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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04813042




Registration number
NCT04813042
Ethics application status
Date submitted
10/03/2021
Date registered
24/03/2021

Titles & IDs
Public title
Determining the Effectiveness of Working Out Dads to Reduce Mental Health Difficulties in Fathers of Young Children
Scientific 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
Secondary ID [1] 0 0
69411
Universal Trial Number (UTN)
Trial acronym
WOD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental Health Issue 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Working Out Dads
BEHAVIORAL - Usual care

Experimental: 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).

Active comparator: 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.


BEHAVIORAL: 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.

BEHAVIORAL: 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.
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Kessler Psychological Distress Scale, mean difference in total scale scores between the Working Out Dads and Usual Care arms
Timepoint [1] 0 0
post intervention at week 24
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
post intervention at week 24
Secondary outcome [2] 0 0
The Depression Anxiety Stress Scale-21mean difference scale scores between Working Out Dads and Usual Care arms
Timepoint [2] 0 0
post intervention at week 10
Secondary outcome [3] 0 0
The Depression Anxiety Stress Scale-21 mean difference scale scores between the Working Out Dads and Usual Care arms
Timepoint [3] 0 0
post intervention at week 24
Secondary outcome [4] 0 0
The Depression Anxiety Stress Scale-21 mean difference scale scores between the Working Out Dads and Usual Care arms
Timepoint [4] 0 0
post intervention at week 72
Secondary outcome [5] 0 0
The Suicidal Ideation Attributes Scale mean difference in total scale scores between the Working Out Dads and Usual Care arms
Timepoint [5] 0 0
post intervention at week 10
Secondary outcome [6] 0 0
The Suicidal Ideation Attributes Scale mean difference in total scale scores between the Working Out Dads and Usual Care arms
Timepoint [6] 0 0
post intervention at week 24
Secondary outcome [7] 0 0
The Suicidal Ideation Attributes Scale mean difference in total scale scores between the Working Out Dads and Usual Care arms
Timepoint [7] 0 0
post intervention at week 72
Secondary outcome [8] 0 0
The Medical Outcomes Study-Social Support Survey mean difference in total scale scores between the Working Out Dads and Usual Care arms
Timepoint [8] 0 0
post intervention at week 24
Secondary outcome [9] 0 0
The Medical Outcomes Study-Social Support Survey mean difference in total scale scores between the Working Out Dads and Usual Care arms
Timepoint [9] 0 0
post intervention at week 10
Secondary outcome [10] 0 0
The Medical Outcomes Study-Social Support Survey mean difference in total scale scores between the Working Out Dads and Usual Care arms
Timepoint [10] 0 0
post intervention at week 72
Secondary outcome [11] 0 0
Perceived Need for Care Questionnaire (modified version), mean difference in proportion with unmet need between the Working Out Dads and Usual Care arms
Timepoint [11] 0 0
post intervention at week 24
Secondary outcome [12] 0 0
Perceived Need for Care Questionnaire (modified version), mean difference in proportion with unmet need between the Working Out Dads and Usual Care arms
Timepoint [12] 0 0
post intervention at week 72
Secondary outcome [13] 0 0
The Revised Attitudes Towards Seeking Professional Psychological Help Scale mean difference in total scale scores between the Working Out Dads and Usual Care arms
Timepoint [13] 0 0
post intervention at week 24
Secondary outcome [14] 0 0
The Karitane Parenting Confidence Scale mean difference in total scale scores between the Working Out Dads and Usual Care arms
Timepoint [14] 0 0
post intervention at week 24
Secondary outcome [15] 0 0
The Child-Parent Relationship Scale- short form mean difference in total scale scores between the Working Out Dads and Usual Care arms
Timepoint [15] 0 0
post intervention at week 24
Secondary outcome [16] 0 0
Health Service Use cost, mean difference in cost of healthcare use between the Working Out Dads and Usual Care arms
Timepoint [16] 0 0
post intervention at week 24
Secondary outcome [17] 0 0
Health Service Use, mean difference in number of healthcare use between the Working Out Dads and Usual Care arms
Timepoint [17] 0 0
post intervention at week 24
Secondary outcome [18] 0 0
Health Service Use, mean difference in number of healthcare use between the Working Out Dads and Usual Care arms
Timepoint [18] 0 0
post intervention at week 72
Secondary outcome [19] 0 0
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
Timepoint [19] 0 0
post intervention at week 24
Secondary outcome [20] 0 0
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
Timepoint [20] 0 0
post intervention at week 72
Secondary outcome [21] 0 0
The Kessler Psychological Distress Scale mean difference in total scale scores between the Working Out Dads and Usual Care arms
Timepoint [21] 0 0
post intervention at week 10
Secondary outcome [22] 0 0
The Kessler Psychological Distress Scale mean difference in total scale scores between the Working Out Dads and Usual Care arms
Timepoint [22] 0 0
post intervention at week 72
Secondary outcome [23] 0 0
Health behaviours mean differences in summed scores between the Working Out Dads and Usual Care arms
Timepoint [23] 0 0
post intervention at week 72
Secondary outcome [24] 0 0
Me as a Parent Scale mean difference in total scale scores between the Working Out Dads and Usual Care arms.
Timepoint [24] 0 0
post intervention at week 72
Secondary outcome [25] 0 0
Child-Parent Relationhip Scale mean difference in total scale scores between the Working Out Dads and Usual Care arms.
Timepoint [25] 0 0
post intervention at week 72
Secondary outcome [26] 0 0
Parenting Warmth, hostility and engagement in home learning activities- mean difference in total summed scores between the Working Out Dads and Usual Care arms.
Timepoint [26] 0 0
post intervention at week 72
Secondary outcome [27] 0 0
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.
Timepoint [27] 0 0
post intervention at week 72

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/06/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2025
Actual
Sample size
Target
Accrual to date
Final
293
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Murdoch Children's Research Institute - Parkville
Recruitment postcode(s) [1] 0 0
3052 - Parkville

Funding & Sponsors
Primary sponsor type
Other
Name
Murdoch Childrens Research Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Melbourne
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Tweddle Child and Family Health Service
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Australian National University
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
La Trobe University
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Swinburne University of Technology
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Deakin University
Address [6] 0 0
Country [6] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Rebecca Giallo, PhD
Address 0 0
Murdoch Children's Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Rebecca Giallo, PhD
Address 0 0
Country 0 0
Phone 0 0
9936 6060
Fax 0 0
Email 0 0
rebecca.giallo@mcri.edu.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The de-identified data set collected for analysis of the WOD Trial will be available for six months after publication of the primary outcome. The study protocol, data dictionary and analysis plan will also be made available. Medicare and Pharmaseutical Benefits Scheme data will not be available. The de-identified data set will only be made available to researchers from a recognised research institute: (i) who sign a data access agreement accepting MCRI's conditions for access and appropriate acknowledgement, (ii) whose proposed use and analysis plan has been approved by the Sponsor Investigator and the Trial Steering Committee, and (iii) whose proposed use has been reviewed and accepted by the Royal Children's Hospital Human Research Ethics Committee.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
6 months after publication of primary outcome
Available to whom?
(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.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04813042