Peer support to improve mental health outcomes following miscarriage: a mixed methods study of effectiveness and experiences
| ISRCTN | ISRCTN14271180 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14271180 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 337623 |
| Protocol serial number | IRAS 337623, NIHR 156802, CPMS 61892 |
| Sponsor | University of Liverpool |
| Funder | National Institute for Health and Care Research |
- Submission date
- 22/03/2024
- Registration date
- 26/03/2024
- Last edited
- 22/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
‘Miscarriage’ is the term used to describe the loss of pregnancy during the first 23 weeks. Experiencing miscarriage can be very traumatic. However, mental health support after miscarriage is not routinely offered by healthcare services.
Miscarriage ‘peer support’ links people with experience of miscarriage with others who have also experienced miscarriage, to provide support, hope and encouragement. Research evidence has shown that peer support after miscarriage can be helpful to parents (mothers and/or their partners) in reducing mental trauma.
This project will identify all miscarriage peer support interventions that have been written about, both in the United Kingdom and elsewhere in the world. We will then share this summary with people who both provide miscarriage peer support and people who have been offered miscarriage peer support, to compare what we have found with their personal experiences of support.
Who can participate?
We will seek a wide range of views from people including, providers from different NHS and charity organisations, and parents, aged 18 or older, who have experienced either a single or multiple miscarriage(s), within the last two years.
What does the study involve?
The study involves one-to-one interviews with a researcher to explore experiences of receiving or providing peer support following miscarriage. This will include questions such as how helpful the support was, and whether there were any barriers to taking up support and how support can be made better.
What are the possible benefits and risks of participating?
Although interviews will focus on experiences of peer support, this might bring up memories or thoughts about their miscarriage experience that participants may find upsetting or distressing. Participants will be supported by the researcher and will not be asked to answer any questions they feel uncomfortable with.
Participants will be reimbursed as a thank you for their time. Participants may also gain satisfaction from participating in research and supporting the generation of new knowledge.
Where is the study run from?
University of Liverpool (UK)
When is the study starting and how long is it expected to run for?
March 2024 to May 2026
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK).
Who is the main contact?
Dr Leanne Burton (Chief Investigator), lrburton@liverpool.ac.uk
Contact information
Public, Scientific, Principal investigator
University of Liverpool, Department of Primary Care and Mental Health, Institute of Population Health, 2nd Floor, Block H, Waterhouse Building
Liverpool
L39 3GL
United Kingdom
 ORCID ID |
0000-0002-5870-4161 |
|---|---|
| Phone | +44 1517957737 |
| lrburton@liverpool.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Qualitative in-depth individual interview study |
| Secondary study design | Qualitative investigation |
| Scientific title | Peer support intervention to improve mental health outcomes in those who have experienced miscarriage: systematic review and evidence synthesis of effects, barriers and facilitators to inform service design |
| Study objectives | To explore, with parents offered peer support following miscarriage and miscarriage peer support providers, the acceptability and accessibility of peer support interventions. |
| Ethics approval(s) |
Approved 13/08/2024, University of Liverpool Research Ethics Committee (University of Liverpool, Liverpool, L69 3GL, United Kingdom; +44 1517942000; researchethics@liverpool.ac.uk), ref: 14413 |
| Health condition(s) or problem(s) studied | Mental health for parents following miscarriage. |
| Intervention | Qualitative in-depth interviews will be undertaken with 40 peer support recipients (30 mothers; 10 partners) and 20 peer support deliverers. Interviews will be conducted on an individual basis, in a setting that is suitable to the participant (either virtual or face-to-face) and will last approximately 60 minutes. Interviews will be semi-structured and will follow a topic guide which will guide the researcher through a number of topics. |
| Intervention type | Other |
| Primary outcome measure(s) |
Measured using qualitative in-depth interview at a single time point: |
| Key secondary outcome measure(s) |
Measured using qualitative in-depth interview at a single time point: |
| Completion date | 30/05/2026 |
Eligibility
| Participant type(s) | Service user, Other |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 60 |
| Key inclusion criteria | Parents: 1. Age 18 years and over 2. Ability to give informed consent 3. Parents (mothers or partners) who have experienced miscarriage within the previous 2 years – defined as loss of pregnancy before 24 weeks gestation – and have been offered a peer support intervention in any setting. Peer Supporters 1. Any person who has experience of delivering peer support to parents following miscarriage in any setting. 2. Peer supporters must have been involved in a peer supporter role for a minimum of three months. |
| Key exclusion criteria | Parents and Peer Supporters 1. Individuals who do not sufficiently understand verbal explanations or written information in English, or who have special communication needs |
| Date of first enrolment | 01/01/2025 |
| Date of final enrolment | 30/04/2025 |
Locations
Countries of recruitment
- United Kingdom
- England
- Northern Ireland
- Scotland
- Wales
Study participating centre
Institute of Population Health
2nd Floor, Block H, Waterhouse Building
Pembroke Place
Liverpool
L69 3GL
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in non-publicly available repository, Not expected to be made available |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a non-publicly available repository and are not expected to be made available due to the sensitive nature of the data and small sample size. |
Editorial Notes
22/08/2024: The ethics approval was added.
05/04/2024: Internal review.
22/03/2024: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
