Child Development Clinical Trial
— BUDHI/SBBBOfficial title:
Developing a Sustainable Organizational Structure to Integrate Psychosocial Stimulation Programme Into Primary Health Care Services in Bangladesh [Bangladesh Undertaking Child Development and Health-system Integration (BUDHI) Project]
This study aims to establish a sustainable programme whereby early childhood development activities are integrated into the routine activities of community clinics in rural Bangladesh for undernourished children by developing a cascade of training at national, district, Upazila (sub-district), and union level to train clinic staff.
Status | Not yet recruiting |
Enrollment | 480 |
Est. completion date | December 30, 2022 |
Est. primary completion date | December 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months to 24 Months |
Eligibility | Inclusion Criteria: - Moderately and severely malnourished children - Aged 6-24 mo - Both sexes - Mid-upper arm circumference (MUAC)<12.5 cm - Parents agree to participate in the programme. Exclusion Criteria: - Children with MUAC=12.5 cm - Those whose parents do not consent to participate - Children with disability, multiple births or any congenital abnormality will be included in the intervention but excluded from the evaluation sample |
Country | Name | City | State |
---|---|---|---|
Bangladesh | International Centre for Diarrhoeal Disease Research, Bangladesh | Dhaka |
Lead Sponsor | Collaborator |
---|---|
International Centre for Diarrhoeal Disease Research, Bangladesh | Bangor University, Institute of Child Health |
Bangladesh,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cognitive function | Cognitive Composite scores on Bayley Scales of Infant and Toddler Development-III test, measuring children's cognition aged 1-42 months, ranging from 55 to 145. Higher values represent better outcome. | Through study completion, an average of 1 year | |
Primary | Language development | Language Composite scores on Bayley Scales of Infant and Toddler Development-III test, measuring children's language aged 1-42 months, ranging from 47 to 153. Higher values represent better outcome. | Through study completion, an average of 1 year | |
Secondary | Response to examiner | Wolke's Behaviour ratings measuring response to examiner of children aged 1-42 months ranging from 1-9. Higher values represent better outcome. | Through study completion, an average of 1 year | |
Secondary | Emotional Tone | Wolke's Behaviour ratings measuring emotional tone of children aged 1-42 months ranging from 1-9. Higher values represent better outcome. | Through study completion, an average of 1 year | |
Secondary | Cooperation with test procedure | Wolke's Behaviour ratings measuring cooperativeness of children aged 1-42 months ranging from 1-9. Higher values represent better outcome. | Through study completion, an average of 1 year | |
Secondary | Vocalization | Wolke's Behaviour ratings measuring vocalization of children aged 1-42 months ranging from 1-9. Higher values represent better outcome. | Through study completion, an average of 1 year | |
Secondary | Quality of home stimulation | Family Care Indicators (FCI), measuring play activities (ranging from 0-15), play materials (ranging from 0-7), books (ranging from 0-10), and magazines (ranging from 0-10), available to child at home. The sub-scales of play activities, play materials, books and magazines will be summed to make a total FCI score, ranging from 0-42. Higher values represent better outcome. | Through study completion, an average of 1 year | |
Secondary | Anthropometry | WHO standards for measuring weight in kilograms, length/height and head circumference in centimeters. These measures will be converted to Z scores for head-circumference-for-age, weight-for-age, length/height-for-age and weight-for-length/height. Values between - to +1 Z scores represent normal values and increment up to +3 Z score represent improvement. But, values more than +3 Z score are not normal. | Through study completion, an average of 1 year | |
Secondary | Maternal knowledge of child rearing | Pre-designed and previously used questionnaire measuring maternal knowledge of child development, ranging from 0-50. Higher values represent better outcome. | Through study completion, an average of 1 year | |
Secondary | Maternal depressive symptoms | Family Care Indicators measuring 6 depressive symptoms of mothers in days for the last 7 days, ranging from 0-42. Lower values represent better outcome. | Through study completion, an average of 1 year |
Status | Clinical Trial | Phase | |
---|---|---|---|
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