Evaluating Effects of Integrating ECD Activities Into Bangladesh Government's Urban Lactating Mothers Allowance Program for the Poor on Children's Cognition and Behaviour in Rangpur City Corporation, Bangladesh
试验速览
- 阶段
- 不适用
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Children's cognitive composite score ranging from 55 to 145 using Bayley Scales of Infant and Toddler Development (Bayley-III)
研究概览
简要总结
Burden:
Provision of health care to urban poor population is a great challenge because of supply and demand barriers in the urban health system, which is considered patchy and fragmented. The poor urban people, especially mothers have little access to government health facilities. The health care platform is not well designed in primary health care delivery for urban health system but presently almost 30 percent people are living in urban area of the country.
Knowledge gap:
Little is known about what happen if psycho social stimulation is provided using urban lactating allowance program on children's cognition and behavior. There is little information about nature and bottleneck of Early Childhood Development (ECD) activities available in the urban Bangladesh.
Relevance:
This is an opportunity to develop a combined package integrating psycho social stimulation with the existing urban lactating allowance program on disadvantaged children's development.
As the urban health system is complex, patchy and fragmented, prior to this intervention An analysis will be done on ECD services and its bottleneck in urban area through Tanahashi framework.
Hypothesis (if any):
Adding psycho social stimulation to urban lactating allowance program will have additional effect on children's cognitive, motor and language development and behavior compared to the comparison group
Secondary Hypothesis:
Additionally the intervention will- improve mothers' quality of life and reduce their depressive symptoms be cost effective,
Objectives:
- To evaluate the effect of integrated urban lactating allowance and psycho social stimulation on children's cognitive, motor and language development and behavior
- To measure nature and bottleneck of ECD services in urban Bangladesh
Secondary objectives:
To measure effect of the programs on:
- mothers' quality of life and mental health (depression symptoms)
- cost effectiveness of the intervention
Methods: A two-arm, Cluster Randomized Controlled Trial: i) Lactating allowance + Psycho social stimulation; (ii) Only lactating allowance
Outcome measures/variables: Children's cognitive, motor and language development measured on Bayley-III, behavior on Wolke's rating scales, Mother's quality of life and depressive symptoms , household food security status, socioeconomic status, quality of home stimulation using family care indicators, Mother's knowledge on child care and development, children's growth measured by length/height, weight and head circumference,mothers' height, weight and mid upper arm circumference, direct and indirect cost of the project.
详细描述
It is estimated that 250 million children do not reach their potential due to poverty, inadequate stimulation and associated risk factors in low and middle income countries.
In Bangladesh more than 50% of children under 5 years are at risk of developmental delay. Urban population is about 28% and it is expected to rise to more than 40% by 2030. In fact, urbanization in Bangladesh is rapidly growing but is not well planned. Poor urban women and children are vulnerable in terms of health and education .
The urban health care facilities are fragmented and patchy and every year rise in population is putting more pressure on health system. Moreover, there is huge economic disparity between rich and poor in the urban areas and poorer people have little access to health care due to both supply and demand barriers. So the situation is rolling more difficult every day.
Ministry of Women and Children Affairs (MOWCA) has taken initiatives to help urban poor mothers through lactating allowance (LA) and limited health education programs. A study conducted in Zimbabwe documented that unconditional cash transfer showed an increase in receiving children's birth certificate and immunization in the age group of 0-4years and school attendance in 6-12 years. Recent systematic review concluded that unconditional cash transfer may not improve health services use in children and adult in low and middle income countries but may have positive impact on food choices and food security. It is expected that this urban lactating allowance will develop economic capacity of people, empower women, improve their quality of life and reduce gender gap.
Very few ECD programs are available for poor urban children especially for the 1st thousand days. The idea is to develop a combined package integrating psycho social stimulation with the existing urban lactating allowance program and measuring its effects on disadvantaged children's development.
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 Assessor who will measure children's cognitive development and behavor and other measurements will be masked
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
- •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
- •If not possible to test the child due to physical or behavioural problems
- •Children of multiple birth e.g. twin, triplets
结局指标
主要结局
Children's cognitive composite score ranging from 55 to 145 using Bayley Scales of Infant and Toddler Development (Bayley-III)
时间窗: Children's cognitive composite score ranging from 55 to 145 using Bayley Scales of Infant and Toddler Development (Bayley-III) after one year intervention
Children's cognitive composite score ranging from 55 to 145 using Bayley Scales of Infant and Toddler Development (Bayley-III). Higher values represent a better status
Children's language composite score ranging from 45 to 155 using Bayley Scales of Infant and Toddler Development (Bayley-III)
时间窗: Children's language composite score ranging from 45 to 155 using Bayley Scales of Infant and Toddler Development (Bayley-III) after one year intervention
Children's language composite score ranging from 45 to 155 using Bayley Scales of Infant and Toddler Development (Bayley-III). Higher values represent a better status
Children's motor composite score ranging from 45 to 155 using Bayley Scales of Infant and Toddler Development (Bayley-III)
时间窗: Children's motor composite score ranging from 45 to 155 using Bayley Scales of Infant and Toddler Development (Bayley-III) after one year intervention
Children's motor composite score ranging from 45 to 155 using Bayley Scales of Infant and Toddler Development (Bayley-III). Higher values represent a better status
Children's approach behaviour using Wolk's behavior rating scale ranging from 1 to 9
时间窗: Children's approach behaviour using Wolk's behavior rating scale ranging from 1 to 9 after one year intervention
Children's approach behaviour using Wolk's behavior rating scale ranging from 1 to 9 during Bayley. Higher values represent a better status
Children's general emotion tone behaviour using Wolk's behavior rating scale ranging from 1 to 9
时间窗: Children's general emotion tone behaviour using Wolk's behavior rating scale ranging from 1 to 9 after one year intervention
Children's general emotion tone behaviour using Wolk's behavior rating scale ranging from 1 to 9 during Bayley. Higher values represent a better status
Children's vocalization behaviour using Wolk's behavior rating scale ranging from 1 to 9
时间窗: Children's vocalization behaviour using Wolk's behavior rating scale ranging from 1 to 9 after one year intervention
Children's vocalization behaviour using Wolk's behavior rating scale ranging from 1 to 9 during Bayley. Higher values represent a better status
Children's activity behaviour using Wolk's behavior rating scale ranging from 1 to 9
时间窗: Children's activity behaviour using Wolk's behavior rating scale ranging from 1 to 9 after one year intervention
Children's activity behaviour using Wolk's behavior rating scale ranging from 1 to 9 during Bayley. Higher values represent a more active status.
Children's cooperation behaviour using Wolk's behavior rating scale ranging from 1 to 9
时间窗: Children's cooperation behaviour using Wolk's behavior rating scale ranging from 1 to 9 after one year intervention
Children's cooperation behaviour using Wolk's behavior rating scale ranging from 1 to 9 during Bayley. Higher values represent a better status
次要结局
- Children's weight(Change children's weight after one year intervention)
- Mothers' height(Change mother's height after one year intervention)
- Mothers' Mid Upper Arm circumference (MUAC)(Change mother's Mid Upper Arm circumference (MUAC) after one year intervention)
- Children's height(Change children's height after one year intervention)
- Children's Mid Upper Arm circumference (MUAC)(Change children's MUAC after one year intervention)
- Mothers' weight(Change mother's weight after one year intervention)
- Mothers' depressive symptom(Change mother's depression status after one year intervention)
- Mothers' quality of life status(Change mother's quality of life status after one year intervention)
- Family's monthly food security status(Change family's food security status after one year intervention)
- Domestic violence (mothers)(Change family's domestic violence status after one year intervention)
- Family care indicators (FCI)(Change of FCI after one year intervention)
- Mothers' knowledge on parenting(Change of mothers' knowledge after one year intervention)