The Mental Well-being of Fathers and Partners

Mental Health Disorder Clinical Trial

Official title:

The Mental Well-being of Fathers and Partners of Women Accessing Perinatal Mental Health Services

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04971460
• Other study ID #: 291920
• Status: Completed
• Start date: July 24, 2021
• Est. completion date: May 31, 2022

Study information

• Verified date: April 2021
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to assess the acceptability and feasibility of screening common mental health difficulties in fathers and partners of women accessing perinatal mental health services.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 70 Years

Eligibility

Inclusion Criteria:

Fathers and partners of women:

1. Admitted to the SLaM Mother and Baby Unit or

2. Seen by SLaM Community Perinatal Mental Health services or

3. 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

Related Conditions & MeSH terms

• Fathers
• Mental Disorders
• Mental Health Disorder

Locations

Country	Name	City	State
United Kingdom	King's College London	London

Sponsors (2)

Lead Sponsor	Collaborator
King's College London	South London and Maudsley NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	How many partners/fathers complete the screening questionnaires	How many partners/fathers complete the screening questionnaires online over the 6-month recruitment period.	6-months
Secondary	Prevalence of mental health difficulties	To estimate the prevalence of common mental health difficulties in three study groups: fathers and partners of women admitted to a Mother and Baby Unit; fathers and partners of women accessing community perinatal mental health services; fathers and partners of women who are not accessing mental health services in the perinatal period	6-months