Determining the Effectiveness of Working Out Dads to Reduce Mental Health Difficulties in Fathers of Young Children
NCT ID: NCT04813042
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
NA
293 participants
INTERVENTIONAL
2021-06-24
2026-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
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.
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Working Out Dads
Fathers allocated to the Working Out Dads (WOD) arm will receive the intervention program. WOD is a 6-week manualised program. The weekly 90 minute sessions combine a one hour facilitated discussion by a male facilitator trained in delivery of WOD and a 30-minute gym workout provided by a personal trainer. The group size ranges from 6-10 fathers, with 14 groups running over the study period. The weekly sessions are provided in the evenings, in local gyms or a community setting (e.g., maternal child health centre, local council rooms, local hall, local park, Tweddle Child \& Family Health Service).
Working Out Dads
The WOD is a manualised group intervention underpinned by solution-focused therapy and social cognitive theories. Psychoeducation about the transition to fatherhood and its potential impacts on wellbeing and family relationships is provided. Fathers are encouraged to share practical ideas for managing stress, revisit previous strategies, validate what they are doing well, and explore solutions.
The group discussion is followed by a structured group fitness session provided by a personal trainer. This session focuses on body weight exercises, cardio-based activities, stretching, mobility and incidental activity.
Fathers in the WOD study arm receive 10 weeks of encouraging text messages - one each week during the intervention, and four in the weeks after. These will be sent via the WhatsApp group created for each WOD group. These text messages and the WhatsApp group are designed to facilitate fathers' active engagement with the intervention, and to maintain contact with each other.
Usual Care
Fathers allocated to the Usual Care arm will receive the clinical care typically provided to parents experiencing mental health difficulties by an Early Parenting Centre or community health service. Within 2 weeks of baseline assessment, Usual Care participants will receive a brief psychological consultation from Tweddle's Clinical Manager.
Usual care
The Usual Care arm, also known as 'Talking about being dad' comprises a telephone consultation with a qualified mental health professional. Topics including in this consultation include: (a) discuss family and fathering; (b) health and wellbeing; (c) mental health symptoms and conduct a risk assessment for suicidal ideation; (d) current supports and support needs; (e) provide referral options to telephone support services (PANDA; MensLine); and (f) encourage a general practitioner visit to discuss a mental health care plan.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Working Out Dads
The WOD is a manualised group intervention underpinned by solution-focused therapy and social cognitive theories. Psychoeducation about the transition to fatherhood and its potential impacts on wellbeing and family relationships is provided. Fathers are encouraged to share practical ideas for managing stress, revisit previous strategies, validate what they are doing well, and explore solutions.
The group discussion is followed by a structured group fitness session provided by a personal trainer. This session focuses on body weight exercises, cardio-based activities, stretching, mobility and incidental activity.
Fathers in the WOD study arm receive 10 weeks of encouraging text messages - one each week during the intervention, and four in the weeks after. These will be sent via the WhatsApp group created for each WOD group. These text messages and the WhatsApp group are designed to facilitate fathers' active engagement with the intervention, and to maintain contact with each other.
Usual care
The Usual Care arm, also known as 'Talking about being dad' comprises a telephone consultation with a qualified mental health professional. Topics including in this consultation include: (a) discuss family and fathering; (b) health and wellbeing; (c) mental health symptoms and conduct a risk assessment for suicidal ideation; (d) current supports and support needs; (e) provide referral options to telephone support services (PANDA; MensLine); and (f) encourage a general practitioner visit to discuss a mental health care plan.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 an overt indicator of family violence - self-reported intervention order or court case for family violence
* Has child protection service involvement
18 Years
MALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Melbourne
OTHER
Tweddle Child and Family Health Service
UNKNOWN
Australian National University
OTHER
La Trobe University
OTHER
Swinburne University of Technology
OTHER
Deakin University
OTHER
Murdoch Childrens Research Institute
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Rebecca Giallo, PhD
Role: PRINCIPAL_INVESTIGATOR
Murdoch Childrens Research Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Murdoch Children's Research Institute
Parkville, Victoria, Australia
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Giallo R, Seymour M, Fogarty A, Hosking C, Williams LA, Cooklin A, Grobler A, Ride J, Leach L, Oldenburg B, Wood C, Borschmann R, O'Brien J, Evans K, Treyvaud K, Garfield C, Brown S, Nicholson J. Working out dads (WOD): a study protocol for a randomised controlled trial of a group-based peer support intervention for men experiencing mental health difficulties in early fatherhood. BMC Psychiatry. 2022 Feb 12;22(1):111. doi: 10.1186/s12888-022-03698-5.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
69411
Identifier Type: -
Identifier Source: org_study_id