The Family Foundations Trial

NCT07126379 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 472

Last updated 2025-08-17

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07126379 on ClinicalTrials.gov