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]
试验速览
- 阶段
- 不适用
- 入组人数
- 480
- 试验地点
- 2
- 主要终点
- Cognitive function
研究概览
简要总结
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.
详细描述
Background (brief):
- Burden: Approximately 250 million children under 5 years of age in developing countries do not reach their full potential due to poverty, malnutrition and lack of a stimulating environment. It is estimated that in Bangladesh 44% of the population live below the international poverty line, and 36% of children under 5 years are stunted. Bangladeshi children showed a significant cognitive deficit as early as 7 months of age compared to more affluent children and the deficit grew bigger as children reached 5 years of age.
- Knowledge gap: Several studies in developing countries have shown benefits of early childhood interventions to development of under-5 children. The curriculum of early childhood intervention 'Reach up' has been adapted for Bangladesh and used in 6 trials in Bangladesh. All the projects found consistent significant benefits on the developmental outcomes of children. Two recent trials were conducted in community clinics (CCs), integrating early childhood development (ECD) activities with Govt primary health service and there is a need to determine if the intervention can be taken to scale.
- Relevance:
Bangladesh Govt acknowledges the need for improving children's development and has agreed to collaborate and implement ECD activities at large scale in addition to funding it.
Hypothesis (if any): We hypothesize that it is feasible to train GoB staff at District, Upazila (Sub-district), Union and CC levels and integrate ECD activities in CCs in Bangladesh and thereby improve undernourished children's development after a year of intervention.
Objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Cognitive function
时间窗: Through study completion, an average of 1 year
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.
Language development
时间窗: Through study completion, an average of 1 year
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.
次要结局
- Response to examiner(Through study completion, an average of 1 year)
- Emotional Tone(Through study completion, an average of 1 year)
- Cooperation with test procedure(Through study completion, an average of 1 year)
- Vocalization(Through study completion, an average of 1 year)
- Quality of home stimulation(Through study completion, an average of 1 year)
- Anthropometry(Through study completion, an average of 1 year)
- Maternal knowledge of child rearing(Through study completion, an average of 1 year)
- Maternal depressive symptoms(Through study completion, an average of 1 year)