Mental Health DisorderNCT04971460
The Mental Well-being of Fathers and Partners
An observational study of Mental Health Disorder and Fathers, run by King's College London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 16 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Disorder, Fathers
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Jul 2021to 31 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Three groups of fathers/partners will be invited to take part in the study - fathers/partners of women being treated in a mother and baby unit, fathers/partners of women being treated in community services and fathers/partners of women who are not accessing mental health services. Participants will be recruited via the SLaM Mother and Baby Unit and Community perinatal teams. The community sample will be recruited online via social media and through local community groups/charities. Fathers/partners in the community sample will be asked to confirm that the mother is not currently accessing mental health services and hasn't accessed mental health services during the perinatal period (pregnancy to 12-months post-partum).
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Mental Well-being of Fathers and Partners of Women Accessing Perinatal Mental Health Services
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.
Read the 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.
- Conditions
- Mental Health Disorder, Fathers
- Keywords
- Fathers, Perinatal
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Mother and Baby Unit | Fathers and partners of women admitted to a Mother and Baby Unit | |
| Peri-natal Community Mental Health Services | Fathers and partners of women accessing community perinatal mental health services | |
| Control group | Fathers and partners of women who are not accessing mental health services in the perinatal period |
What is being measured
The primary outcome is the main question the study is designed to answer.
How many partners/fathers complete the screening questionnaires
How many partners/fathers complete the screening questionnaires online over the 6-month recruitment period.
Measured: 6-months
Secondary outcomes (1)
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
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start24 Jul 2021
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health DisorderStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Vaheshta Sethna, DPhil, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04971460
- Sponsor's protocol ID
- 291920
- Status last verified
- Apr 2021
- First submitted
- 10 May 2021
- Last updated
- 23 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Mental Well-being of Fathers and Partners of Women Accessing Perinatal Mental Health Services
- ClinicalTrials.gov ID
- NCT04971460
- Acronym / sponsor ID
- 291920
- Conditions
- Mental Health Disorder, Fathers
- Keywords
- Fathers, Perinatal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust
- Study start
- 24 Jul 2021 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 21 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mother and Baby Unit | – | –Fathers and partners of women admitted to a Mother and Baby Unit |
| Peri-natal Community Mental Health Services | – | –Fathers and partners of women accessing community perinatal mental health services |
| Control group | – | –Fathers and partners of women who are not accessing mental health services in the perinatal period |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Three groups of fathers/partners will be invited to take part in the study - fathers/partners of women being treated in a mother and baby unit, fathers/partners of women being treated in community services and fathers/partners of women who are not accessing mental health services. Participants will be recruited via the SLaM Mother and Baby Unit and Community perinatal teams. The community sample will be recruited online via social media and through local community groups/charities. Fathers/partners in the community sample will be asked to confirm that the mother is not currently accessing mental health services and hasn't accessed mental health services during the perinatal period (pregnancy to 12-months post-partum).
Key inclusion criteria (10 listed)
- 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).
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
How many partners/fathers complete the screening questionnaires
Time frame: 6-months
How many partners/fathers complete the screening questionnaires online over the 6-month recruitment period.
1 secondary outcome
Prevalence of mental health difficulties
Time frame: 6-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vaheshta Sethna, DPhil principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Health Disorder and Fathers, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
How many partners/fathers complete the screening questionnaires (time frame: 6-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2022.