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临床试验/NCT04541069
NCT04541069Unknown不适用

Enhancing Social Communication and Emotional Development in Under 5 Children: Intervention Strategies for Inclusive Child Care Practices in Bangladesh.

Centre for Injury Prevention and Research Bangladesh0 个研究点目标入组 2,004 人开始时间: 2021年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
2,004
主要终点
ASQ score (Ages and stages questionnaire) score

研究概览

简要总结

In the United Nation's Sustainable Development Goals (SDGs), the conversation has shifted from the complexity of ensuring decrease in infant mortality to that of holistic wellbeing of children from conception onwards by ensuring early learning opportunities along with nutrition, security and safety. About 13 - 23 percent children in Bangladesh present symptoms of diagnosable and preventable mental health conditions in early childhood. The aim of this effectiveness-implementation hybrid type 2 cluster randomized trial is to implement training program to enhance parental understanding of child's social communication and emotional development, ways to support positive behavior management skills, and to enhance parents' cognizance about when professional help may be sought. Shuchona Foundation's module-based training manual on Social Communication and Emotional Skill Development (SCESD) is designed to sensitize and educate parents/ caregivers on child development. This module will be implemented in Sonargaon, Gojaria and Raiganj Upazilas. The administrative wards in the unions will serve as clusters for the study's first phase. The first phase of six months duration will explore qualitatively the adaptability of existing health system, train field level health workers, training of the data collectors on administering Ages and Stages Questionnaire (ASQ), enrol mothers for equipping them with knowledge and skill to stimulate Early Childhood Development (ECD) and identify delayed childhood development, followed by assessment of ability of mothers to note secondary outcomes or delay at the earliest. The sessions for mother will be conducted using the existing health system of Bangladesh.

A mixed-methods approach comprising of process mapping, qualitative and quantitative data analyses will be used to assess implementation of the intervention with focus on identifying failures in implementation, why they exist and how to reduce them for future implementation and scale-up.

详细描述

  1. Introduction The last five years have witnessed a plethora of literature on early childhood development, the first 1000 days in infancy, and holistic wellbeing of children from conception onwards. In large part due to the United Nation's Sustainable Development Goals (SDGs), the conversation has shifted from the complexity of ensuring decrease in infant mortality to that of ensuring nutrition, prenatal health care, security and safety, early learning opportunities all of which work together to lead to better outcomes for children. This is a significant shift for most low and middle income countries (LMIC's), like Bangladesh, where a well-prepared plan to implement effective programs that are also low-cost and applicable to the existing infrastructure does not exist. According to the Early Childhood Nurturing Care Framework, nutrition, health, early learning, responsive caregiving, security and safety are important components that ensure that countries can achieve their SDG's and thereby enable better outcomes in later childhood and adulthood. 1 In addition, planning for an approach that ensures children at risk for conditions like autism and other developmental disorders are identified sufficiently early in infancy is an added challenge. According to Munir et al (2018), parents in LMIC's rarely reach out to health professionals for behavioral and developmental concerns due to social stigma and lack of evidence-based services, unless their child is experiencing acute medical distress. This in large part explains why, in a country like Bangladesh, which has a comprehensive policy for children, disabilities, health care and nutrition, there still continues to be delay in providing early intervention services and medical services to children with neurodevelopmental disorders.

Figure 1 The nurturing care framework (Wertlieb, 2019) Nurturing care refers to giving children the opportunity to learn in their early childhood years through interactions with peers and adults in a responsive and emotionally supportive environment, which is the result of public policies, programs, and services that include health, nutrition and security. Global research indicates that nearly 385 million children are living in extreme poverty, 155 million children under five have stunted growth, and more than 240 million affected by conflict.2-4 About 300 million children between ages two and four are regularly subjected to violent discipline, including physical punishment and psychological aggression.4 Moreover, around 250 million children (43%) less than 5 years of age in low- and middle-income countries are at risk of not reaching their developmental potential.5 Researches with 0-5-years old indicate that health risks before 24 months impacts mental development of the child. More than 200 million children under 5 years of age are not reaching their developmental potential because of poor health, lack of nutrition and poverty. Medical issues such as delivery by unskilled attendant; infections like malaria and cholera, inadequate nutrition, and inadequate stimulation significantly increase risk for disabilities and reduce the potentiality for greater success in life.6-8 Bangladesh has implemented several programs in order to mitigate the effects of poverty, prenatal and early childhood malnutrition and adverse living conditions. Programs to educate pregnant women, provide health education in communities, adequate vaccinations, stipends and various forms of nutritional programs are currently being provided in many parts of the country through a variety of programs. Nevertheless, according to the recommendations of research in the area of early childhood intervention (EDI) and inclusive early childhood education (IEDE), the most effective programs should encompass both health, learning and stimulation9,10. According to results from the INTERGROWTH-21ST Project, when adequate nutrition and education are given to primary caregivers (mostly mothers) of under two years old children, it accounts for 10% variance in the acquisition of all developmental milestones across all domains, nullifying the supposed effects of cultural child-rearing practices11.

The influence of risk and protective factors cannot be evaluated separately from each other; the balance between the burden experienced by parents, and the capacity and resources of the parents should always be evaluated together.12 A population based study in Bangladesh indicated that 14.6% of children have a diagnosable behavioral impairment13 with a higher prevalence (40.4%) among orphan children.14 Male children were found to be present with increased risk factors.15 A systematic review published in 2014 in Bangladesh indicated that 13.4 to 22.9% children in Bangladesh present symptoms of diagnosable mental health condition.16 Bronfenbrenner17 evidenced that environmental factors play a critical role in coordinating the timing and pattern of gene expression, which in turn determine initial brain architecture. He stated that the development of children is rooted within a bigger context, which includes the characteristics of both the parents and the child, and are a result of constant interaction, as one influences the other: the bioecological model of specific experiences facilitates or inhibit neuronal connectivity at key developmental stages. Our perceptual, cognitive, and emotional capabilities are built upon the platform provided by early life experiences18 It has been evidenced that knowledgeable and skilled parenting can facilitate a supportive relationship and enhance the future positive psychosocial development of the child.12

In the absence of clinically validated biomarkers and the significant variation in the presentation of milder autism cases (typically referred by clinicians as 'high functioning' autism), it is extremely necessary to find a methodology for early detection of risk factors that are easily noticeable by caregivers, coupled with intervention techniques that can be used effectively in the natural environment of the child. The median age of autism diagnosis and intervention in the United States, where tremendous awareness activities are being done, is still at 4.5 years of age. A recent review of the research on when and how parents should be informed about their child's autism diagnosis (See Figure 2) shows that although core areas of deficit in social communication and repetitive stereotypical behaviors do not become apparent till nearly 24 months of age, many early indicators do exist that have been substantiated as prodromal features in the first 6 months 20. And given our understanding of brain plasticity and developmental peaks, there is a strong likelihood that well-trained caregivers can effectively prevent core symptoms of autism from manifesting. At the very least, methods, as prescribed by the Social Communication and Emotional Skill Development (SCESD) manual, could enable a reduced intensity of the delays.

Early identification of developmental disorders is critical to the well-being of children and their families.21 The earlier identification of delay increases the opportunity to provide early intervention, maximizing the benefit of that intervention.22 Thus promoting the development of the child in later years.12 Although evidence shows that early intervention can reduce the impact on the functioning of the child and the family, identification of inadequate social communication and emotional skills in young children has always been a challenging process.22 Family members can play a vital role in the identification and application of the intervention process especially in children under 5 years of age.23 In developing countries with increased child survival, the number of children with social-communication delay is also increasing24. Convention on the Rights of the Child (CRC) and the Convention on the Rights of People with Disabilities (CRPD), both state that children with disabilities have the right to develop to their maximum potential. Investment in Early Childhood Development (ECD), should also focus on children at risk of developmental delays or disabilities24. In a report of the project "Developing an Inclusive Education and ECD Strategy" (2013-2014), Plan Sri Lanka in collaboration with the faculty of medicine university of Kelaniya recommended each early learning activity to be broken down into small steps to support children with delays/ disabilities. It also recommended that the staff/ teachers involved in pre-school cares should be well equipped with the knowledge of screening of early delays/ disabilities.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

When the early childhood development assessment will be done by data collectors through ASQ insruments, they will not be aware of the respondent's status of whether they received the intervention or not.

入排标准

年龄范围
2 Months 至 12 Months(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Mother of children under 2 months of age
  • •Eligible mother who will give consent to participate in the study

排除标准

  • •• Mothers with a critical illness that prevents them to take part in the training sessions or to take care of the child
  • •Families that intend to move out of the area within the study period

研究组 & 干预措施

Social Communication and Emotional Skill Development (SCESD)

Experimental

This arm will get the intervention which is the Early Childhood Development (ECD) training.

干预措施: Social Communication and Emotional Skill Development (SCESD) module (Behavioral)

Control

No Intervention

This arm will not get any intervention.

结局指标

主要结局

ASQ score (Ages and stages questionnaire) score

时间窗: 6 months

To assess the effectiveness of the community centered module-based approach in monitoring social communication and emotional development and those factors which may influence social-emotional development, in infants and young children, this instrument will be used.

次要结局

未报告次要终点

研究者

发起方
Centre for Injury Prevention and Research Bangladesh
申办方类型
Other
责任方
Principal Investigator
主要研究者

Saidur Rahman Mashreky

Professor, Director

Centre for Injury Prevention and Research Bangladesh

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