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Development and evaluation by randomised trial of a community-based Early Multimodal Intervention for depressed mothers and their infants in rural Rawalpindi, Pakistan
ISRCTN ISRCTN65316374
DOI 10.1186/ISRCTN65316374
ClinicalTrials.gov identifier
EudraCT number
Public title Development and evaluation by randomised trial of a community-based Early Multimodal Intervention for depressed mothers and their infants in rural Rawalpindi, Pakistan
Scientific title
Acronym EMI Trial
Serial number at source 071548
Study hypothesis The main aim of the study is to develop and then test in cluster randomised design an early multimodal psychosocial intervention targeting mothers with antenatal and postnatal depression. Our hypothesis is that infants of mothers having the intervention will have significantly better growth than the infants of mothers who do not have the intervention. The secondary aim is to investigate the mediating effects of maternal mood, social functioning, health-seeking behaviour, and the moderating effect of maternal education and socio-economic status on the intervention outcome.
Lay summary Not provided at time of registration
Ethics approval Not provided at time of registration
Study design Randomised, single-blind study with two parallel groups
Countries of recruitment Pakistan
Disease/condition/study domain Depressive disorder
Participants - inclusion criteria 1. The age range for inclusion in the study is 17 to 40 years
2. All subjects should intend to stay in the study area for at least six months
Participants - exclusion criteria Subjects will not be included in the trial if they:
1. Have a diagnosed medical condition
2. Have a significant physical or learning disability
3. Have postpartum, or other forms of psychosis
4. Are currently under psychiatric care
Anticipated start date 01/04/2005
Anticipated end date 30/06/2007
Status of trial Completed
Patient information material
Target number of participants 900 - recruitment ends on the 15th April 2006
Interventions The groups are randomised on the basis of union council (smallest rural administrative area with population of approximately 10 - 15,000).

Study area and population:
The study will be conducted in two rural sub-districts of Rawalpindi district in Northern Punjab, Pakistan. The study area consists of 40 union councils with a population of 500,000. All women in the study area, in their third trimester of pregnancy, will form the study population. Randomisation of the union councils will be carried out by the trial centre in Rawalpindi.

All recruited subjects will be interviewed by trained and clinically experienced members of the research team using the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders IV (SCID DSM-IV), a semi-structured interview for the diagnosis of psychiatric disorder. Recruitment will continue for about one year until 450 women meeting the SCID criteria for current major depressive episode are recruited into each arm of the study.

The intervention group will receive a 16-session Early Multimodal Intervention (EMI) delivered by 40 trained Lady Health Workers (LHWs) to mothers in the intervention group. Control group will receive an enhanced antenatal and postnatal follow-up by a different group of LHWs (16 structured visits monitored by the research team).

Proposed methods for protecting against sources of bias: the outcome data will be collected by an outcome assessor unaware of treatment allocation, and the mother will be asked not to reveal anything about treatment.

Sample size calculations:
Our earlier epidemiological study shows a difference of -0.62 Standard Deviation (SD) in weight for Age Z (WAZ) between case and control. The unit of randomisation is the union council. With 20 union councils in each arm (control and intervention) and 18 mothers per union council and assuming intercluster correlation of 0.05, sample size of 360 in each group would give 80% power to detect the above effect size at the same significance level. Over a period of 12 months we will recruit 450 subjects in each arm, which will allow for infant deaths, families moving out of the study area, and dropouts (our participation rate is likely to be high because:
1. The intervention is delivered at the subjects’ homes
2. Participation where existing health care is rudimentary is likely to be high
3. Subjects will be given a small incentive to allow outcome measures to be taken

Planned analysis:
Analysis will be undertaken independently by the Health Care Trials Unit, University of Manchester, under the supervision of the trial statistician, Chris Roberts. Primary analysis will be based on intention to treat, but a secondary analysis will examine the relationship between participation in the treatment and outcome. The primary outcome measure will be the growth over the postnatal year. A cost-effectiveness analysis that compares the incremental costs and outcomes (secondary as well as primary) of the intervention group relative to the control group will be carried out using a random-effects model.

The anticipated end date of this trial has been extended to 30th June 2007. The previous end date was 15th April 2006.
Primary outcome measure(s) Growth velocity of infants will be compared by assessing development at four time points over one year (at birth and at three, six and 12 months of age). The infants of all three groups will be weighed and measured using standard techniques. Anthropometry will be converted into standard deviation scores.
Secondary outcome measure(s) 1. Maternal depression will be assessed using the SCID
2. The level of severity of depression will be assessed using the Hamilton Depression Rating Scale
3. Disability will be assessed using the Brief Disability Questionnaire (BDQ), an eight-item questionnaire that rates current problems in carrying out daily activities
4. Data will also be collected on demographic, socio-economic, social support and health care-seeking characteristics of the study population
5. Service inputs will be converted into local currency units (Pakistani rupees) via unit cost templates used in earlier mental health economic studies in India and Pakistan
Sources of funding The Wellcome Trust (UK) (grant ref: 071548)
Trial website
Publications Results in http://www.ncbi.nlm.nih.gov/pubmed/18790313
Contact name Dr  Atif  Rahman
  Address Department of Psychological Medicine
Rawnsley Building
Manchester Royal Infirmary
Oxford Road
  City/town Manchester
  Zip/Postcode M20 2AE
  Country United Kingdom
  Tel +44 (0)161 276 5331
  Fax +44 (0)161 273 2135
  Email atif.rahman@ntlworld.com
Sponsor University of Manchester (UK)
  Address Third Floor Finance Office
Rawnsley Building
Manchester Royal Infirmary
Oxford Road
  City/town Manchester
  Zip/Postcode M13 9WL
  Country United Kingdom
  Tel +44 (0)161 2765278
  Fax +44 (0)161 2732135
  Email David.Walkden@manchester.ac.uk
  Sponsor website: http://www.manchester.ac.uk
Date applied 08/06/2006
Last edited 22/03/2013
Date ISRCTN assigned 08/06/2006
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