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	https://doi.org/10.1186/ISRCTN65316374
Secondary identifying numbers	071548

Submission date: 08/06/2006
Registration date: 08/06/2006
Last edited: 26/08/2015

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

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Atif Rahman
Scientific

Department of Psychological Medicine
Rawnsley Building
Manchester Royal Infirmary
Oxford Road
Manchester
M20 2AE
United Kingdom

Phone	+44 (0)161 276 5331
Email	atif.rahman@ntlworld.com

Study information

Study design	Randomised single-blind study with two parallel groups
Primary study design	Interventional
Secondary study design	Randomised parallel trial
Study setting(s)	Community
Study type	Treatment
Scientific title	Development and evaluation by randomised trial of a community-based Early Multimodal Intervention for depressed mothers and their infants in rural Rawalpindi, Pakistan
Study acronym	EMI Trial
Study objectives	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. The overall trial end date was extended from 15/04/2006 to 30/06/2007.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Depressive disorder
Intervention	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.
Intervention type	Other
Primary outcome measure	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 measures	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
Overall study start date	01/04/2005
Completion date	30/06/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	900
Key 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
Key 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
Date of first enrolment	01/04/2005
Date of final enrolment	15/04/2006

Locations

Countries of recruitment

England
Pakistan
United Kingdom

Study participating centre

Manchester Royal Infirmary

Manchester
M20 2AE
United Kingdom

Sponsor information

University of Manchester (UK)
University/education

Third Floor Finance Office
Rawnsley Building
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
England
United Kingdom

Phone	+44 (0)161 2765278
Email	David.Walkden@manchester.ac.uk
Website	http://www.manchester.ac.uk
"ROR"	https://ror.org/027m9bs27

Funders

Funder type

Charity

Wellcome Trust
Private sector organisation / International organizations

Location: United Kingdom

Results and Publications

Intention to publish date
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
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	13/09/2008		Yes	No
Results article	results	01/07/2015		Yes	No