The Family Foundations Trial
NCT07126379 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 472
Last updated 2025-08-17
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.
Conditions
- Mental Health Outcomes
Interventions
- 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).
Sponsors & Collaborators
-
La Trobe University
collaborator OTHER -
Holstep Health
collaborator UNKNOWN -
Colac Area Health
collaborator UNKNOWN -
Brophy Family & Youth Service
collaborator UNKNOWN -
The Bridge
collaborator UNKNOWN -
Kids First
collaborator UNKNOWN -
Murdoch Childrens Research Institute
collaborator OTHER -
Deakin University
lead OTHER
Principal Investigators
-
Rebecca Giallo · Deakin University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-10-01
- Primary Completion
- 2027-07-01
- Completion
- 2027-08-01
Countries
- Australia
Study Locations
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