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临床试验/NCT07472699
NCT07472699进行中(未招募)不适用

Extending and Enhancing the Ongoing Early Childhood Development (ECD) Scale-up Programme (Saving Bangladeshi Babies Brain (SB3) in Bangladesh

International Centre for Diarrhoeal Disease Research, Bangladesh1 个研究点 分布在 1 个国家目标入组 2,400 人开始时间: 2024年8月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
2,400
试验地点
1
主要终点
Cognitive development

研究概览

简要总结

Background (brief):

  1. Burden: Globally 250 million children under 5 years of age in developing countries do not reach their full potential due to poverty, malnutrition, and lack of a stimulating environment.
  2. Knowledge gap: The early childhood intervention curriculum 'Reach up & Learn' has been adapted for Bangladesh and were successfully used in 10 trials including two trials integrated with Primary Health Care (PHC) services implemented in Community Clinics. Based on the success of the last two studies, the current programme 'Saving Bangladeshi Babies Brains (SB3)' is conducted in 4 districts. Under this programme, a small cluster randomised controlled trial (cRCT) was conducted and found no benefit on child development. However, the programme involved implementation challanges. Therefore, there is a need to determine the strategies to mitigate the challenges and conduct another round of cRCT to test the effectiveness of the strategies on the child development outcomes.
  3. Relevance: Bangladesh Govt acknowledges the need for improving children's development and has agreed to collaborate and implement early childhood development (ECD) activities at large scale.

Hypothesis (if any): The Investigators hypothesize that the identified strategies would be effective in improving children's development.

Objectives:

  1. To identify the potential strategies to promote the quality and fidelity of the SB3 early childhood parenting programme integrated into government health care services.
  2. To measure the effectivity of the intervnetion on the cogntion, langauge, motor development, and beahvior of the children and maternal parenting knowledge and quality of stimulation at home.

Methods: A mixed-method data collection has been conducted and three potential strategies were identified: raising community awareness, increasing health worker's motivation to deliver a quality programme, and the revised curriculum by replacing mothers' made toys to the supplied toys from the progarmme. These startegies will be piloted. And based on the pilot findings, two strategies will be selected to test the effectiveness on child development using a cluster randomised controlled trial design. In the cluster RCT, there will be two arms : i) intervnetion arm I: regular curriclum, ii) intervnetion arm II: revised curriculum and iii) Unique control. Twenty unions from each programme running district will be randomly selected and then randomly allocated to intervention arm I & II . A four non-programme running districts located at the border of the programme districts will be selected as unique control. The children will be tested at the beginning and the end of the 6 months of intervention.

Outcome measures/variables: The primary outcomes are children's cognition, and language development and the secondary outcomes are children's behaviour and growth, maternal knowledge on child care and their practices, home stimulation and maternal depressive symptoms.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
6 Months 至 24 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Moderately and severely malnourished children aged 6-24 months of both sexes and whose parents agree to participate in the programme.
  • Mid-upper arm circumference (MUAC)<13.5cm will be used to define malnutrition
  • Maternal education qualification less than 8th grade
  • Monthly family income BDT<15000

排除标准

  • Children with MUAC≥13.5 cm
  • Those whose parents do not consent to participate

研究组 & 干预措施

Intervention Arm 1: Stimulation intervnetion

Active Comparator

干预措施: Psychosocial stimulation (Behavioral)

Intervention Arm 2: New stimulation intervention

Experimental

干预措施: Combined (Behavioral)

Unique control

No Intervention

结局指标

主要结局

Cognitive development

时间窗: From enrollment to the end of intervention after 6 months

The primary outcomes are children's cognition, which will be assessed using the psychometric tool named "Bayley Scale of Infant and Toddler Development Version-IV'. The cognition scales include a series of developmental play tasks based on different abilities like memory, problem solving skill, number concepts, etc.

Language

时间窗: From enriollment to after 6 months intervention.

Children's language will be assessed using the psychometric tool named "Bayley Scale of Infant and Toddler Development Version-IV'. Language subscale contains two components: receptive and expressive test.

次要结局

  • Children's Behavior(From enrollment to the end of intervention after 6 months)
  • Children's weight(From enrollment to the end of intervention after 6 months)
  • Children's length(From enrollment to the end of intervention after 6 months)
  • Home stimulation(From enrollment to the end of intervention after 6 months)
  • Maternal knowledge on child caring practices(From enrollment to the end of intervention after 6 months.)
  • Maternal depression(From enrollment to the end of intervention after 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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