collect routine data on demographics, occasions of service and caregiver-reported outcomes, and support clients to complete implementation surveys at enrolment (pregnancy to 8 weeks postpartum), 6 and 22-23 months postpartum. When HWF commences in a service area, HWF financial hardship screening items are embedded within routine MECSH surveys for all clients according to cluster allocation. Additional HWF-specific surveys are conducted at approximately 12 and 18 months postpartum, or at the MECSH provider’s discretion if a client is experiencing financial hardship and a referral is being considered. All routine MECSH and HWF surveys include the Matthey General Mood Questionnaire (MGMQ, see measures) to assess caregiver mental health.

Outcome data for the trial will be collected approximately 13–24 months after allocation and will comprise follow-up data for Group 1 (‘now’) participants and initial screening data for Group 2 (‘next’) participants. Where required, participants who have ceased engagement with MECSH may be contacted by text message or telephone to collect primary outcome data.

For clients who report financial hardship, the MECSH provider describes the financial counselling service and asks whether the caregiver agrees to the HWF referral. Recording a client’s agreement within the MECSH database automatically sends a referral email to the financial counsellor provider's intake team, who contact the client and do a standard intake assessment. Following referral, caregivers are invited to consent to sharing relevant data with MCRI for the purposes of evaluating HWF. These referral and consent processes are informed by the feasibility pilot, where all referred clients consented to data sharing.
Intervention code [1] 332244 0
Early detection / Screening
Intervention code [2] 332415 0
Prevention
Intervention code [3] 332416 0
Treatment: Other
Description of the comparator or control
The comparator is the usual MECSH service delivery model. MECSH offers 25 home visits (60-90 minutes) with the same specially trained nurse or health practitioner (termed ‘MECSH provider’ throughout) from pregnancy until children turn 2-3 years old, and at least one visit with a social care practitioner. MECSH is designed to develop the parenting capacity that underpins children’s learning and development.

After cluster allocation, Group 1 ('now') participants receive MECSH usual service and HWF. For the first 12 months after cluster allocation, participants in Group 2 ('next') receive the standard MECSH service without HWF. Twelve months after allocation, both groups ('now' and 'next') receive MECSH and HWF.
Control group
Active

Outcomes
Primary outcome [1] 343094 0
Material deprivation.
Timepoint [1] 343094 0
Outcome data will be collected 13-24 months after randomisation, and comprise the follow-up financial and mental health data for Group 1 clients, and the initial survey data for Group 2 clients.
Secondary outcome [1] 453382 0
Adapt and Self Manage total score.
Timepoint [1] 453382 0
Outcome data will be collected 13-24 months after randomisation, and comprise the follow-up financial and mental health data for Group 1 clients, and the initial survey data for Group 2 clients.
Secondary outcome [2] 453383 0
Enablement.
Timepoint [2] 453383 0
Outcome data will be collected 13-24 months after randomisation, and comprise the follow-up financial and mental health data for Group 1 clients, and the initial survey data for Group 2 clients.
Secondary outcome [3] 453384 0
Satisfaction.
Timepoint [3] 453384 0
Outcome data will be collected 13-24 months after randomisation, and comprise the follow-up financial and mental health data for Group 1 clients, and the initial survey data for Group 2 clients.
Secondary outcome [4] 469242 0
Caregiver Mental Health
Timepoint [4] 469242 0
Outcome data will be collected 13-24 months after randomisation and comprise the follow-up financial and mental health data for Group 1 clients, and the initial survey data for Group 2 clients.

Eligibility
Key inclusion criteria
Potential participants will be all MECSH clients in participating HWF regions.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Not enrolled in the MECSH program; not living within participating HWF regions.

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 concealment until after central randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated block randomisation of service area clusters.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The design is a pragmatic cluster RCT with twenty-four MECSH service areas (clusters) randomised 1:1 to immediate ("now") or delayed ("next") implementation of financial hardship screening. Group 1 receives screening for the first 12 months after allocation. Group 2 receives screening commencing 12 months after allocation. Outcome comparisons are conducted using data collected 13–24 months after allocation. This design is different to a delayed or withheld intervention because clients are not screened for financial hardship until the point that financial counselling can be offered. Using data collected during the second 12 months, the primary aim will compare the initial nurse-collected material deprivation and mental health data for Group 2 with the follow-up material deprivation and mental health data for Group 1.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Intention to Treat principle will be followed including all randomised clusters and all eligible participants. Baseline characteristics and outcomes will be described by group. A mixed effects logistic regression, adjusted for baseline characteristics identified a priori, such as mental health and sociodemographic characteristics (as fixed effects) will be fitted with financial hardship and poor mental health outcome variables. The randomised treatment groups will be a fixed effect, and randomised cluster will be a random effect to account for the clustering within MECSH service areas. Marginalised probabilities will be used to calculate risk differences. Risk differences and 95% confidence intervals will be estimated using marginalised probabilities. Multiple imputation will be used if more than 10% of outcome data are missing and data are considered missing at random. Supplementary analyses will assess material deprivation as a count outcome using mixed-effect Poisson regression.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2027
Actual
Date of last participant enrolment
Anticipated
2/07/2029
Actual
Date of last data collection
Anticipated
31/07/2029
Actual
Sample size
Target
336
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 320223 0
Charities/Societies/Foundations
Name [1] 320223 0
Paul Ramsay Foundation
Country [1] 320223 0
Australia
Funding source category [2] 320224 0
Charities/Societies/Foundations
Name [2] 320224 0
Ian Potter Foundation
Country [2] 320224 0
Australia
Funding source category [3] 323230 0
Government body
Name [3] 323230 0
NHMRC
Country [3] 323230 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Murdoch Children's Research Institute
Address
Country
Australia
Secondary sponsor category [1] 322790 0
None
Name [1] 322790 0
Address [1] 322790 0
Country [1] 322790 0
Other collaborator category [1] 283718 0
Government body
Name [1] 283718 0
Queensland Health
Address [1] 283718 0
Country [1] 283718 0
Australia
Other collaborator category [2] 283719 0
Charities/Societies/Foundations
Name [2] 283719 0
UnitingCare Queensland
Address [2] 283719 0
Country [2] 283719 0
Australia
Other collaborator category [3] 283720 0
University
Name [3] 283720 0
Western Sydney University
Address [3] 283720 0
Country [3] 283720 0
Australia
Other collaborator category [4] 283721 0
University
Name [4] 283721 0
Deakin University
Address [4] 283721 0
Country [4] 283721 0
Australia
Other collaborator category [5] 283722 0
Charities/Societies/Foundations
Name [5] 283722 0
Financial Counselling Australia
Address [5] 283722 0
Country [5] 283722 0
Australia
Other collaborator category [6] 283723 0
University
Name [6] 283723 0
University of Melbourne
Address [6] 283723 0
Country [6] 283723 0
Australia
Other collaborator category [7] 283724 0
Charities/Societies/Foundations
Name [7] 283724 0
Australian Research Alliance for Children and Youth (ARACY)
Address [7] 283724 0
Country [7] 283724 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318765 0
UnitingCare Health Human Research Ethics Committee
Ethics committee address [1] 318765 0
Ethics committee country [1] 318765 0
Australia
Date submitted for ethics approval [1] 318765 0
30/08/2025
Approval date [1] 318765 0
18/11/2025
Ethics approval number [1] 318765 0
202504

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

Contacts
Principal investigator
Name 145194 0
Dr Anna Price
Address 145194 0
Centre for Community Child Health, Murdoch Children's Research Institute, Royal Children's Hospital, Flemington Road, Parkville 3052, Victoria Australia.
Country 145194 0
Australia
Phone 145194 0
+6138341 6200
Fax 145194 0
Email 145194 0
[email protected]
Contact person for public queries
Name 145195 0
Anna Price
Address 145195 0
Centre for Community Child Health, Murdoch Children's Research Institute, Royal Children's Hospital, Flemington Road, Parkville 3052, Victoria Australia.
Country 145195 0
Australia
Phone 145195 0
+6138341 6200
Fax 145195 0
Email 145195 0
[email protected]
Contact person for scientific queries
Name 145196 0
Anna Price
Address 145196 0
Centre for Community Child Health, Murdoch Children's Research Institute, Royal Children's Hospital, Flemington Road, Parkville 3052, Victoria Australia.
Country 145196 0
Australia
Phone 145196 0
+6138341 6200
Fax 145196 0
Email 145196 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
At the end of the study
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Data sharing request system: For data held by MCRI, researchers are invited to request access, including individual participant data and a data dictionary defining each field, from the Melbourne Children’s Campus LifeCourse institutional data access platform (https://lifecourse.melbournechildrens.com/data-access/).

Are there extra considerations when requesting access to individual participant data?
Yes: Different data will held by different partners, who will have different data sharing provisions.



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.