Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Prof Jane Barlow
ORCID ID
Contact details
Warwick Medical School
Gibbet Hill Campus
Coventry
CV4 7AL
United Kingdom
+44 (0)2476 574884
Jane.Barlow@warwick.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PB-PG-0407-13232
Study information
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
Acronym
Mums 4 Mums
Study hypothesis
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
Warwickshire Local Research Ethics Committee gave approval in June 2008 (ref: 08/H1211/94)
Study design
Exploratory randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
01/12/2008
Overall trial end date
31/03/2011
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
80
Participant 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
Recruitment start date
01/12/2008
Recruitment end date
31/03/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Warwick Medical School
Coventry
CV4 7AL
United Kingdom
Sponsor information
Organisation
University of Warwick (UK)
Sponsor details
University House
Coventry
CV4 7AL
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme (ref: PB-PG-0407-13232)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
31/12/2018
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21439042
Publication citations
-
Protocol
Caramlau I, Barlow J, Sembi S, McKenzie-McHarg K, McCabe C, Mums 4 Mums: structured telephone peer-support for women experiencing postnatal depression. Pilot and exploratory RCT of its clinical and cost effectiveness., Trials, 2011, 12, 88, doi: 10.1186/1745-6215-12-88.