Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
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 |
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 |
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 |
post intervention at week 24 |
|
| Secondary |
The Depression Anxiety Stress Scale-21mean difference scale scores between Working Out Dads and Usual Care arms |
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. |
post intervention at week 10 |
|
| Secondary |
The Depression Anxiety Stress Scale-21 mean difference scale scores between the Working Out Dads and Usual Care arms |
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. |
post intervention at week 24 |
|
| Secondary |
The Depression Anxiety Stress Scale-21 mean difference scale scores between the Working Out Dads and Usual Care arms |
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. |
post intervention at week 72 |
|
| Secondary |
The Suicidal Ideation Attributes Scale mean difference in total scale scores between the Working Out Dads and Usual Care arms |
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. |
post intervention at week 10 |
|
| Secondary |
The Suicidal Ideation Attributes Scale mean difference in total scale scores between the Working Out Dads and Usual Care arms |
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. |
post intervention at week 24 |
|
| Secondary |
The Suicidal Ideation Attributes Scale mean difference in total scale scores between the Working Out Dads and Usual Care arms |
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. |
post intervention at week 72 |
|
| Secondary |
The Medical Outcomes Study-Social Support Survey mean difference in total scale scores between the Working Out Dads and Usual Care arms |
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. |
post intervention at week 24 |
|
| Secondary |
The Medical Outcomes Study-Social Support Survey mean difference in total scale scores between the Working Out Dads and Usual Care arms |
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. |
post intervention at week 10 |
|
| Secondary |
The Medical Outcomes Study-Social Support Survey mean difference in total scale scores between the Working Out Dads and Usual Care arms |
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. |
post intervention at week 72 |
|
| Secondary |
Perceived Need for Care Questionnaire (modified version), mean difference in proportion with unmet need between the Working Out Dads and Usual Care arms |
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. |
post intervention at week 24 |
|
| Secondary |
Perceived Need for Care Questionnaire (modified version), mean difference in proportion with unmet need between the Working Out Dads and Usual Care arms |
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. |
post intervention at week 72 |
|
| Secondary |
The Revised Attitudes Towards Seeking Professional Psychological Help Scale mean difference in total scale scores between the Working Out Dads and Usual Care arms |
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). |
post intervention at week 24 |
|
| Secondary |
The Karitane Parenting Confidence Scale mean difference in total scale scores between the Working Out Dads and Usual Care arms |
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. |
post intervention at week 24 |
|
| Secondary |
The Child-Parent Relationship Scale- short form mean difference in total scale scores between the Working Out Dads and Usual Care arms |
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. |
post intervention at week 24 |
|
| Secondary |
Health Service Use cost, mean difference in cost of healthcare use between the Working Out Dads and Usual Care arms |
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. |
post intervention at week 24 |
|
| Secondary |
Health Service Use, mean difference in number of healthcare use between the Working Out Dads and Usual Care arms |
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. |
post intervention at week 24 |
|
| Secondary |
Health Service Use, mean difference in number of healthcare use between the Working Out Dads and Usual Care arms |
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. |
post intervention at week 72 |
|
| Secondary |
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 |
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. |
post intervention at week 24 |
|
| Secondary |
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 |
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. |
post intervention at week 72 |
|
| Secondary |
The 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 10 |
|
| Secondary |
The 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 72 |
|
| Secondary |
Health behaviours mean differences in summed scores between the Working Out Dads and Usual Care arms |
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). |
post intervention at week 72 |
|
| Secondary |
Me as a Parent Scale mean difference in total scale scores between the Working Out Dads and Usual Care arms. |
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. |
post intervention at week 72 |
|
| Secondary |
Child-Parent Relationhip Scale mean difference in total scale scores between the Working Out Dads and Usual Care arms. |
The Child-Parent Relationship Scale- short form (CPRS)[39] is a 15-item measure which assess parents' perceptions of their relationship with their child. |
post intervention at week 72 |
|
| Secondary |
Parenting Warmth, hostility and engagement in home learning activities- mean difference in total summed scores between the Working Out Dads and Usual Care arms. |
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). |
post intervention at week 72 |
|
| Secondary |
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. |
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. |
post intervention at week 72 |
|
