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Trial registered on ANZCTR


Registration number
ACTRN12620000154909
Ethics application status
Approved
Date submitted
16/12/2019
Date registered
13/02/2020
Date last updated
13/02/2020
Date data sharing statement initially provided
13/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The Healthier Wealthier Families (HWF) pilot randomised trial: offering financial support through community health services.
Scientific title
The Healthier Wealthier Families (HWF) pilot randomised trial: offering financial support through community health services.
Secondary ID [1] 299493 0
Nil known
Universal Trial Number (UTN)
Trial acronym
HWF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood inequity 314728 0
Health service research 314729 0
Poverty 314730 0
Deprivation 316099 0
Parent mental health 316100 0
Condition category
Condition code
Public Health 313062 313062 0 0
Health service research
Public Health 313063 313063 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is referral to financial counselling by Maternal and Child Health (MCH) nurses (also known as Child and Family Health (CFH) nurses). In Australia, financial counselling is free. It is administered by an independent and accredited financial counsellor in the non-government community sector. The intervention uses a client-centred approach to determine the frequency, duration, mode of delivery and activities delivered. An independent interpreter service may assist participants who prefer to use a language other than English.

Financial counselling activities are intended to improve a participant’s financial situation, and may include (but are not limited to) goal and priority-setting; explaining options and consequences of financial decisions; checking eligibility for government assistance; application for hardship variation; debt negotiation with creditors; assistance with planning finances and budgets; and referral to other health and social services. Participants have as many visits or contacts with the financial counsellor as needed.

At 3- and 6-months post-enrolment, financial counsellors will be asked to complete a questionnaire asking about goals initially set; frequency of participant contact and compliance; specific activities and advice delivered; and known changes in participant financial status.

At 3- and 6-months post-enrolment, participants will be asked to complete a questionnaire to assess the primary and secondary outcomes.
Intervention code [1] 316289 0
Treatment: Other
Comparator / control treatment
The comparator is usual care, plus information from an independent and government-funded money advice website “MoneySmart”. MoneySmart is a free resource that provides objective, plain-language advice developed by financial counselling on a comprehensive range of debt, budgetary management and financial literacy topics; some resources are specific to Aboriginal and Torres Strait Islander people, and selected MoneySmart resources are available in 26 languages. MoneySmart outlines methods and contact details for further financial, legal and crisis support; this includes the National Debt Helpline, a free hotline which links callers to a local free financial counselling service. MoneySmart is commonly used by financial counsellors to advise clients.

At 3- and 6-months post-enrolment, participants will be asked to complete a questionnaire to assess the primary and secondary outcomes.
Control group
Active

Outcomes
Primary outcome [1] 322238 0
Feasibility:
• Number/proportion of clients who agree to complete screening survey with MCH/CFH nurse in relation to service usage statistics [MCH/CFH nurse report, MCH/CFH service records].
• Number/proportion of eligible clients who consent to participate [MCH/CFH nurse report].
• Number/proportion of intervention participants who access, attend and complete the financial counselling intervention [financial counsellor and participant report].
• Number/proportion of participants who complete 6-month follow-up assessment [research completion records].
Timepoint [1] 322238 0
3- and 6-months post-enrolment.
Secondary outcome [1] 377834 0
Intervention impact - Household income and sources of income
• Questions adapted from the Household, Income and Labour Dynamics in Australia (HILDA) Survey and Longitudinal Study of Australian Children (LSAC)
Timepoint [1] 377834 0
3- and 6-months post-enrolment
Secondary outcome [2] 379524 0
Intervention impact - Type of loans
• Questions adapted from the Household, Income and Labour Dynamics in Australia (HILDA) Survey and Longitudinal Study of Australian Children (LSAC)
Timepoint [2] 379524 0
3- and 6-month post-enrolment
Secondary outcome [3] 379525 0
Intervention impact - Meeting household costs
• Questions adapted from the Household, Income and Labour Dynamics in Australia (HILDA) Survey, Australian Research Alliance for Children and Youth Nest Survey, and Community Understanding of Poverty and Social Exclusion (CUPSE) Survey
Timepoint [3] 379525 0
3- and 6-months post-enrolment
Secondary outcome [4] 379526 0
Intervention impact - Parent general health
• General Health Questionnaire 1 (GHQ1)
Timepoint [4] 379526 0
3- and 6-months post-enrolment
Secondary outcome [5] 379527 0
Intervention impact - Parent mental health
• Depression, Anxiety, Stress Scale short-form (DASS-21)
Timepoint [5] 379527 0
3- and 6-months post-enrolment
Secondary outcome [6] 379528 0
Intervention impact - Parenting efficacy
• From the Longitudinal Study of Australian Children (LSAC)
Timepoint [6] 379528 0
3- and 6-months post-enrolment
Secondary outcome [7] 380067 0
Intervention impact - Service use (including use of financial supports; study-designed questions)
Timepoint [7] 380067 0
3- and 6-months post-enrolment

Eligibility
Key inclusion criteria
• The parent or carer of a young child (defined by the maternal and child health (MCH)/child and family health (CFH) nursing service as birth to age 5 years);
• A client of the participating MCH/CFH service.
• Lives inside the geographical boundaries serviced by the participating financial counselling service.
• Provides a signed and dated informed consent form.
• Reports at least one risk factor for financial hardship, as screened by MCH/CFH nurse.

Note, parents of any age are eligible, hence the young minimum age specified.
Minimum age
10 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Does not comprehend the recruitment invitation.
• Already enrolled and assigned a research participant ID.
• Has no mechanism for contact (telephone or email).
• Already an active client in a financial counselling service.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be performed using a computer program. The randomisation schedule will be securely stored by the randomisation program and concealed by a statistician engaged by the research study for this purpose.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A statistician will prepare the randomisation schedule using block randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size: We aim to enrol and randomise 60 participants (30 per arm). As this is a feasibility pilot, the sample size is not designed to provide sufficient power to detect between-groups differences in impact measures (i.e. efficacy). Therefore, we are not performing a sample size calculation, nor estimating a treatment effect. Rather, this pilot will help inform the sample size required for a larger efficacy or effectiveness trial.

Quantitative data analysis: Baseline characteristics of participating families will be described for each group. Impact measures will similarly be described by treatment arm and comparisons made using the t-test and non-parametric tests for continuous data and the chi-squared test for categorical data. If suitable (e.g. where the model allows), linear and logistic regression modelling will be conducted to test group differences adjusting for basic baseline characteristics identified a priori. A subgroup analysis will describe the participants identified as Priority 1 who are not included as RCT participants but do continue as research participants.

Qualitative data analysis: qualitative interviews with a subsample of participants, nurses and financial counsellors, will be audio-recorded and transcribed, and subsequently coded.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 28786 0
3757 - Whittlesea
Recruitment postcode(s) [2] 28787 0
3083 - Bundoora
Recruitment postcode(s) [3] 28788 0
3754 - Doreen
Recruitment postcode(s) [4] 28789 0
3076 - Epping
Recruitment postcode(s) [5] 28790 0
3754 - Mernda
Recruitment postcode(s) [6] 28791 0
3082 - Mill Park
Recruitment postcode(s) [7] 28792 0
3752 - South Morang
Recruitment postcode(s) [8] 28793 0
3074 - Thomastown
Recruitment postcode(s) [9] 28794 0
3750 - Wollert
Recruitment postcode(s) [10] 28868 0
3757 - Eden Park
Recruitment postcode(s) [11] 28870 0
3757 - Kinglake West
Recruitment postcode(s) [12] 28871 0
3757 - Humevale
Recruitment postcode(s) [13] 28872 0
3753 - Beveridge
Recruitment postcode(s) [14] 28873 0
3755 - Yan Yean
Recruitment postcode(s) [15] 28874 0
3064 - Donnybrook
Recruitment postcode(s) [16] 28875 0
3075 - Lalor
Recruitment postcode(s) [17] 28876 0
3751 - Woodstock

Funding & Sponsors
Funding source category [1] 303989 0
Charities/Societies/Foundations
Name [1] 303989 0
Helen Macpherson Smith Trust
Address [1] 303989 0
27 Windsor Place,
Melbourne, Victoria 3000.
Country [1] 303989 0
Australia
Funding source category [2] 304502 0
Charities/Societies/Foundations
Name [2] 304502 0
Murdoch Children's Research Institute
Address [2] 304502 0
48-50 Flemington Road,
Parkville Victoria 3052.
Country [2] 304502 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Murdoch Children's Research Institute
Address
48-50 Flemington Road,
Parkville Victoria 3052.
Country
Australia
Secondary sponsor category [1] 304770 0
None
Name [1] 304770 0
Address [1] 304770 0
Country [1] 304770 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304486 0
Royal Children's Hospital
Ethics committee address [1] 304486 0
48-50 Flemington Road,
Parkville 3052, Victoria.
Ethics committee country [1] 304486 0
Australia
Date submitted for ethics approval [1] 304486 0
10/09/2019
Approval date [1] 304486 0
06/12/2019
Ethics approval number [1] 304486 0
HREC/57372/RCHM-2019

Summary
Brief summary
Financial hardship can have a major deleterious impact on the health and wellbeing of children and their families. In Australia, 1 in 6 children live in poverty, and one quarter experience deprivation (such as missing out on proper nutrition, housing and supportive personal relationships) due to financial hardship. Government aims to provide social care and support services to protect families from financial hardship; however, many families miss out.

This pilot study aims to test the feasibility and short-term impact of financial counselling offered to families experiencing or at-risk of financial hardship, by systematising referral pathways between the free, universal Maternal and Child Health Service/Child and Family Health Nursing Service and a free, community-based financial counselling service.
Trial website
Trial related presentations / publications
Public notes
1. The Primary outcome (Feasibility) will not be assessed using a between-groups comparison of the RCT.

2. Participants identified as being high-risk for high impact consequences (e.g. bankruptcy, loss of housing or essential service utilities, termed 'Priority 1') will not be randomised. This group will be referred directly with indicated priority to the financial counselling service. For those who consent, we will continue to collect research data to inform the feasibility of the study (primary outcome), but their data will not be part of the RCT (between-groups) analyses.

3. We will use an ongoing process review following quality improvement principles to monitor feasibility from the start of the study. This means the study procedures may be modified (following approval from the governing HREC/s) to optimise feasibility.

4. We are working with collaborators to develop a replica pilot study in NSW.

Contacts
Principal investigator
Name 97114 0
Dr Anna Price
Address 97114 0
Centre for Community Child Health,
Royal Children's Hospital,
48-50 Flemington Road,
Parkville, Victoria 3052.
Country 97114 0
Australia
Phone 97114 0
+61 3 9936 6613
Fax 97114 0
Email 97114 0
hwf.study@mcri.edu.au
Contact person for public queries
Name 97115 0
Ms Natalie Schreurs
Address 97115 0
Centre for Community Child Health,
Royal Children's Hospital,
48-50 Flemington Road,
Parkville, Victoria 3052.
Country 97115 0
Australia
Phone 97115 0
+61 3 9936 6286
Fax 97115 0
Email 97115 0
hwf.study@mcri.edu.au
Contact person for scientific queries
Name 97116 0
Ms Natalie Schreurs
Address 97116 0
Centre for Community Child Health,
Royal Children's Hospital,
48-50 Flemington Road,
Parkville, Victoria 3052.
Country 97116 0
Australia
Phone 97116 0
+61 3 9936 6286
Fax 97116 0
Email 97116 0
hwf.study@mcri.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Decided on a case-by-case basis at the discretion of the Investigator team and consistent with Ethics approval.
When will data be available (start and end dates)?
After publication and available for at least 15 years after data collection, or indefinitely for participants who consent to having their research information stored for future use.
Available to whom?
Decided on a case-by-case basis at the discretion of the Investigator team and consistent with Ethics approval.
Available for what types of analyses?
Decided on a case-by-case basis at the discretion of the Investigator team and consistent with Ethics approval.
How or where can data be obtained?
Subject to approval by the Investigator team and Ethical and Legal departments. By emailing the study team at hwf.study@mcri.edu.au.
What supporting documents are/will be available?
No other documents available
Summary results
No Results