Mums 4 Mums: telephone peer support for women experiencing post-natal depression
| ISRCTN | ISRCTN91450073 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN91450073 |
| Secondary identifying numbers | 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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Jane Barlow
Scientific
Scientific
Warwick Medical School
Gibbet Hill Campus
Coventry
CV4 7AL
United Kingdom
| Phone | +44 (0)2476 574884 |
|---|---|
| Jane.Barlow@warwick.ac.uk |
Study information
| Study design | Exploratory randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | Depressive symptomatology, measured using the Edinburgh Post-natal Depression Scale (EPDS), measured at baseline, 6 months and 12 months. |
| Secondary outcome measures | 1. Self-efficacy, e.g. Maternal Self-Efficacy Scale, Depression Coping Self-Efficacy Scale 2. Parenting stress, e.g. Parenting Stress Inventory (PSI) 3. Maternal loneliness, e.g. Loneliness Scale 4. Maternal satisfaction with peer support, e.g. Peer Support Evaluation Inventory 5. Peer supporters' experience, e.g. Peer Volunteer Experience Questionnaire Outcomes will be measured at baseline, 6 months and 12 months. |
| Overall study start date | 01/12/2008 |
| Completion date | 31/03/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Warwick Medical School
Coventry
CV4 7AL
United Kingdom
CV4 7AL
United Kingdom
Sponsor information
University of Warwick (UK)
University/education
University/education
University House
Coventry
CV4 7AL
England
United Kingdom
| Website | http://www2.warwick.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/01a77tt86 |
Funders
Funder type
Government
National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme (ref: PB-PG-0407-13232)
No information available
Results and Publications
| Intention to publish date | 31/12/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration 2018 results in thesis http://wrap.warwick.ac.uk/114368/ |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 25/03/2011 | Yes | No |
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.
