Condition category
Mental and Behavioural Disorders
Date applied
27/11/2008
Date assigned
30/01/2009
Last edited
18/01/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www2.warwick.ac.uk/fac/med

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 measures

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

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

http://www2.warwick.ac.uk/

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21439042

Publication citations

  1. 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.

Additional files

Editorial Notes