Mums 4 Mums: telephone peer support for women experiencing post-natal depression
| ISRCTN | ISRCTN91450073 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN91450073 |
| Protocol serial number | PB-PG-0407-13232 |
| Sponsor | University of Warwick (UK) |
| Funder | National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme (ref: PB-PG-0407-13232) |
- Submission date
- 27/11/2008
- Registration date
- 30/01/2009
- Last edited
- 30/12/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Warwick Medical School
Gibbet Hill Campus
Coventry
CV4 7AL
United Kingdom
| Phone | +44 (0)2476 574884 |
|---|---|
| Jane.Barlow@warwick.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Exploratory randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | MUMS 4 MUMS: structured telephone peer support for women experiencing post-natal depression - a pilot and exploratory randomised controlled trial (RCT) of its clinical and cost-effectiveness |
| Study acronym | Mums 4 Mums |
| Study objectives | The current proposal aims to adapt for use in the UK a peer-support intervention shown to be effective in Canada, to pilot its use, and provide preliminary data on its effectiveness in reducing depressive symptomatology among women suffering from post-natal depression (PND). |
| Ethics approval(s) | Warwickshire Local Research Ethics Committee gave approval in June 2008 (ref: 08/H1211/94) |
| Health condition(s) or problem(s) studied | Post-natal depression |
| Intervention | Consenting participants will be randomly allocated to either intervention or standard care by a researcher independent to the study. Although blinding of service users and providers is not possible, the researchers collecting follow-up data will be blind to the allocation. Analysis of the clinical data will be carried out on an intention-to-treat basis and blind to allocation group. All participants will receive standard care; women allocated to the intervention group will also receive telephone support calls over a period of 6 months from peer supporters who have been specially trained to deliver the intervention (i.e. the same peer supporters that delivered the pilot study intervention). Outcome measures will be collected at baseline, 6 and 12 months. |
| Intervention type | Other |
| Primary outcome measure(s) |
Depressive symptomatology, measured using the Edinburgh Post-natal Depression Scale (EPDS), measured at baseline, 6 months and 12 months. |
| Key secondary outcome measure(s) |
1. Self-efficacy, e.g. Maternal Self-Efficacy Scale, Depression Coping Self-Efficacy Scale |
| Completion date | 31/03/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 80 |
| Total final enrolment | 28 |
| Key inclusion criteria | 1. Women aged greater than 16 years of age at the time of giving birth 2. Experiencing depressive symptomatology (i.e. Edinburgh Post-natal Depression Questionnaire [EPDS] greater than or equal to 13 and/or clinical judgment) 3. Receptive to receiving telephone support |
| Key exclusion criteria | 1. A score of 19 or above on the EPDS 2. Pose a suicide risk or a risk to their children 3. Receiving specialist psychiatric care or suffering from any mental illnesses (other than PND) or learning difficulties 4. Not able to speak English 5. Not accessible via the telephone |
| Date of first enrolment | 01/12/2008 |
| Date of final enrolment | 31/03/2011 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
CV4 7AL
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 25/03/2011 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
30/12/2020: The following changes have been made:
1. A thesis link has been added to the publication and dissemination plan.
2. The final enrolment number has been added from the thesis.
08/10/2018: An intention to publish date was added.
08/10/2018: No publications found, verifying study status with principal investigator.
