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Активно (без набиране) Не е приложимо NCT04813042

Determining the Effectiveness of Working Out Dads to Reduce Mental Health Difficulties in Fathers of Young Children

Не е приложима фаза (напр. обсервационно)
Заболявания: Mental Health Issue

Спонсор: Murdoch Childrens Research Institute

Налично на: БГ
Обобщение
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.
Описание
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. Participants will be randomised in a 1:1 ratio to the two treatment arms. 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 arms: Intervention condition - WOD: Fathers will attend a WOD group within approximately two weeks of randomisation and within four weeks of baseline assessment. WOD is a 6-week group-based peer support intervention. WOD's weekly sessions consists of 1-hour group discussion focused on common challenges and risk factors for poor mental health in early fatherhood, followed by a 30-minute group exercise session. Fathers in the WOD intervention condition will also have access to online resources and a father-managed WhatsApp group. Usual care condition: Fathers will receive the clinical care typically provided by an early parenting or community health service to parents experiencing mental health difficulties. Within two weeks of baseline assessment, Tweddle's Clinical Manager will conduct a brief telephone consultation to: (a) enquire about mental health symptoms and conduct a risk assessment for suicidal ideation; (b) provide referral options to telephone support services (e.g., PANDA, MensLine); and (c) encourage visiting a general practitioner to discuss accessing a mental health care plan.
Кой може да участва
Inclusion Criteria: * 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 K10. AND/OR • 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. Exclusion Criteria: * 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
Места на провеждане 1
Австралия (1)
Murdoch Children's Research Institute
Parkville , Victoria
Технически детайли
Статус
Активно (без набиране)
Фаза
Не е приложимо
Вид изследване
INTERVENTIONAL
Пол
Само мъже
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
24.06.2021
Крайна дата
30.11.2026
Регистрационен номер
NCT04813042
Източник
anzctr
Запитване за медицински туризъм

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