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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04813042
Registration number
NCT04813042
Ethics application status
Date submitted
10/03/2021
Date registered
24/03/2021
Date last updated
13/09/2023
Titles & IDs
Public title
Determining the Effectiveness of Working Out Dads to Reduce Mental Health Difficulties in Fathers of Young Children
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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
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Secondary ID [1]
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69411
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Universal Trial Number (UTN)
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Trial acronym
WOD
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Mental Health Issue
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0
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Behaviour - Working Out Dads
Behaviour - 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.
Behaviour: 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.
Behaviour: 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.
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Intervention code [1]
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Behaviour
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Kessler Psychological Distress Scale, mean difference in total scale scores between the Working Out Dads and Usual Care arms
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Assessment method [1]
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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.
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Timepoint [1]
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post intervention at week 24
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Secondary outcome [1]
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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
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Assessment method [1]
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The Mini International Neuropsychiatric Interview (MINI) will be used to determine clinically significant depressive, suicidal or anxiety mental health disorders. Administered via telephone by trained staff, this 15-minute structured diagnostic interview assesses 17 common DSM-5 and ICD-10 psychiatric disorders. It is well validated for use in clinical trials and epidemiological studies. In this prevention trial, we predict a higher proportion of fathers in the usual care arm (vs. the intervention arm) will have ongoing or emerging clinically significant depressive, suicidal or anxiety mental health disorders by 6 months
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Timepoint [1]
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post intervention at week 24
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Secondary outcome [2]
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The Depression Anxiety Stress Scale-21mean difference scale scores between Working Out Dads and Usual Care arms
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Assessment method [2]
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The Depression Anxiety Stress Scale-21 (DASS-21) assesses symptoms of depression, anxiety, and stress in the past week (21 items). Scores on each scale range from 0-42 with higher scores indicating a greater severity of symptoms.Clinical ranges are available. Excellent reliability and validity has been demonstrated in Australian population-based samples. The DASS-21 is routinely used by early parenting services.
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Timepoint [2]
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post intervention at week 10
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Secondary outcome [3]
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The Depression Anxiety Stress Scale-21 mean difference scale scores between the Working Out Dads and Usual Care arms
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Assessment method [3]
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The Depression Anxiety Stress Scale-21 (DASS-21) assesses symptoms of depression, anxiety, and stress in the past week (21 items). Scores on each scale range from 0-42 with higher scores indicating a greater severity of symptoms. Clinical ranges are available. Excellent reliability and validity has been demonstrated in Australian population-based samples. The DASS-21 is routinely used by early parenting services.
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Timepoint [3]
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post intervention at week 24
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Secondary outcome [4]
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The Depression Anxiety Stress Scale-21 mean difference scale scores between the Working Out Dads and Usual Care arms
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Assessment method [4]
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The Depression Anxiety Stress Scale-21 (DASS-21) assesses symptoms of depression, anxiety, and stress in the past week (21 items). Scores on each scale range from 0-42 with higher scores indicating a greater severity of symptoms. Clinical ranges are available. Excellent reliability and validity has been demonstrated in Australian population-based samples. The DASS-21 is routinely used by early parenting services.
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Timepoint [4]
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post intervention at week 72
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Secondary outcome [5]
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The Suicidal Ideation Attributes Scale mean difference in total scale scores between the Working Out Dads and Usual Care arms
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Assessment method [5]
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The Suicidal Ideation Attributes Scale is a 5-item screener for the presence and severity of suicidal thoughts in the last month based on frequency, controllability, closeness to attempt, level of distress, and impact on daily functioning. Scores range from 0-50 with higher scores indicating a greater severity of suicidal ideation. Any ideation is indicative of risk for suicidal behaviour; scores >21 indicate high risk. Online administration has been validated (N=1352 Australian adults), and it has excellent reliability (Cronbach a=0.91) and validity.
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Timepoint [5]
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post intervention at week 10
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Secondary outcome [6]
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The Suicidal Ideation Attributes Scale mean difference in total scale scores between the Working Out Dads and Usual Care arms
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Assessment method [6]
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The Suicidal Ideation Attributes Scale is a 5-item screener for the presence and severity of suicidal thoughts in the last month based on frequency, controllability, closeness to attempt, level of distress, and impact on daily functioning. Scores range from 0-50 with higher scores indicating a greater severity of suicidal ideation. Any ideation is indicative of risk for suicidal behaviour; scores >21 indicate high risk. Online administration has been validated (N=1352 Australian adults), and it has excellent reliability (Cronbach a=0.91) and validity.
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Timepoint [6]
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post intervention at week 24
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Secondary outcome [7]
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The Suicidal Ideation Attributes Scale mean difference in total scale scores between the Working Out Dads and Usual Care arms
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Assessment method [7]
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The Suicidal Ideation Attributes Scale is a 5-item screener for the presence and severity of suicidal thoughts in the last month based on frequency, controllability, closeness to attempt, level of distress, and impact on daily functioning. Scores range from 0-50 with higher scores indicating a greater severity of suicidal ideation. Any ideation is indicative of risk for suicidal behaviour; scores >21 indicate high risk. Online administration has been validated (N=1352 Australian adults), and it has excellent reliability (Cronbach a=0.91) and validity.
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Timepoint [7]
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post intervention at week 72
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Secondary outcome [8]
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The Medical Outcomes Study-Social Support Survey mean difference in total scale scores between the Working Out Dads and Usual Care arms
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Assessment method [8]
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The Medical Outcomes Study-Social Support Survey (MSSS). The 14 items assess tangible, emotional, affective and positive support. Scores range from 14-70 with higher scores indicating greater levels of perceived social support. Excellent reliability (Cronbach's a=0.88) and validity have been established.
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Timepoint [8]
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post intervention at week 24
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Secondary outcome [9]
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The Medical Outcomes Study-Social Support Survey mean difference in total scale scores between the Working Out Dads and Usual Care arms
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Assessment method [9]
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The Medical Outcomes Study-Social Support Survey (MSSS). The 14 items assess tangible, emotional, affective and positive support. Scores range from 14-70 with higher scores indicating greater levels of perceived social support. Excellent reliability (Cronbach's a=0.88) and validity have been established.
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Timepoint [9]
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post intervention at week 10
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Secondary outcome [10]
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The Medical Outcomes Study-Social Support Survey mean difference in total scale scores between the Working Out Dads and Usual Care arms
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Assessment method [10]
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The Medical Outcomes Study-Social Support Survey (MSSS). The 14 items assess tangible, emotional, affective and positive support. Scores range from 14-70 with higher scores indicating greater levels of perceived social support. Excellent reliability (Cronbach's a=0.88) and validity have been established.
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Timepoint [10]
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post intervention at week 72
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Secondary outcome [11]
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Perceived Need for Care Questionnaire (modified version), mean difference in proportion with unmet need between the Working Out Dads and Usual Care arms
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Assessment method [11]
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A modified version of the Perceived Need for Care Questionnaire will be used to ask fathers if they needed mental health care but could not access (same time period). Fathers will be as either as either 0= having no unmet need, or 1= having unmet needs.
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Timepoint [11]
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post intervention at week 24
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Secondary outcome [12]
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Perceived Need for Care Questionnaire (modified version), mean difference in proportion with unmet need between the Working Out Dads and Usual Care arms
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Assessment method [12]
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A modified version of the Perceived Need for Care Questionnaire will be used to ask fathers if they needed mental health care but could not access (same time period). Fathers will be as either as either 0= having no unmet need, or 1= having unmet needs.
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Timepoint [12]
0
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post intervention at week 72
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Secondary outcome [13]
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The Revised Attitudes Towards Seeking Professional Psychological Help Scale mean difference in total scale scores between the Working Out Dads and Usual Care arms
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Assessment method [13]
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The 10-item Revised Attitudes Towards Seeking Professional Psychological Help Scale.Scores range from 0-30 with higher scores indicating a more positive attitude towards help-seeking. Excellent reliability has been established in Australian samples (Cronbach's a=0.77).
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Timepoint [13]
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post intervention at week 24
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Secondary outcome [14]
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The Karitane Parenting Confidence Scale mean difference in total scale scores between the Working Out Dads and Usual Care arms
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Assessment method [14]
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The Karitane Parenting Confidence Scale (KPCS) is a 15-item measure that assesses parents' perceived parenting self-efficacy or sense of competence in their parenting abilities. Scores range from 0-45 with higher scores indicating a greater level of parenting self-efficacy. The scale has documented excellent internal consistency, test-retest reliability, convergent and discriminant validity with mothers of young children.
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Timepoint [14]
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post intervention at week 24
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Secondary outcome [15]
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The Child-Parent Relationship Scale- short form mean difference in total scale scores between the Working Out Dads and Usual Care arms
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Assessment method [15]
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The Child-Parent Relationship Scale- short form (CPRS) is a 15-item measure which assess parents' perceptions of their relationship with their child. The measure is comprised of two subscales: closeness and conflict. Scores on the Conflict subscale range between 8-40 with higher scores indicating greater levels of perceived parent-child conflict. Scores on the closeness subscale range between 7-35 with higher scores indicating greater parent-child closeness.
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Timepoint [15]
0
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post intervention at week 24
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Secondary outcome [16]
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Health Service Use cost, mean difference in cost of healthcare use between the Working Out Dads and Usual Care arms
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Assessment method [16]
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Service use will be assessed by self-reported cost of healthcare services accessed (prior to baseline and during the study period) and by examination of Medicare data. Higher cost will indicate a greater expense of health care use.
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Timepoint [16]
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post intervention at week 24
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Secondary outcome [17]
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Health Service Use, mean difference in number of healthcare use between the Working Out Dads and Usual Care arms
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Assessment method [17]
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Service use will be assessed by self-reported number of healthcare services accessed (prior to baseline and during the study period) and by examination of Medicare data. Higher numbers will indicate a higher frequency of health care use.
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Timepoint [17]
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post intervention at week 24
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Secondary outcome [18]
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Health Service Use, mean difference in number of healthcare use between the Working Out Dads and Usual Care arms
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Assessment method [18]
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Service use will be assessed by self-reported number of healthcare services accessed (prior to baseline and during the study period) and by examination of Medicare data. Higher numbers will indicate a higher frequency of health care use.
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Timepoint [18]
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post intervention at week 72
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Secondary outcome [19]
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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
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Assessment method [19]
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The Assessment of Quality of Life 8 dimension (AQoL-8D), is a validated tool assessing quality of life impacts in the economic evaluation. Australian population normative data are available and will be used to determine preference weighted health related quality of life utility scores ranging from 0-1 with higher scores indicating higher quality of life. The AQoL-8D is particularly suited to measuring mental health aspects of quality of life.
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Timepoint [19]
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post intervention at week 24
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Secondary outcome [20]
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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
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Assessment method [20]
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The Assessment of Quality of Life 8 dimension (AQoL-8D), is a validated tool assessing quality of life impacts in the economic evaluation. Australian population normative data are available and will be used to determine preference weighted health related quality of life utility scores ranging from 0-1 with higher scores indicating higher quality of life. The AQoL-8D is particularly suited to measuring mental health aspects of quality of life.
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Timepoint [20]
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post intervention at week 72
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Secondary outcome [21]
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The Kessler Psychological Distress Scale mean difference in total scale scores between the Working Out Dads and Usual Care arms
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Assessment method [21]
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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.
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Timepoint [21]
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post intervention at week 10
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Secondary outcome [22]
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The Kessler Psychological Distress Scale mean difference in total scale scores between the Working Out Dads and Usual Care arms
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Assessment method [22]
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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.
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Timepoint [22]
0
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post intervention at week 72
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Secondary outcome [23]
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Health behaviours mean differences in summed scores between the Working Out Dads and Usual Care arms
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Assessment method [23]
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Questions related to alcohol use and physical activity from the AUDIT-C and Active Australia Study, respectively, have been included. Seven study designed items have been developed to ask fathers about the extent to which they are engaging in positive health behaviours (e.g., had enough rest and sleep, exercised regularly, had time to self, spent time with family, friends, and partner).
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Timepoint [23]
0
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post intervention at week 72
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Secondary outcome [24]
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Me as a Parent Scale mean difference in total scale scores between the Working Out Dads and Usual Care arms.
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Assessment method [24]
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The Me as a Parent Scale (MaaPS) is a 16-item scale assessing parent beliefs about self-efficacy, personal agency, self-management and self-sufficiency.
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Timepoint [24]
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post intervention at week 72
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Secondary outcome [25]
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Child-Parent Relationhip Scale mean difference in total scale scores between the Working Out Dads and Usual Care arms.
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Assessment method [25]
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The Child-Parent Relationship Scale- short form (CPRS)[39] is a 15-item measure which assess parents' perceptions of their relationship with their child.
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Timepoint [25]
0
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post intervention at week 72
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Secondary outcome [26]
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Parenting Warmth, hostility and engagement in home learning activities- mean difference in total summed scores between the Working Out Dads and Usual Care arms.
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Assessment method [26]
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Parenting hostility will be assessed using four adapted items from the Early Childhood Longitudinal Study of Children. Fathers will rate how often they engage in hostile behaviours during interactions with their child. Parenting warmth will be assessed using a modified six-item subscale from the Child Rearing Questionnaire. Fathers will indicate how often they feel close to and express affection toward their child. Parental Involvement Scale is a five-item scale taken from the Growing Up in Australia: Longitudinal Study of Australian Children assessing the frequency in which parents have done the following activities with their child: read from a book, told a story (not from a book), played with toys/games indoors (e.g., board/card games), involved them in everyday activities at home (e.g., cooking/caring for pets), and played a game outdoors or exercise together (e.g., walking, swimming).
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Timepoint [26]
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post intervention at week 72
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Secondary outcome [27]
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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.
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Assessment method [27]
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Study specific questions have been developed to ask fathers about what activities (e.g., joined a fathers' group, stayed in contact with other fathers) they have engaged in since participating in WOD or usual care.
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Timepoint [27]
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post intervention at week 72
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
Yes
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
24/06/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/11/2024
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Actual
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Sample size
Target
280
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Murdoch Children's Research Institute - Parkville
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Recruitment postcode(s) [1]
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3052 - Parkville
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Funding & Sponsors
Primary sponsor type
Other
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Name
Murdoch Childrens Research Institute
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Address
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Country
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Other collaborator category [1]
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0
Other
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Name [1]
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University of Melbourne
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Address [1]
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0
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Country [1]
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0
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Other collaborator category [2]
0
0
Other
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Name [2]
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0
Tweddle Child and Family Health Service
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Address [2]
0
0
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Country [2]
0
0
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Other collaborator category [3]
0
0
Other
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Name [3]
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0
Australian National University
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Address [3]
0
0
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Country [3]
0
0
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Other collaborator category [4]
0
0
Other
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Name [4]
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La Trobe University
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Address [4]
0
0
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0
0
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Other collaborator category [5]
0
0
Other
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Name [5]
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0
Swinburne University of Technology
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Address [5]
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0
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0
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Other collaborator category [6]
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0
Other
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Name [6]
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Deakin University
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Address [6]
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Country [6]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04813042
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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0
Rebecca Giallo, PhD
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Address
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Murdoch Children's Research Institute
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Country
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0
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Phone
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0
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Fax
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0
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Email
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0
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Contact person for public queries
Name
0
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Rebecca Giallo, PhD
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Address
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Country
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0
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Phone
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9936 6060
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Fax
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0
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04813042
Download to PDF