About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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 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).

Treatment groups

472 Participants

are divided into 2 treatment groups

Group A: Family FoundationsExperimental treatment 1 intervention

Group B: Family Life Check InActive comparator 1 intervention

Trial outcomes

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.

Time frame

24-weeks post-randomisation

Secondary outcomes

1

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

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.

Time frame

12-weeks post-randomisation

2

Mental Health Difficulties. The Depression Anxiety Stress Scale-21 (DASS-21), mean difference in subscale 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). Scores on each scale range from 0-42 with higher scores indicating a greater severity of symptoms. Clinical ranges are available. Excellent reliability and validity has been demonstrated in Australian population-based samples. The DASS-21 is routinely used by early parenting services.

Time frame

24-weeks post-randomisation

3

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

The 6-item Kessler Psychological Distress Scale (K6) assesses general symptoms of depression and anxiety in the last 30 days/4 weeks. The 6 items are rated on a 5-point scale ranging from 0-None of the time to 4-All of the time. Higher scores indicate higher levels of psychological distress. The K6 is widely used in clinical trials for common mental health disorders, and is consistent with a transdiagnostic approach proposing a common set of psychological distress symptoms underlie mood and anxiety disorders . It has well-established symptomatic and clinical cut-points, high specificity (0.96), robust total classification accuracy (0.92) to identify mood and anxiety disorders \[32\], and correlates with validated measures of suicidality \[45\]. Australian population data for men are available using the K6 (e.g. National Survey of Mental Health and Wellbeing, Longitudinal Study of Australian Children). The study investigators have published extensively on fathers' mental health.

Time frame

12-weeks post-randomisation

4

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

The 6-item Kessler Psychological Distress Scale (K6) assesses general symptoms of depression and anxiety in the last 30 days/4 weeks. The 6 items are rated on a 5-point scale ranging from 0-None of the time to 4-All of the time. Higher scores indicate higher levels of psychological distress. The K6 is widely used in clinical trials for common mental health disorders, and is consistent with a transdiagnostic approach proposing a common set of psychological distress symptoms underlie mood and anxiety disorders . It has well-established symptomatic and clinical cut-points, high specificity (0.96), robust total classification accuracy (0.92) to identify mood and anxiety disorders \[32\], and correlates with validated measures of suicidality \[45\]. Australian population data for men are available using the K6 (e.g. National Survey of Mental Health and Wellbeing, Longitudinal Study of Australian Children). The study investigators have published extensively on fathers' mental health.

Time frame

24-weeks post-randomisation

The Family Foundations Trial

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

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