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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

Development and evaluation by randomised trial of a community-based Early Multimodal Intervention for depressed mothers and their infants in rural Rawalpindi, Pakistan

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN65316374
Enrollment
900
Registered
2006-06-08
Start date
2005-04-01
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive disorder Mental and Behavioural Disorders Depressive disorder

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 t

Sponsors

University of Manchester (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

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

Design outcomes

Secondary

MeasureTime frame
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

Primary

MeasureTime frame
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.

Countries

Pakistan

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 4, 2026