The Family Foundations Trial: Promoting Family Wellbeing in Regional and Rural Communities Affected by Environmental Threats
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 472
- 试验地点
- 12
- 主要终点
- Mental Health Difficulties. The Depression Anxiety Stress Scale-21 (DASS-21), mean difference in total scale scores between FF and Usual Care arms
研究概览
简要总结
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.
详细描述
Study Design This is a parallel-group, multi-site, randomised controlled trial. Family Foundations (FF), an 8-session family-based intervention, will be compared to a brief intervention (single brief telephone consultation plus resources and referral). FF will be delivered via telehealth from five 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 University, which assumes overall responsibility for the conduct of the trial) and five satellite sites that will deliver the FF intervention. These sites are: Holstep Health, Kids First, Colac Area Health, The Bridge Youth Service, and Brophy Family and Youth Service.
Study Aims
There are two main aims of this study:
Aim 1: To evaluate the effectiveness of FF in reducing mental health difficulties for rural families.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Mental Health Difficulties. The Depression Anxiety Stress Scale-21 (DASS-21), mean difference in total scale scores between FF and Usual Care arms
时间窗: 24-weeks post-randomisation
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.
次要结局
- 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.(24-weeks post-randomisation)
- Anger. Dimensions of Anger Reactions (DAR-5), The mean difference in DAR-5 between FF and brief intervention arms.(24-weeks post randomisation)
- 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.(24-weeks post randomisation)
- 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.(24-weeks post randomisation)
- Health Service Use cost, mean difference in cost of healthcare use between the FF and Usual Care arms(24-Weeks post randomisation)
- Productivity. The Work Productivity and Activity Impairment Questionnaire: General Health (WPAI), mean difference in total scores between the FF and Usual Care arms(24-weeks post randomisation)
- 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)
- 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)
- Parental conflict. The Communication and Problem Solving Scale , mean difference in subscale scores between the Family Foundations and the Usual Care arms.(24 weeks post-randomisation)
- Co-parenting. The Coparenting Relationship Scale, mean difference in subscale scores between FF and the brief intervention arms.(24-weeks post randomisation)
- Wellbeing. Warwick Edinburgh Mental Wellbeing Scale Short form (SWEMWBS), mean difference in wellbeing between the FF and brief intervention arms.(24-weeks post randomisation)
- Health Service Use, mean difference in number of healthcare use between the 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)
- Parenting hostility. The Brief Co-parental Communication Scale , The mean difference in parenting hostility scores between the FF and brief intervention arms.(24-weeks post randomisation)
- 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.(24-weeks post randomisation)
- Suicidal Ideation. The Suicidal Ideation Attributes Scale (SIAS), risk difference between FF and the brief intervention arms.(24-weeks post randomisation)
- Suicidal Ideation. The Suicidal Ideation Attributes Scale (SIAS), mean difference in total scale score between FF and the brief intervention arms.(24-weeks post randomisation)