Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001273774
Ethics application status
Approved
Date submitted
14/11/2013
Date registered
19/11/2013
Date last updated
4/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Australian Father's Study: A longitudinal study of men about to become fathers and their engagement in pregnancy, birth and the early postnatal period.
Scientific title
Australian Father's Study: A longitudinal study of men about to become fathers and their engagement in pregnancy, birth and the early postnatal period.
Secondary ID [1] 283597 0
Nil
Universal Trial Number (UTN)
Trial acronym
AFS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fatherhood 290520 0
Condition category
Condition code
Reproductive Health and Childbirth 290907 290907 0 0
Normal pregnancy

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
There is no trial intervention. This is an observational study of men's engagement in the antenatal, birth and early postnatal period. Men will complete three questionnaires. One will be completed in the third trimester (between 30 and 40 weeks of their partner's pregnancy). A second after birth (between day 0 to 5 after the birth), and a third at six weeks postnatal (between weeks five and seven postnatal).
Intervention code [1] 288284 0
Not applicable
Comparator / control treatment
There is no intervention. This is an observational study. Within the study will be comparisons between men by
a) Employment (Hours worked per week and FIFO status versus not)
b) Race (ATSI verus not)
c) Age (teenage versus older)
d) Migrant status (born Australia versus not)
The primary outcome will be engagement measured using a set of five choices and validated internally (with correlation statistics) with a Likert scale score.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290891 0
Engagement in antenatal care measured using a question with a list of options (fully engaged to fully disengaged) and internally validated using correlation coefficients against a Likert scale score of engagement.
Timepoint [1] 290891 0
Third trimester
Primary outcome [2] 290892 0
Engagement in birth measured using a question with a list of options (fully engaged to fully disengaged) and internally validated using correlation coefficients against a Likert scale score of engagement.
Timepoint [2] 290892 0
Post delivery
Primary outcome [3] 290893 0
Engagement in the first six weeks postnatal measured using a question with a list of options (fully engaged to fully disengaged) and internally validated using correlation coefficients against a Likert scale score of engagement.
Timepoint [3] 290893 0
End of six weeks postnatal
Secondary outcome [1] 305561 0
Anxiety, depression and quality of life in pregnancy measured using the Hospital Anxiety and Depression Scale (HADS) and Satisfaction with Life Scale (SWLS)
Timepoint [1] 305561 0
Third trimester between weeks 30 and 40 of their partner's pregnancy
Secondary outcome [2] 305562 0
Anxiety, depression and quality of life after birth measured using the Hospital Anxiety and Depression Scale (HADS) and Satisfaction with Life Scale (SWLS)
Timepoint [2] 305562 0
Following birth (between day 0 and 5 after birth)
Secondary outcome [3] 305563 0
Anxiety, depression and quality of life after six weeks postnatal measured using the Hospital Anxiety and Depression Scale (HADS) and Satisfaction with Life Scale (SWLS)
Timepoint [3] 305563 0
Six weeks postnatal

Eligibility
Key inclusion criteria
Male who is the acknowledged father of an unborn baby
Minimum age
16 Years
Maximum age
80 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Not acknowledged by the pregnant woman as father of the unborn baby
Unable to speak english

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis
Evaluation of factors associated with engagement
Descriptive statistics
Compare continuous variables Student t test/Mann Whitney U test
Compare discrete variables Chi Square/Fisher Exact test
Multivariate analysis of variables significantly associated with engagement on univariate analysis including all variables significant at p<0.1 in model
Sample size was determined to provide power >80% and alpha error <0.05 to assess differences in engagement of 15% between men in categories under comparison (e.g. FIFO, teenage, migrant, ATSI) from the background rate in the wider cohort assumed to be 50%. The study population was selected to ensure adequate numbers of subpopulations as well as a large comparison group. This generated a sample size of 1000.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2013
Actual
1/07/2013
Date of last participant enrolment
Anticipated
Actual
31/12/2016
Date of last data collection
Anticipated
Actual
31/12/2017
Sample size
Target
1000
Accrual to date
Final
1050
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 1718 0
Joondalup Health Campus - Joondalup
Recruitment postcode(s) [1] 7560 0
6027 - Joondalup

Funding & Sponsors
Funding source category [1] 288277 0
Self funded/Unfunded
Name [1] 288277 0
Professor Julie Quinlivan
Country [1] 288277 0
Australia
Primary sponsor type
Individual
Name
Professor Julie Quinlivan
Address
Suite 106
Joondalup Health Campus
Shenton Avenue
Joondalup WA 6027
Country
Australia
Secondary sponsor category [1] 286994 0
Individual
Name [1] 286994 0
A/Prof Rodney Petersen
Address [1] 286994 0
Women's and Children's Hospital
72 King William Rd
North Adelaide SA 5006
Country [1] 286994 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290173 0
Joondalup Health Campus Ethics Committee
Ethics committee address [1] 290173 0
Executive
Joondalup Health Campus
Shenton Avenue
Joondalup WA 6027
Ethics committee country [1] 290173 0
Australia
Date submitted for ethics approval [1] 290173 0
Approval date [1] 290173 0
02/05/2013
Ethics approval number [1] 290173 0
1301

Summary
Brief summary
Prospective study of 1000 men who are the acknowledged father of an unborn baby. Men will be recruited via their partner. Following informed consent, men are followed across the antenatal period, birth and their involvement in the study concludes six weeks postpartum.
Men complete an antenatal, birth and postnatal questionnaires that addresses demographic, engagement, anxiety and depression, quality of life questionnaires and in addition questionnaires specific to each stage (antenatal focuses on pregnancy issues, birth on birth issues and postnatal on issues anticipated to arise in the first six weeks postpartum).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44350 0
Prof Julie Quinlivan
Address 44350 0
Suite 106
Joondalup Health Campus
Shenton Avenue
Joondalup WA 6027
Country 44350 0
Australia
Phone 44350 0
61 8 94009631
Fax 44350 0
Email 44350 0
julie.quinlivan@psr.gov.au
Contact person for public queries
Name 44351 0
Prof Julie Quinlivan
Address 44351 0
Suite 106
Joondalup Health Campus
Shenton Avenue
Joondalup WA 6027
Country 44351 0
Australia
Phone 44351 0
61 8 94009631
Fax 44351 0
Email 44351 0
julie.quinlivan@psr.gov.au
Contact person for scientific queries
Name 44352 0
Prof Julie Quinlivan
Address 44352 0
Suite 106
Joondalup Health Campus
Shenton Avenue
Joondalup WA 6027
Country 44352 0
Australia
Phone 44352 0
61 8 94009631
Fax 44352 0
Email 44352 0
julie.quinlivan@psr.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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