Effects of Adding Psychosocial Stimulation for Children of Lactating Mothers Enroled to Receive Unconditional Cash Transfer (UCT) and Health Education Awareness Programme on Children's Cognition and Behaviour in Rural Bangladesh
试验速览
- 阶段
- 不适用
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Child development composite score
研究概览
简要总结
Burden: In developing countries, an estimated 219 million children do not reach their maximum potentiality because of poverty and associated risk factors. More than half of the Bangladeshi children <5 years are at risk for developmental delay due to poverty and sub-optimal home stimulation. Sometimes poor people become poorer due to catastrophic expenditure on health care and fall into the vicious cycle of poverty
Knowledge gap: Although, there is evidence that conditional cash transfer helps develop poor people' health and nutritional status, little is known about the effect of unconditional cash transfer and health education (HE) programmes along with psychosocial stimulation on children' cognition and behaviour.
Relevance: The study will bring an opportunity to evaluate the effect of transferring unconditional cash and health education programme along with psychosocial stimulation to poor families under safetynet programme of Bangladesh Govt. in rural areas. The study will also document direct and indirect cost to measure cost effectiveness that will help in decision making to implement the project if it shows benefits to children's development.
Primary Hypothesis (if any):
- Unconditional cash transfer (UCT) and health education (HE) programme will improve child's cognitive, motor and language development and behaviour compared to no intervention group.
- Adding psychosocial stimulation to an unconditional cash transfer (UCT) and health education (HE) programme will will have an additive effect on Childs's cognitive, motor and language development and behaviour compared to the control groups
Secondary Hypothesis:
Additionally the intervention will
- be cost effective,
- reduce mothers' depressive symptoms and improve their self esteem
- improve children's growth and household food security status
- reduce domestic violence
- Health seeking behaviour and health care expenditure
Long-term goal: our ultimate goal is to find a suitable infrastructure to take to scale early child development activities for the whole country.
Methods: It is a Cluster Randomized Controlled Trial with three-arms (i) UCT+HE+Psychosocial stimulation (ii) UCT+HE and iii) Comparison group.
详细描述
Primary objectives:
To evaluate the effect of UCT and HE programme on children's cognitive, motor and language development and behaviour To evaluate the effect of adding psycho social stimulation to an UCT and HE program on cognitive development and behavior of young children
Secondary objectives are:
To measure effect of the program on:
cost effectiveness of the intervention mothers'mental health (depression symptoms) and their self esteem household food security status and children's growth and domestic violence health care expenditure and health seeking behaviour of the families
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
- Single (Outcomes Assessor)
盲法说明
The testers of the participants will not have the information about type of intervention of the children
入排标准
- 年龄范围
- 6 Months 至 16 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Mothers with a child aged 6-16 months
- •Eligible to receive UCT.
- •UCT+HE+PS arm: Receiving unconditional cash from government
- •UCT+HE arm: Receiving unconditional cash from government
- •Comparison arm: eligible to receive UCT but not under UCT programme.
- •Not expected to leave the study site for more than 2 months
- •Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf.
排除标准
- •Legal guardian unwilling or unable to provide written informed consent.
- •Known congenital anomaly
- •Developmental disorder or severe developmental delay
- •Not possible to test the child due to physical or behavioral problems
- •Children of multiple birth e.g. twin, triplets
结局指标
主要结局
Child development composite score
时间窗: Change children's cognition, language and motor as composite score after one year intervention
Children's cognition, language and motor as composite score
Children's behavior and composite score
时间窗: Change children's behaviour after one year intervention
Children's behavior will be measured by Wolk's behavior rating scale during bayley
次要结局
- Children's weight(Change children's weight after one year intervention)
- Children's height(Change children's height after one year intervention)
- Family's monthly health seeking behavior(Change family's health seeking behaviour status after one year intervention)
- Mothers' weight(Change mother's weight after one year intervention)
- Family's monthly income(Change family's income status after one year intervention)
- Family's monthly expenditure(Change family's expenditure status after one year intervention)
- Children's Mid Upper Arm circumference (MUAC)(Change children's MUAC after one year intervention)
- Mothers' level of self-esteem(Change mother's level of self esteem after one year intervention)
- Domestic violence (mothers)(Change family's domestic violence status after one year intervention)
- Mothers' height(Change mother's height after one year intervention)
- Mothers' depressive symptom(Change mother's depression status after one year intervention)
- Family's monthly food security status(Change family's food security status after one year intervention)
- Family care indicators (FCI),(Change of FCI after one year intervention)