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临床试验/NCT03665246
NCT03665246已完成不适用

Evaluation of the iMBC/ECD Model on Maternal Mental Health and Child Development in Ghana

Duke University1 个研究点 分布在 1 个国家目标入组 378 人开始时间: 2018年8月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
378
试验地点
1
主要终点
Maternal Depression/Anxiety

研究概览

简要总结

The Duke research team will work with Catholic Relief Services (CRS) and lead the design and implementation of a cluster-randomized trial in Northern Ghana to assess the impact of the Integrated Mothers and Babies Course & Early Childhood Development (iMBC/ECD) intervention on the mental wellbeing of mothers of children under 2 and their children's attainment of age-appropriate developmental milestones.

详细描述

Maternal psychological disorders around the time of pregnancy and childbirth have been identified as a key risk factor for poor child development outcomes in growth, cognition, and overall child health in low- and middle-income countries (LMICs). Maternal depression during a child's infancy predicts negative behavior and lower achievement scores, as well as increased absences in elementary school), and has been identified as a significant risk factor for poor infant growth in the developing world. There is considerable evidence to suggest that a community-based intervention, delivered by trained community volunteers, can have a significant impact on perinatal depression and child development outcomes. This cluster-randomized trial in Northern Ghana will assess the impact of the Integrated Mothers and Babies Course & Early Childhood Development (iMBC/ECD) intervention on the mental wellbeing of mothers of children under 2 and their children's attainment of age-appropriate developmental milestones. In Ghana, the iMBC/ECD will be implemented in the context of the Rural Emergency Health Service and Transport project (REST II). A key activity of REST II is Community Pregnancy Surveillance and Targeted Education Sessions (C-PrES). Routine C-PrES is delivered via educational group sessions that promote the adoption of key Maternal, Neonatal and Child Health and Nutrition (MNCHN) behaviors (e.g. newborn care, exclusive breastfeeding, etc.) among pregnant women and mothers of children under age two.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Maternal Depression/Anxiety

时间窗: 6 months post-intervention

The 9 item Patient Health Questionnaire (PHQ-9) will be used to asses the mental health (depression) of mothers of children under 2. The PHQ-9 score ranges from 0-27, with higher numbers indicating higher levels of depression.

Age-appropriate Social-Emotional Development of Children Under 2 Years

时间窗: 6 months post-intervention

The Ages and Stages Questionnaire:Social Emotional-2 (ASQ: SE-2) will be used to assess the attainment of age-appropriate social emotional development. The questionnaire that is administered is based on the child's age in completed months: * ASQ:SE 2 Month Questionnaire: 1 month 0 days - 2 months 30 days * ASQ:SE 6 Month Questionnaire: 3 month 0 days - 8 months 30 days * ASQ:SE 12 Month Questionnaire: 9 months 0 days - 14 months 30 days * ASQ:SE 18 Month Questionnaire: 15 months 0 days - 20 months 30 days * ASQ:SE 24 Month Questionnaire: 21 months 0 days - 26 months 30 days

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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