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In this project, researchers are exploring different ways to support the wellbeing and relationships of families with young children (0-12 years). People in regional and rural communities often live with the threat of bushfires, floods, drought, severe storms, and other extreme weather events. Some families have been affected by these disasters and are still trying to recover.
Researchers will test two different ways of supporting families in regional and rural Victoria:
Family Foundations (FF): An 8-session program to promote parent wellbeing, parenting partnerships, and communication. All parents/caregivers/parenting partners in the family participate in sessions delivered by a health professional online.
Family Life Check-In: A brief 30-minute telephone call with a health professional to discuss family wellbeing and relationships, and identify any supports needed.
The goal of this trial is to learn whether FF works to reduce mental health difficulties for regional and rural families. The main question it aims to answer is:
Compared to Family Life Check-In, does Family Foundations lead to fewer mental health difficulties?
Participants will:
Complete an online survey before randomisation, after they have received FF or Family Life Check-In, and six months after starting the project.
Take part in either Family Foundations or Family Life Check-In.
Full description
Study Design This is a parallel-group, multi-site, randomised controlled trial. Family Foundations (FF), an 8-session family-based intervention, will be compared to a brief intervention (single brief telephone consultation plus resources and referral). FF will be delivered via telehealth from five rural health service sites. Families (comprised of at least two parents/caregivers) will be randomised in a 1:1 ratio to the two treatment arms. The trial is open-label.
This trial will be registered within the Australian Teletrial Program. A teletrial is a group of clinical satellite sites working together to conduct a clinical trial, consisting of a Primary Site (Deakin University, which assumes overall responsibility for the conduct of the trial) and five satellite sites that will deliver the FF intervention. These sites are: Holstep Health, Kids First, Colac Area Health, The Bridge Youth Service, and Brophy Family and Youth Service.
Study Aims
There are two main aims of this study:
Aim 1: To evaluate the effectiveness of FF in reducing mental health difficulties for rural families.
We hypothesise that, compared to a brief intervention (single telephone consultation plus resources and referral), FF will lead to fewer parent mental health difficulties (primary outcome at 24 weeks post-randomisation).
Aim 2: To assess the implementation of FF and the brief intervention, including:
Participants Participants will be 236 families (at least 472 parents/caregivers) of children aged 0-12 years, living in regional or rural areas of Australia. At least two parents/caregivers in each family must agree to participate, as this is a family intervention, but they are not required to be in a couple relationship or living together.
Recruitment Families living in regional and rural areas will be invited to participate in a study about ways to promote and protect the wellbeing of families in country Australia, particularly those currently or recently (within the past five years) experiencing environmental threats (e.g., drought, floods, severe storms, bushfires).
Study promotion and recruitment will occur across a range of settings, including the general public, community services, and through our partners (Royal Flying Doctor Service - Victoria; National Centre for Farmer Health). Recruitment strategies, co-designed with our partners and lived-experience group, will include a mix of active and passive approaches.
Intervention Arms The FF program (intervention) will be compared to the brief intervention (control), referred to as Family Life Check-In. This name will be used consistently in all study materials and in the PICF.
Families allocated to FF will receive the program via one of the trial satellite sites within two weeks of randomisation. Satellite sites will indicate their capacity to deliver FF to allocated families regardless of the family's location.
FF is an 8-session, manualised program for families of children aged 0-12 years, targeting parent mental health and family conflict. It is delivered via telehealth by allied health professionals (e.g., social workers, psychologists, or counsellors) trained in FF. Sessions may be delivered flexibly (1-2 per week), with up to 11 weeks allowed from randomisation to completion. Each session includes discussion activities, skills practice, videos, and workbook exercises. Content areas include emotion regulation, stress management, healthy communication, co-parenting, conflict resolution, and problem-solving.
Families allocated to the brief intervention will receive support from a Clinical Research Nurse employed at the primary site (Deakin University), who is a qualified maternal and child health nurse with experience supporting parents and families. Within two weeks of randomisation, the nurse will conduct a brief (~30-minute) telephone consultation that includes:
Data Collection
Participants will complete online self-report surveys at three time points:
Baseline (~2 weeks prior to randomisation)
12 weeks after randomisation
24 weeks after randomisation
Participants will also be invited to a qualitative interview at 24 weeks. Details of the outcome measures are provided in the uploaded study protocol and the 'Outcome Measures' section of this form.
Data Analysis A detailed statistical analysis plan will be prepared by Dr Anneke Grobler before database lock. Analyses will follow the intention-to-treat (ITT) principle. Continuous endpoints (primary and secondary outcomes) will be analysed using linear regression, adjusting for treatment arm, health service site, and baseline scores. Clustering at the family level will be accounted for using appropriate statistical models.
Mean differences between treatment arms will be reported with 95% confidence intervals. Risk differences will be calculated using a generalised linear model (GLM) with an identity link function and binomial family, including treatment arm, health service site, and baseline scores. Standard errors will be clustered at the family level.
Health Economic Analysis Health economic analysis will be led by Professor Suzanne Robinson at Deakin University. A cost-consequences analysis will present the incremental cost of the intervention (intervention plus service use) minus control group costs, alongside all outcome measures. A cost-effectiveness analysis will estimate the incremental cost per: Unit reduction in distress score (K6 or DASS-21); QALY gained (via AQoL-8D).Results will be reported in line with CHEERS guidelines. A modelled estimate of costs and cost-effectiveness for scale-up will be developed in collaboration with service partners, based on current capacity and anticipated need. Sensitivity analyses will assess the robustness of findings.
Dissemination and Translation Plan Findings will be reported to the Medical Research Future Fund: Million Minds Mission (MRFF) through progress and final reports. Results will also be disseminated via conference presentations and at least two peer-reviewed publications. Only aggregated, de-identified group data will be reported.
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472 participants in 2 patient groups
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Central trial contact
Rebecca L Giallo, PhD; Alison Fogarty
Data sourced from clinicaltrials.gov
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