Development and evaluation by randomised trial of a community-based Early Multimodal Intervention for depressed mothers and their infants in rural Rawalpindi, Pakista
Not Applicable
Completed
- Conditions
- Depressive disorderMental and Behavioural Disorders
- Registration Number
- ISRCTN65316374
- Lead Sponsor
- niversity of Manchester (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 900
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method 1. Maternal depression will be assessed using the SCID<br>2. The level of severity of depression will be assessed using the Hamilton Depression Rating Scale<br>3. Disability will be assessed using the Brief Disability Questionnaire (BDQ), an eight-item questionnaire that rates current problems in carrying out daily activities<br>4. Data will also be collected on demographic, socio-economic, social support and health care-seeking characteristics of the study population<br>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