NCT07126379

The Family Foundations Trial

The Family Foundations Trial: Promoting Family Wellbeing in Regional and Rural Communities Affected by Environmental Threats

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 472 (estimated)
• Sponsor: Deakin University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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: 1. Reach and uptake of FF by rural families 2. Experiences of care for families receiving FF or the brief intervention 3. Intervention fidelity 4. Enablers and barriers to implementation and adoption (not covered in this protocol) 5. Workforce knowledge, skills, and confidence to provide mental health care to families (not covered in this protocol) 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: 1. Assessment of family needs with one or more parents 2. Referral to local services, including a GP to discuss a mental health care plan 3. Provision of reputable Australian web-based resources (e.g., Raising Children Network, Phoenix Disaster Recovery) 4. Referral to telephone/online support services (e.g., Beyond Blue, Lifeline, PANDA, MensLine, Kids Helpline, Parentline) 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.

Conditions

• Mental Health Outcomes

Interventions

Type	Name	Description
BEHAVIORAL	Family Foundations	FF is an 8-session program for families of children aged 0-12 years targeting parent mental health and family conflict. It will be delivered via telehealth by an allied health professional (i.e., social work, psychology, counselling qualification) trained in FF. The 8 sessions can be delivered flexibly (1 or 2 sessions per week). The duration between sessions can vary as per the needs of the family. We are allowing up to 11 weeks from randomisation for FF to be completed. FF is a manualised program which provides instruction on discussion activities, skills practice, video and workbook exercises for every session. Sessions are based around the content areas of: emotion regulation, stress management, healthy communication, coparenting, conflict resolution, and problem solving.
BEHAVIORAL	Family Life Check-In	Families allocated to Family Life Check In will receive this condition from a Clinical Research Nurse, employed at the Primary site (deakin University) with 2 weeks of randomisation. This brief intervention will be comparable to care typically provided to parents/caregivers seeking support for mental health difficulties and/or family/parent relationships issues from a community health service at intake. Family Life Check-In involves a brief (\~30 minute) telephone consultation involving: a) an assessment of the families' needs with one or all parents, b) referral to local services including GP to discuss a mental health care plan, c) provision of reputable Australian web-based resources about supporting children during crises (Raising Children Network, Phoenix Disaster Recovery), and (d) telephone and online support services (BeyondBlue; Lifeline, PANDA, MensLine, KidsLine, Parentline).

Timeline

• Start date: 2025-10-01
• Primary completion: 2027-07-01
• Completion: 2027-08-01
• First posted: 2025-08-17
• Last updated: 2025-08-17

Locations

6 sites across 1 country: Australia