The Working Out Dads (WOD) Trial: Comparing the Effectiveness of a Group Peer-Support Intervention (WOD) With Usual Care in Reducing the Mental Health Difficulties of Fathers of Young Children
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 293
- 试验地点
- 2
- 主要终点
- Kessler Psychological Distress Scale, mean difference in total scale scores between the Working Out Dads and Usual Care arms
研究概览
简要总结
This is an individually randomised trial, where Working Out Dads (WOD) will be delivered as a group intervention. Participants will be randomised to one of two groups: either WOD or usual care.The trial aims to test the effectiveness and cost-effectiveness of WOD, a 6-week week group-based peer support intervention, in reducing fathers' mental health difficulties in early parenthood.
详细描述
This is an individually randomised trial, where Working Out Dads (WOD) will be delivered as a group intervention.
The primary aim of this study is to test the effectiveness and cost-effectiveness of WOD in reducing fathers' mental health difficulties in early parenthood. A second aim is to identify barriers and facilitators for sustained use and scalability of the WOD program and its adaptation across Victoria and Australia in the future.
Participants will be 280 fathers of young children (0-4 years) who are experiencing mental health difficulties or at risk of poor mental health and suicide. Approximately 140 fathers will be randomised to WOD, and 140 fathers randomised to usual care.
Fathers will be recruited from four Victorian Local Government Areas (LGAs): Wyndham, Whittlesea, Geelong, and Ballarat. Within these sites, fathers will be recruited through maternal and child health, medical and family support services.
Data will be collected via self-report surveys at baseline, 10 weeks, 24 weeks, 18 months, and 3 years. The assessment at 24 weeks will also include a telephone interview with a researcher (blinded) to assess mental health. In August 2022, an optional 72-week follow-up was added to the study design.
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
盲法说明
Treatment allocation will be concealed prior to randomisation by the use of a web-based randomisation system. A statistician not directly involved in the analysis of the trial results will prepare the randomisation schedule using permuted block randomisation, stratified by LGA, using a random number generator on a computer. The schedule will be held by the independent statistician and embedded within the web-based data management system.
Treatment allocation will only be revealed after it has been confirmed that the participant is eligible and enrolled and has completed the baseline questionnaire. REDCap will display the father's assignment for the Project Coordinator, who will notify the father of his treatment assignment and intervention/usual care information by telephone. The treatment allocation in the database will only be visible to the Project Coordinator.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Be aged 18 years or older
- •Be biological or step-father, or male caregiver of a child aged 0-4 years
- •Be in regular weekly contact with the child, even if non-resident parent
- •Be sufficiently fluent in English to complete surveys and participate in the intervention
- •Have mental health difficulties above the symptomatic cut-point (score of 20+) on the K
- •Have at least two risk factors for poor mental health/suicide including: (a) history of mental health difficulties; (b) relationship difficulties; (c) high work-related stress; (d) unemployment; or (e) have a child with sleep difficulties, a disability, chronic illness or other special health care need.
排除标准
- •Has a severe mental health disorder - self reported psychosis, substance use dependency, prescribed anti-psychotic medication that may require more intensive mental health interventions and treatment
- •Has an overt indicator of family violence - self-reported intervention order or court case for family violence
- •Has child protection service involvement
结局指标
主要结局
Kessler Psychological Distress Scale, mean difference in total scale scores between the Working Out Dads and Usual Care arms
时间窗: post intervention at week 24
The 10-item Kessler Psychological Distress Scale (K10) assesses depressive and anxiety symptoms in the last 4 weeks. Scores range from 10-50 with higher scores indicating greater levels of psychological distress. Rationale: The K10 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.
次要结局
- The Kessler Psychological Distress Scale mean difference in total scale scores between the Working Out Dads and Usual Care arms(post intervention at week 72)
- Me as a Parent Scale mean difference in total scale scores between the Working Out Dads and Usual Care arms.(post intervention at week 72)
- The Depression Anxiety Stress Scale-21 mean difference scale scores between the Working Out Dads and Usual Care arms(post intervention at week 72)
- The Suicidal Ideation Attributes Scale mean difference in total scale scores between the Working Out Dads and Usual Care arms(post intervention at week 72)
- The Medical Outcomes Study-Social Support Survey mean difference in total scale scores between the Working Out Dads and Usual Care arms(post intervention at week 72)
- Perceived Need for Care Questionnaire (modified version), mean difference in proportion with unmet need between the Working Out Dads and Usual Care arms(post intervention at week 72)
- The Child-Parent Relationship Scale- short form mean difference in total scale scores between the Working Out Dads and Usual Care arms(post intervention at week 24)
- Health Service Use, mean difference in number of healthcare use between the Working Out Dads and Usual Care arms(post intervention at week 72)
- Parenting Warmth, hostility and engagement in home learning activities- mean difference in total summed scores between the Working Out Dads and Usual Care arms.(post intervention at week 72)
- Uptake of father specific supports and/or activities- mean difference in number of activities taken up between the Working Out Dads and Usual Care arms.(post intervention at week 72)
- The Mini International Neuropsychiatric Interview mean difference in proportion of depressive, suicidal, and anxiety mental health disorders between Working Out Dads and Usual Care arms(post intervention at week 24)
- The Depression Anxiety Stress Scale-21mean difference scale scores between Working Out Dads and Usual Care arms(post intervention at week 10)
- The Depression Anxiety Stress Scale-21 mean difference scale scores between the Working Out Dads and Usual Care arms(post intervention at 156 weeks (3 years))
- The Suicidal Ideation Attributes Scale mean difference in total scale scores between the Working Out Dads and Usual Care arms(post intervention at week 156 (3 years))
- The Medical Outcomes Study-Social Support Survey mean difference in total scale scores between the Working Out Dads and Usual Care arms(post intervention at week 156 (3 years))
- Perceived Need for Care Questionnaire (modified version), mean difference in proportion with unmet need between the Working Out Dads and Usual Care arms(post intervention at week 156 (3 years))
- The Revised Attitudes Towards Seeking Professional Psychological Help Scale mean difference in total scale scores between the Working Out Dads and Usual Care arms(post intervention at week 24)
- The Karitane Parenting Confidence Scale mean difference in total scale scores between the Working Out Dads and Usual Care arms(post intervention at week 24)
- The Child-Parent Relationship Scale- short form mean difference in total scale scores between the Working Out Dads and Usual Care arms(post intervention at week 156 (3 years))
- Health Service Use cost, mean difference in cost of healthcare use between the Working Out Dads and Usual Care arms(post intervention at week 24)
- Health Service Use, mean difference in number of healthcare use between the Working Out Dads and Usual Care arms(post intervention at week 156 (3 years))
- The Assessment of Quality of Life 8 dimension, mean difference in preference weighted health related quality of life utility scores between the Working Out Dads and Usual Care arms(post intervention at week 72)
- The Kessler Psychological Distress Scale mean difference in total scale scores between the Working Out Dads and Usual Care arms(post intervention at week 156 (3 years))
- Health behaviours mean differences in summed scores between the Working Out Dads and Usual Care arms(post intervention at week 72)
- Me as a Parent Scale mean difference in total scale scores between the Working Out Dads and Usual Care arms.(post intervention at week 156 (3 years))
- Child-Parent Relationhip Scale mean difference in total scale scores between the Working Out Dads and Usual Care arms.(post intervention at week 72)
- Parenting Warmth, hostility and engagement in home learning activities- mean difference in total summed scores between the Working Out Dads and Usual Care arms.(post intervention at week 156 (3 years))
- Uptake of father specific supports and/or activities- mean difference in number of activities taken up between the Working Out Dads and Usual Care arms.(post intervention at week 156 (3 years))
- Perceived burdensomeness and thwarted belongingness difference in mean item response scores between the Working Out Dads and Usual Care arms.(post intervention at week156 (3 years))
- professional help-seeking attitudes- mean difference in total scale scores between the Working Out Dads and Usual Care arms(post intervention at week 24 weeks)
- Co-parenting. The Coparenting Relationship Scale, mean difference in subscale scores between WODand the Usual careintervention arms.(156 - weeks post randomisation - (3 years))
- Total difficulticulties mean difference in total scores between the Working Out Dads and Usual Care arms(post intervention at week 156 (3 years))
- Interparental conflict. mean difference in total scale scores on the Co-parental Communication Scale between the Working Out Dads and Usual Care arms(post intervention at week 156 (3 years))
- Work to family conflict mean difference in total scores across 4 adapted items between the Working Out Dads and Usual Care arms(post intervention at week 156 (3 years))
- positive health behaviours mean difference in total scores between the Working Out Dads and Usual Care arms(post intervention at week 156 (3 years))
- Difference in occurance of self-harm ideation or behaviour between the Working Out Dads and Usual Care arms(post intervention at week 156 (3 years))
- Difference in occurance of lietime suicide attempt between the Working Out Dads and Usual Care arms(post intervention at week 156 (3 years))