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

NCT04813042 | Active Not Recruiting

• 1 other identifier: 69411
• Study Type: interventional
• Target: 293
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mental Health Issue

Keywords

mental health; fathers; men; early fatherhood; peer group intervention

Outcome Measures

Primary Outcomes (1)

• Kessler Psychological Distress Scale, mean difference in total scale scores between the Working Out Dads and Usual Care arms

  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.

  post intervention at week 24

Secondary Outcomes (47)

• 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 week 24

• 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 10

Study Arms (2)

Working Out Dads

EXPERIMENTAL

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).

Behavioral: Working Out Dads

Usual Care

ACTIVE COMPARATOR

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.

Behavioral: Usual care

Interventions

Working Out Dads BEHAVIORAL

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.

Working Out Dads

Usual care BEHAVIORAL

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.

Also known as: Talking about being a Dad

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Murdoch Childrens Research Institute: lead
• University of Melbourne: collaborator
• Tweddle Child and Family Health Service: collaborator
• Australian National University: collaborator
• La Trobe University: collaborator
• Swinburne University of Technology: collaborator
• Deakin University: collaborator

Study Sites (1)

Murdoch Children's Research Institute

Parkville, Victoria, 3052, Australia

Location

Related Publications (1)

• 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.

  PMID: 35151305 DERIVED

MeSH Terms

Conditions

Psychological Well-Being; Multiple Endocrine Neoplasia Type 1

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases

Study Officials

• Rebecca Giallo, PhD

  Murdoch Childrens Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a parallel group randomised controlled trial. The treatment (Working Out Dads 6-week group intervention) will be compared to usual care (brief consultation + resources + referral). Randomisation and analyses will be at the level of the individual participant and adjusted for clustering at the level of the WOD group and Local Government Area (LGA) as a stratification variable. For the primary analysis, the model based mean K10 score in each trial arm will be compared at post-intervention and at the 6-month follow-up (primary outcome).

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: March 24, 2021
• Study Start: June 24, 2021
• Primary Completion: May 31, 2024
• Study Completion (Estimated): November 30, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 6 months after publication of primary outcome
• Access Criteria: (1) Recognised research institute, (2) data access agreement, (3), proposed use approved by Sponsor Investigator and Trial Steering Committee, and (4) proposed use reviewed and accepted by human research ethics committee.

Locations

AU (1)