Phase 1 Study of Integration of Early Child Development Interventions in a Community Health Service in Sindh, Pakistan
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,489
- 试验地点
- 2
- 主要终点
- Early Child Development
研究概览
简要总结
The purpose of this study is to evaluate whether the integration of an early child 'stimulation and care for development' intervention, either alone or in combination with an 'enhanced care for nutrition' intervention, delivered by Lady Health Workers to families with infants and young children aged 0-24 months living in rural Sindh in Pakistan, has beneficial outcomes on child development (cognitive, language, motor and social emotional development) and child growth.
详细描述
In Pakistan, the "National Program for Family Planning and Primary Healthcare" delivers maternal and child health and nutrition services in rural and remote areas of Pakistan through community-based Lady Health Workers. The strengths of the programme include provision of services at grassroots levels, reinforcement of health and basic nutrition messages and community acceptability. Given, the growing recognition that optimal early child development (ECD) also requires the integration of psychosocial care; the PEDS-Trial has been proposed to evaluate the benefits of the addition of 'stimulation and care for development' interventions and the feasibility of scaling up an ECD strategy within the community healthcare system of Pakistan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All children born in the defined geographical area of study during the study enrollment period will be eligible for the study along with their primary care giver (mother). Infant must be 1d-2.5m of age at time of enrolment.
排除标准
- •Children born with profound severe disabilities
结局指标
主要结局
Early Child Development
时间窗: 24 months of child age
Cognitive, Language, Motor, Social-Emotional development
Child Growth
时间窗: 24 months of child age
Length/Height, Weight, Mid Arm Circumference, Head Circumference
次要结局
- Caregiving Mediator: Feeding Practices(Baseline, 6 months, 12 months, 18 months and 24 months of child age)
- Caregiving Mediators: Maternal Psychological Distress (Depression)(Baseline, 6 months, 12 months, 18 months and 24 months of child age)
- Caregiving mediators: Caregiving Environment(6 months and 18 months of child age)
- Caregiving Mediator: Care for Development(Baseline, 12 months and 24 months of child age)
- Morbidity(Monthly report)
- Anaemia Status(24 months child age)
- Caregiving Mediator: Mother/Child Interaction(12 months and 24 months of child age)
研究者
Dr Aisha Khizar Yousafzai
Principal Investigator
Aga Khan University