- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04971460
The Mental Well-being of Fathers and Partners
The Mental Well-being of Fathers and Partners of Women Accessing Perinatal Mental Health Services
Study Overview
Status
Conditions
Detailed Description
Where women have mental health disorders, this can put significant strain on their partners. As well as supporting the mother and dealing with worries and uncertainty about her wellbeing, partners may take on additional childcare and household duties alongside maintaining work commitments. As a result, mental health professionals are considering ways to involve and support partners and other family members where women are accessing specialist services.
This feasibility study will involve the screening of fathers/partners of women accessing perinatal mental health services, for mental health disorders including depression, anxiety disorders and post-traumatic stress disorder (PTSD). Previous empirical evidence has largely focussed on fathers but we will include partners i.e., whoever the mother identifies as her partner, therefore including individuals in same sex relationships or when the main partner is a stepparent. The screening questionnaires will help us to understand the mental health needs of fathers/partners of women who are being cared for by perinatal mental health services. This will also help us see if partners find it acceptable to complete questionnaires on their mental health and family functioning online.
Three groups of participants will be approached across a 6-month period. The first; fathers/partners of women being treated in a Mother and Baby Unit. The second; fathers/partners of women being treated in community services (i.e. community Perinatal Mental Health Services). The third; fathers/partners of women who have not experienced mental health difficulties in the perinatal period.
Fathers/partners in the clinical groups will initially be approached by clinicians in the relevant service (Mother and Baby Unit or Community Perinatal Mental Health Teams). They will be asked for verbal consent to be contacted by the research team. The research team will then contact the participant and provide further information about the study and obtain informed consent. Participants in the control group will be recruited online via social media and through local charities and community groups.
Fathers/partners will be invited to complete screening questionnaires on their mental wellbeing -(the Edinburgh Post-natal Depression Scale (EPDS), the Gotland Male Depression Scale, the Generalised Anxiety Disorder-7 scale (GAD-7), the City Birth Trauma Scale), a demographic questionnaire and the Couple's Satisfaction Index. Participants will be able to complete these questionnaires online or via hard copies.
The study will help to inform our understanding of whether fathers/partners find it acceptable to complete mental health screening questionnaires. It will also help to identify if fathers/partners are more at risk of developing mental health difficulties if the mother is also experiencing a mental health difficulty.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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London, United Kingdom, SE5 8AF
- King's College London
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Fathers and partners of women:
- Admitted to the SLaM Mother and Baby Unit or
- Seen by SLaM Community Perinatal Mental Health services or
Not accessing a mental health service currently or during the perinatal period (pregnancy to 12-months postpartum).
- Biological father, step-father, same sex partner or any other adult that identifies as the woman's 'primary' partner.
- Women who are pregnant or up to 12-months post-partum
- Adult fathers/partner aged 18 years and above
- Father/partner has proficient level of English to complete screening questionnaires.
- Father/partner has the ability to complete questionnaires electronically on a phone/table/computer or to complete paper questionnaires
- Father/partner is able to give informed consent and comply with study procedures
Exclusion Criteria:
Fathers and partners
- Unable to provide consent to complete questionnaires Women
- In the 'healthy' group - if the mother is accessing mental health services or has done during the perinatal period (pregnancy to 12-months postpartum) Infant offspring
- Aged over 12 months
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Mother and Baby Unit
Fathers and partners of women admitted to a Mother and Baby Unit
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Peri-natal Community Mental Health Services
Fathers and partners of women accessing community perinatal mental health services
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Control group
Fathers and partners of women who are not accessing mental health services in the perinatal period
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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How many partners/fathers complete the screening questionnaires
Time Frame: 6-months
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How many partners/fathers complete the screening questionnaires online over the 6-month recruitment period.
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6-months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prevalence of mental health difficulties
Time Frame: 6-months
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To estimate the prevalence of common mental health difficulties in three study groups:
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6-months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Vaheshta Sethna, DPhil, King's College London
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 291920
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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