The Family Foundations Trial

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.

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 i Покажи пълното описание...

Inclusion Criteria: * Family must be living in a regional or rural area * Family must have at least one child aged 0-12 years * At least 2 parents/caregivers in the family must agree to participate in evaluation, and FF, if allocated. (Please note: A family member or someone else involved in raising children in the family may participate in FF. Families are not required to be in a couple relationship or living together). * At least one parent/caregiver within the family reports mental health difficulties and/or two or more risk factors for poor mental health in the last 5 years including (a) experienced a recent or past natural disaster (i.e., drought, flood, fire, severe storm), (b) living with the threat of a natural disaster (i.e., bushfires during summer), (c) self-reported history of poor mental health, (d) financial hardship, (e) young parental age at time of first baby (18-25yrs), (f) relationship conflict, or (g) social isolation. Exclusion Criteria: * At least one parent has a severe mental health disorder - self reported psychosis, substance use dependency, prescribed anti-psychotic medication that may interfere with their ability to take part in the trial and in the FF intervention if allocated. They may require more intensive mental health interventions and treatment than what can be provided by the trial interventions. * The family has an overt indicator of family violence - self-reported intervention order or court case for family violence. * The family has child protection service involvement - self-reported.