Effect of Integrated Management of Childhood Maltreatment, Maternal Depression, Psychosocial Stimulation and Nutritional Intervention on Child Development - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 306
- 试验地点
- 1
- 主要终点
- Cognitive development (composite score of cognitive,motor, language and social-emotional development of children)
研究概览
简要总结
Background (brief):
- Burden: The uniqueness of each child is tremendously influenced by interaction between nature and nurture during critical period of brain development that promotes foundation of brain architecture through neuronal connections.
- Knowledge gap: Young children in Bangladesh are prone to multiple physiological and psycho-social risk factors e.g. poverty, maltreatment, malnutrition, disease, parental illiteracy, maternal depression and lack of stimulation, all of which are preventable. Little is reported about any comprehensive package of development that addresses most of these early childhood risks and promotes optimum early childhood development (ECD).
- Relevance: The aim of this study is to develop and evaluate an integrated, low cost, and feasible center based approach that focuses on positive parenting of children during early life that will promote early stimulation, minimize childhood maltreatment, boost up of maternal self-esteem and healthy thinking and improve health and nutritional (HN) status of children.
Hypothesis (if any):
This integrated intervention will promote maternal child-care practices and mental health that will finally improve their children's growth, micro-nutrient status, early brain development compared to control group.
Objectives:
To see the effect of an integrated intervention (ECD + HN) on growth, micro-nutrient status, child development along with effect on maternal child-care practices and mental health.
Methods:
Randomly selected 2 groups will be identified as intervention and control (150 mothers' from15 clusters in each group). Mothers of 8-23 months old children living in slums and practice harsh child-disciplining will be identified as study population. The mothers of intervention (ECD+HN) group will receive fortnightly group sessions for 11 months that will include combined messages on a) psycho-social stimulation, b) positive parenting to prevent child maltreatment and c) cognitive behavioral therapy (CBT) for positive thinking, d) health and nutrition messages and e) 15 micro-nutrient sprinkle supplement.(90 sachets of over 6 month-period). The control group will only receive the usual health messages provided by the government.
Outcome measures/variables:
- Children's cognitive, motor, language and socio-emotional development; anthropometry; hemoglobin and micro-nutrient status (serum vitamin B12, iron and folic acid)
- Mother s' parenting practices, depressive symptoms, self-esteem and child-maltreatment.
详细描述
Hypothesis to be tested:
This integrated intervention will a) improve children's growth, hemoglobin, micro-nutrient status (vitamin B12 and folic acid), cognitive, motor, language and social-emotional development, b) minimize maltreatment of children by parents, c) improve positive parenting and d) reduce mothers' stress and depressive symptoms compared to control group.
Objectives:
Primary: This integrated intervention will
- Improve cognitive, motor, language and social-emotional development of children
- Minimize maltreatment of children by the caregivers
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 8 Months 至 23 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Mothers of 8 to 23 months old children, who practice maltreatment or harsh child-discipline (screened by a previously used tool), will be included.
- •Children 8-23 months old with weight-for-length ≥-3 z score, MUAC ≥ 115 mm
- •Mothers are the primary caregivers and consented to participate.
排除标准
- •severe malnutrition nutritional edema, known developmental disability, chronic illness, haemoglobin level <8 gm/L (at enrolment). They will be referred to the nearby health facilities for necessary clinical management
研究组 & 干预措施
ECD+
Behavioral: Psychosocial stimulation, Cognitive behavioral therapy and positive parenting practice The mothers of intervention (ECD+HN) group will receive fortnightly group sessions for 12 months that will include combined messages on a) psychosocial stimulation, b) positive parenting to prevent child maltreatment and c) cognitive behavioural therapy (CBT) for positive thinking, d) health and nutrition messages and e) 15 micronutrient sprinkle supplement.(90 sachets of over 6 month-period)
干预措施: Psychosocial stimulation, Cognitive behavioral therapy and positive parenting practice (Behavioral)
Only regular health messages
Only regular health message from government health services
结局指标
主要结局
Cognitive development (composite score of cognitive,motor, language and social-emotional development of children)
时间窗: Change from baseline at 11 months of intervention
cognitive development will be measured by Bayley tools. All individuals score will be aggregated in to composite score of cognitive,motor, language and social-emotional development of children
次要结局
- Maltreatment of children by the caregivers(Change from baseline at 11 months of intervention)
- Height(Change from baseline at 11 months of intervention)
- Weight(Change from baseline at 11 months of intervention)
- Head circumference(Change from baseline at 11 months of intervention)
- Haemoglobin(Change from baseline at 11 months of intervention)
- vitamin B12(Change from baseline at 11 months of intervention)
- folic acid status(Change from baseline at 11 months of intervention)
- Retinol(Change from baseline at 11 months of intervention)
- STfR per Mg/ml(Change from baseline at 11 months of intervention)
- Mothers' stress and depressive symptoms(Change from baseline at 11 months of intervention)
- Positive parenting practices,(Change from baseline at 11 months of intervention)