NCT04971460

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 21, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

July 24, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
Last Updated

September 23, 2022

Status Verified

April 1, 2021

Enrollment Period

10 months

First QC Date

May 10, 2021

Last Update Submit

September 22, 2022

Conditions

Keywords

FathersPerinatal

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Prevalence of mental health difficulties

    6-months

Study Arms (3)

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

Eligibility Criteria

Age16 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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).

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King's College London

London, SE5 8AF, United Kingdom

Location

MeSH Terms

Conditions

Mental Disorders

Study Officials

  • Vaheshta Sethna, DPhil

    King's College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2021

First Posted

July 21, 2021

Study Start

July 24, 2021

Primary Completion

May 31, 2022

Study Completion

May 31, 2022

Last Updated

September 23, 2022

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations