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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT07126379
Registration number
NCT07126379
Ethics application status
Date submitted
8/08/2025
Date registered
17/08/2025
Date last updated
17/08/2025
Titles & IDs
Public title
The Family Foundations Trial
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Scientific title
The Family Foundations Trial: Promoting Family Wellbeing in Regional and Rural Communities Affected by Environmental Threats
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Secondary ID [1]
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117878
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Mental Health Outcomes
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
BEHAVIORAL - Family Foundations
BEHAVIORAL - Family Life Check-In
Experimental: Family Foundations - Families allocated to FF will receive the program via one of the trial satellite sites within 2 weeks of randomisation.
Active comparator: Family Life Check In - 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 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).
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Intervention code [1]
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BEHAVIORAL
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Mental Health Difficulties. The Depression Anxiety Stress Scale-21 (DASS-21), mean difference in total scale scores between FF and Usual Care arms
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Assessment method [1]
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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.
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Timepoint [1]
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24-weeks post-randomisation
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Secondary outcome [1]
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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
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Assessment method [1]
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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.
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Timepoint [1]
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12-weeks post-randomisation
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Secondary outcome [2]
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Mental Health Difficulties. The Depression Anxiety Stress Scale-21 (DASS-21), mean difference in subscale scores between FF and Usual Care arms
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Assessment method [2]
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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.
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Timepoint [2]
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24-weeks post-randomisation
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Secondary outcome [3]
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Kessler Psychological Distress Scale - 6, mean difference in total score between the Family Foundations and Usual Care arms.
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Assessment method [3]
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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.
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Timepoint [3]
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12-weeks post-randomisation
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Secondary outcome [4]
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Kessler Psychological Distress Scale- 6, mean difference in total score between the Family Foundations and Usual Care arms.
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Assessment method [4]
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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.
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Timepoint [4]
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24-weeks post-randomisation
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Secondary outcome [5]
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Parental conflict. The Communication and Problem Solving Scale, mean difference in subscale scores between the Family Foundations and the Usual Care arms.
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Assessment method [5]
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The Communication and Problem Solving Scale consists of 35 items and asks parents about a broad range of behaviours (e.g., 'talk it out with one another; change the subject; threaten to end the relationship) when having a disagreement with their co-parent. Items are rated on a 4-point scale from 1 = Never to 4 = Often. There are six subscales assessing Cooperation, Avoidance, Child Involvement, Stalemating, Verbal Aggression and Physical Aggression. Subscale and total scale scores can be computed with higher scores indicating more frequent engagement in conflict behaviours. The scale has established reliability and validity, and has been used in evaluations of FF in Australia.
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Timepoint [5]
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12 weeks post-randomisation
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Secondary outcome [6]
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Parental conflict. The Communication and Problem Solving Scale , mean difference in subscale scores between the Family Foundations and the Usual Care arms.
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Assessment method [6]
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The Communication and Problem Solving Scale consists of 35 items and asks parents about a broad range of behaviours (e.g., 'talk it out with one another; change the subject; threaten to end the relationship) when having a disagreement with their co-parent. Items are rated on a 4-point scale from 1 = Never to 4 = Often. There are six subscales assessing Cooperation, Avoidance, Child Involvement, Stalemating, Verbal Aggression and Physical Aggression. Subscale and total scale scores can be computed with higher scores indicating more frequent engagement in conflict behaviours. The scale has established reliability and validity, and has been used in evaluations of FF in Australia.
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Timepoint [6]
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24 weeks post-randomisation
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Secondary outcome [7]
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Co-parenting. The Coparenting Relationship Scale, mean difference in subscale scores between FF and the brief intervention arms.
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Assessment method [7]
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The Coparenting Relationship Scale consists of 35 items (e.g., my co-parent asks my opinion on issues related to parenting, my co-parent has lots of patience with our child, my relationship with my co-parent is stronger now than before we had a child), comprising seven subscales (Coparenting Agreement, Coparenting Closesness, Exposure to Conflict, Coparenting Support, Coparenting Undermining, Endorse Co-parent Parenting, and Division of Labor). Each item is rated on a 7-point scale, ranging from 0=Not true of us/Never to 6=Very true of us/Often. Particular items are reverse scored, and then summed. The scale is ideal for examining the role of coparenting in diverse family contexts. The subscales have excellent internal reliability with parent populations in the US and Australia.
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Timepoint [7]
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12-weeks post randomisation
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Secondary outcome [8]
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Co-parenting. The Coparenting Relationship Scale, mean difference in subscale scores between FF and the brief intervention arms.
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Assessment method [8]
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The Coparenting Relationship Scale consists of 35 items (e.g., my co-parent asks my opinion on issues related to parenting, my co-parent has lots of patience with our child, my relationship with my co-parent is stronger now than before we had a child), comprising seven subscales (Coparenting Agreement, Coparenting Closesness, Exposure to Conflict, Coparenting Support, Coparenting Undermining, Endorse Co-parent Parenting, and Division of Labor). Each item is rated on a 7-point scale, ranging from 0=Not true of us/Never to 6=Very true of us/Often. Particular items are reverse scored, and then summed. The scale is ideal for examining the role of coparenting in diverse family contexts. The subscales have excellent internal reliability with parent populations in the US and Australia.
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Timepoint [8]
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24-weeks post randomisation
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Secondary outcome [9]
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Anger. Dimensions of Anger Reactions (DAR-5), The mean difference in DAR-5 between FF and brief intervention arms.
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Assessment method [9]
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The Dimension of Anger Reactions (DAR-5) is a 5-item self- measure of experiences of anger which assesses the frequency, intensity, duration, aggression and impact on a person's social functioning over the past 4-weeks. Items are rated on a 5-point scale, ranging from 1 = None or almost none of the time to 5 = All or almost all of the time, where higher scores indicate worse symptomology, and a score greater than 12 indicated problem anger.
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Timepoint [9]
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24-weeks post randomisation
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Secondary outcome [10]
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Wellbeing. Warwick Edinburgh Mental Wellbeing Scale Short form (SWEMWBS), mean difference in wellbeing between the FF and brief intervention arms.
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Assessment method [10]
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To focus on the positive aspects of mental health, the Warwick Edinburgh Mental Wellbeing Scale Short form (SWEMWBS) will be used to assess thoughts and feelings which relate to mental wellbeing. The 7-items assessing a range of positive thoughts and experiences related to mental health (e.g., I have been feeling optimistic about the future; I've been dealing with problems well; I have been thinking clearly) in the last 2 weeks on a 5-point scale from 1 = None of the time to 5 = All of the time. Items scores were summed, with higher scores indicating higher overall wellbeing.
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Timepoint [10]
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12-weeks post randomisation
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Secondary outcome [11]
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Wellbeing. Warwick Edinburgh Mental Wellbeing Scale Short form (SWEMWBS), mean difference in wellbeing between the FF and brief intervention arms.
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Assessment method [11]
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To focus on the positive aspects of mental health, the Warwick Edinburgh Mental Wellbeing Scale Short form (SWEMWBS) will be used to assess thoughts and feelings which relate to mental wellbeing. The 7-items assessing a range of positive thoughts and experiences related to mental health (e.g., I have been feeling optimistic about the future; I've been dealing with problems well; I have been thinking clearly) in the last 2 weeks on a 5-point scale from 1 = None of the time to 5 = All of the time. Items scores were summed, with higher scores indicating higher overall wellbeing.
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Timepoint [11]
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24-weeks post randomisation
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Secondary outcome [12]
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Child-Parent Relationship. Child-Parent Relationship Scale-short form (CPRS), mean difference in the conflict and closeness subscale scores between the FF and brief intervention arms.
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Assessment method [12]
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The Child-Parent Relationship Scale- short form (CPRS) assesses parents' perceptions of their relationship with their child. The scale consists of 15-items that assess parents' perceptions of their relationship with their child (e.g., 'I share an affectionate, warm relationship with my child'). Items were rated on a 5-point scale ranging from 1= definitely does not apply to 5 = definitely applies. There are two subscales assessing (1) Closeness and (2) Conflict. Item scores were summed with higher scores indicating higher closeness or conflict in the parent-child relationship.
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Timepoint [12]
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24-weeks post randomisation
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Secondary outcome [13]
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Parenting hostility. The Brief Co-parental Communication Scale , The mean difference in parenting hostility scores between the FF and brief intervention arms.
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Assessment method [13]
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The brief Co-parental Communication Scale used in the Longitudinal Study of Australian Children which consists of five items assessing how often parents engage in verbal conflict (e.g. 'How often do you argue?') and one item assessing how often they engage in physical conflict (e.g. 'How often do you have arguments with your co-parent that end up with people pushing, hitting, kicking or shoving?'). The items are rated on a 5-point scale from 1 = never to 5 = always. Items scores were summed, with higher scores indicating more frequent interparental conflict. The scale has excellent reliability and validity in Australian populations.
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Timepoint [13]
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24-weeks post randomisation
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Secondary outcome [14]
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Quality of life. The Assessment of Quality of Life 8 dimension (AQoL-8D), mean difference in quality of life subscales scores between the FF and brief intervention arms.
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Assessment method [14]
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The Assessment of Quality of Life 8 dimension (AQoL-8D). It is a validated tool assessing quality of life impacts in the economic evaluation. Australian population normative data are available and will be used to determine preference weighted health related quality of life utility scores ranging from 0-1 with higher scores indicating higher quality of life. The AQoL-8D is particularly suited to measuring mental health aspects of quality of life. Participants will complete the scale via an online REDCap survey.
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Timepoint [14]
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24-weeks post randomisation
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Secondary outcome [15]
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Traumatic Stress Symptoms. The Brief PTSD Checklist, the difference in proportion of participants meeting the clinical cut off between the FF and usual care will be assessed.
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Assessment method [15]
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The brief version of the PTSD Checklist is a self-report 4-item screening tool for the presence of trauma symptoms in the last 4 weeks. The measures asks participants to rate the extent to which they have experienced four diagnostic symptoms of PTSD in the past month. Participants are asked to rate the extent that they are bothered by a traumatic event on a 5 point scale (0 = not at all to 4 = Extremely).
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Timepoint [15]
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24-weeks post randomisation
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Secondary outcome [16]
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Suicidal Ideation. The Suicidal Ideation Attributes Scale (SIAS), risk difference between FF and the brief intervention arms.
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Assessment method [16]
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Suicidal ideation will be assessed using the Suicidal Ideation Attributes Scale (SIAS). The SIAS is a self-reported 5-item screening tool for the presence and severity of suicidal thoughts in the last month based on frequency, controllability, closeness to attempt, level of distress, and impact on daily functioning. Any ideation is indicative of risk for suicidal behaviour (scores \>1 indicate risk).
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Timepoint [16]
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12-weeks post randomisation
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Secondary outcome [17]
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Suicidal Ideation. The Suicidal Ideation Attributes Scale (SIAS), risk difference between FF and the brief intervention arms.
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Assessment method [17]
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Suicidal ideation will be assessed using the Suicidal Ideation Attributes Scale (SIAS). The SIAS is a self-reported 5-item screening tool for the presence and severity of suicidal thoughts in the last month based on frequency, controllability, closeness to attempt, level of distress, and impact on daily functioning. Any ideation is indicative of risk for suicidal behaviour (scores \>1 indicate risk).
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Timepoint [17]
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24-weeks post randomisation
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Secondary outcome [18]
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Suicidal Ideation. The Suicidal Ideation Attributes Scale (SIAS), mean difference in total scale score between FF and the brief intervention arms.
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Assessment method [18]
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Suicidal ideation will be assessed using the Suicidal Ideation Attributes Scale (SIAS). The SIAS is a self-reported 5-item screening tool for the presence and severity of suicidal thoughts in the last month based on frequency, controllability, closeness to attempt, level of distress, and impact on daily functioning. Any ideation is indicative of risk for suicidal behaviour (scores \>1 indicate risk).
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Timepoint [18]
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12-weeks post randomisation
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Secondary outcome [19]
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Suicidal Ideation. The Suicidal Ideation Attributes Scale (SIAS), mean difference in total scale score between FF and the brief intervention arms.
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Assessment method [19]
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Suicidal ideation will be assessed using the Suicidal Ideation Attributes Scale (SIAS). The SIAS is a self-reported 5-item screening tool for the presence and severity of suicidal thoughts in the last month based on frequency, controllability, closeness to attempt, level of distress, and impact on daily functioning. Any ideation is indicative of risk for suicidal behaviour (scores \>1 indicate risk).
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Timepoint [19]
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24-weeks post randomisation
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Secondary outcome [20]
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Health Service Use cost, mean difference in cost of healthcare use between the FF and Usual Care arms
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Assessment method [20]
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Health dervice use will be assessed by self-reported type and costof healthcare services accessed (prior to baseline and during the study period).
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Timepoint [20]
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24-Weeks post randomisation
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Secondary outcome [21]
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Health Service Use, mean difference in number of healthcare use between the FF and Usual Care arms
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Assessment method [21]
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Health dervice use will be assessed by self-reported type and number healthcare services accessed (prior to baseline and during the study period).
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Timepoint [21]
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24-Weeks post randomisation
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Secondary outcome [22]
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Productivity. The Work Productivity and Activity Impairment Questionnaire: General Health (WPAI), mean difference in total scores between the FF and Usual Care arms
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Assessment method [22]
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the Work Productivity and Activity Impairment Questionnaire: General Health (WPAI) which is a measure of impairments in both paid and unpaid work. Participants are asked 6-items (e.g., are you currently employed, hours missed due to a health problem, hours worked and degree health has affected productivity while at work on a Visual Analogue Scale) for the past seven days. It is well validated among specific health problems and between clinical treatment groups.
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Timepoint [22]
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24-weeks post randomisation
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
1/10/2025
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/08/2027
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Actual
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Sample size
Target
472
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Deakin University - Burwood
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Recruitment hospital [2]
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Colac Area Health - Colac
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Recruitment hospital [3]
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Holstep Health - Melbourne
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Recruitment hospital [4]
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The Bridge Youth Service - Shepparton
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Recruitment hospital [5]
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Kids First - Wallan
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Recruitment hospital [6]
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Brophy Family & Youth Services - Warrnambool
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Recruitment postcode(s) [1]
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3125 - Burwood
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Recruitment postcode(s) [2]
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3250 - Colac
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Recruitment postcode(s) [3]
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3058 - Melbourne
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Recruitment postcode(s) [4]
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3632 - Shepparton
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Recruitment postcode(s) [5]
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3756 - Wallan
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Recruitment postcode(s) [6]
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3280 - Warrnambool
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Funding & Sponsors
Primary sponsor type
Other
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Name
Deakin University
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Address
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Other collaborator category [1]
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Other
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Name [1]
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La Trobe University
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Other collaborator category [2]
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Other
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Name [2]
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Holstep Health
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Address [2]
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0
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Other collaborator category [3]
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Other
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Name [3]
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Colac Area Health
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Other collaborator category [4]
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Other
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Name [4]
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Brophy Family & Youth Service
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Other collaborator category [5]
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Other
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Name [5]
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The Bridge
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Other collaborator category [6]
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Other
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Name [6]
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Kids First
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Address [6]
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Other collaborator category [7]
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Other
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Name [7]
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Murdoch Childrens Research Institute
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Address [7]
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Country [7]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT07126379
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Rebecca Giallo
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Address
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Deakin University
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Rebecca L Giallo, PhD
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Address
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Country
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Phone
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+61431101643
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
We will not seek consent from participants to share their data, and we do not have ethics approval to share individual participant data.
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT07126379
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