Clinical trial NCT04813042: Determining the Effectiveness of Working Out Dads to Reduce Mental Health Difficulties in Fathers of Young Children
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mental Health Issue
Keywords: mental health
fathers
men
early fatherhood
peer group intervention
Lead sponsor: Murdoch Childrens Research Institute
Sponsor class: OTHER
Collaborators: name: University of Melbourne
name: Tweddle Child and Family Health Service
name: Australian National University
name: La Trobe University
name: Swinburne University of Technology
name: Deakin University
First posted: 2021-03-24
Enrollment: 293
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: TREATMENT

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.

Detailed description: 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, and 24 weeks. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Kessler Psychological Distress Scale, mean difference in total scale scores between the Working Out Dads and Usual Care arms
timeFrame: post intervention at week 24
Secondary outcomes:
measure: 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
timeFrame: post intervention at week 24
measure: The Depression Anxiety Stress Scale-21mean difference scale scores between Working Out Dads and Usual Care arms
timeFrame: post intervention at week 10
measure: The Depression Anxiety Stress Scale-21 mean difference scale scores between the Working Out Dads and Usual Care arms
timeFrame: post intervention at week 24
measure: The Depression Anxiety Stress Scale-21 mean difference scale scores between the Working Out Dads and Usual Care arms
timeFrame: post intervention at week 72
measure: The Suicidal Ideation Attributes Scale mean difference in total scale scores between the Working Out Dads and Usual Care arms
timeFrame: post intervention at week 10
measure: The Suicidal Ideation Attributes Scale mean difference in total scale scores between the Working Out Dads and Usual Care arms
timeFrame: post intervention at week 24
measure: The Suicidal Ideation Attributes Scale mean difference in total scale scores between the Working Out Dads and Usual Care arms
timeFrame: post intervention at week 72
measure: The Medical Outcomes Study-Social Support Survey mean difference in total scale scores between the Working Out Dads and Usual Care arms
timeFrame: post intervention at week 24
measure: The Medical Outcomes Study-Social Support Survey mean difference in total scale scores between the Working Out Dads and Usual Care arms
timeFrame: post intervention at week 10
measure: The Medical Outcomes Study-Social Support Survey mean difference in total scale scores between the Working Out Dads and Usual Care arms
timeFrame: post intervention at week 72
measure: Perceived Need for Care Questionnaire (modified version), mean difference in proportion with unmet need between the Working Out Dads and Usual Care arms
timeFrame: post intervention at week 24
measure: Perceived Need for Care Questionnaire (modified version), mean difference in proportion with unmet need between the Working Out Dads and Usual Care arms
timeFrame: post intervention at week 72
measure: The Revised Attitudes Towards Seeking Professional Psychological Help Scale mean difference in total scale scores between the Working Out Dads and Usual Care arms
timeFrame: post intervention at week 24
measure: The Karitane Parenting Confidence Scale mean difference in total scale scores between the Working Out Dads and Usual Care arms
timeFrame: post intervention at week 24
measure: The Child-Parent Relationship Scale- short form mean difference in total scale scores between the Working Out Dads and Usual Care arms
timeFrame: post intervention at week 24
measure: Health Service Use cost, mean difference in cost of healthcare use between the Working Out Dads and Usual Care arms
timeFrame: post intervention at week 24
measure: Health Service Use, mean difference in number of healthcare use between the Working Out Dads and Usual Care arms
timeFrame: post intervention at week 24
measure: Health Service Use, mean difference in number of healthcare use between the Working Out Dads and Usual Care arms
timeFrame: post intervention at week 72
measure: 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
timeFrame: post intervention at week 24
measure: 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
timeFrame: post intervention at week 72
measure: The Kessler Psychological Distress Scale mean difference in total scale scores between the Working Out Dads and Usual Care arms
timeFrame: post intervention at week 10
measure: The Kessler Psychological Distress Scale mean difference in total scale scores between the Working Out Dads and Usual Care arms
timeFrame: post intervention at week 72
measure: Health behaviours mean differences in summed scores between the Working Out Dads and Usual Care arms
timeFrame: post intervention at week 72
measure: Me as a Parent Scale mean difference in total scale scores between the Working Out Dads and Usual Care arms.
timeFrame: post intervention at week 72
measure: Child-Parent Relationhip Scale mean difference in total scale scores between the Working Out Dads and Usual Care arms.
timeFrame: post intervention at week 72
measure: Parenting Warmth, hostility and engagement in home learning activities- mean difference in total summed scores between the Working Out Dads and Usual Care arms.
timeFrame: post intervention at week 72
measure: 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.
timeFrame: post intervention at week 72
Other outcomes:
Locations:
city: Parkville
country: Australia
facility: Murdoch Children's Research Institute
state: Victoria
Study officials:
affiliation: Murdoch Childrens Research Institute
name: Rebecca Giallo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.