The Family Foundations Trial

NCT07126379 | Not Yet Recruiting DMC

• 1 other identifier: 117878
• Study Type: interventional
• Target: 472
• Locations: 1 country
• Sites: 6

Brief 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

Keywords

mental health; parent mental health; coparenting; rural health

Outcome Measures

Primary Outcomes (1)

• Mental Health Difficulties. The Depression Anxiety Stress Scale-21 (DASS-21), mean difference in total scale scores between FF and Usual Care arms

  The Depression Anxiety Stress Scale-21 (DASS-21) assesses symptoms of depression, anxiety, and stress in the past week (21 items). The items are rated on a 4-point scale ranging from 0-Never to 3-Almost Always. A total scale score can be created, as well as specific subscales for depressive, anxiety and stress symptoms. Higher scores indicate greater levels of mental health difficulties. Excellent reliability and validity has been demonstrated in Australian population-based samples. The DASS-21 is routinely used by early parenting services.

  24-weeks post-randomisation

Secondary Outcomes (22)

• Mental Health Difficulties. The Depression Anxiety Stress Scale-21 (DASS-21), mean difference in total scale and subscale scores between FF and Usual Care arms

  12-weeks post-randomisation

• Mental Health Difficulties. The Depression Anxiety Stress Scale-21 (DASS-21), mean difference in subscale scores between FF and Usual Care arms

  24-weeks post-randomisation

• Kessler Psychological Distress Scale - 6, mean difference in total score between the Family Foundations and Usual Care arms.

  12-weeks post-randomisation

• Kessler Psychological Distress Scale- 6, mean difference in total score between the Family Foundations and Usual Care arms.

  24-weeks post-randomisation

• Parental conflict. The Communication and Problem Solving Scale, mean difference in subscale scores between the Family Foundations and the Usual Care arms.

  12 weeks post-randomisation

Study Arms (2)

Family Foundations

EXPERIMENTAL

Families allocated to FF will receive the program via one of the trial satellite sites within 2 weeks of randomisation.

Behavioral: Family Foundations

Family Life Check In

ACTIVE COMPARATOR

Families allocated to the Family Life Check-In will receive this condition from a Clinical Research Nurse, employed through the primary site (Deakin University) within 2 weeks of randomisation.

Behavioral: Family Life Check-In

Interventions

Family Foundations BEHAVIORAL

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.

Family Foundations

Family Life Check-In BEHAVIORAL

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).

Family Life Check In

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Deakin University: lead
• La Trobe University: collaborator
• Holstep Health: collaborator
• Colac Area Health: collaborator
• Brophy Family & Youth Service: collaborator
• The Bridge: collaborator
• Kids First: collaborator
• Murdoch Childrens Research Institute: collaborator

Study Sites (6)

Deakin University

Burwood, Victoria, 3125, Australia

Location

Colac Area Health

Colac, Victoria, 3250, Australia

Location

Holstep Health

Melbourne, Victoria, 3058, Australia

Location

The Bridge Youth Service

Shepparton, Victoria, 3632, Australia

Location

Kids First

Wallan, Victoria, 3756, Australia

Location

Brophy Family & Youth Services

Warrnambool, Victoria, 3280, Australia

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Rebecca Giallo

  Deakin University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca L Giallo, PhD

CONTACT

+61431101643; r.giallo@deakin.edu.au

Alison Fogarty

CONTACT

ali.fogarty@deakin.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a parallel group multi-site randomised controlled trial. FF (8 session family-based intervention) will be compared to a brief intervention (single brief telephone consultation + resources + referral). FF will be delivered via telehealth from 5 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; assuming overall responsibility for the conduct of the trial) and 5 Satellite Sites who will deliver the FF intervention.

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: August 17, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (6)