背景:弱势儿童,包括那些有神经发育迟缓和残疾的人,在获得早期初等教育方面经常面临障碍,从而阻碍了可持续发展目标4.2的进展。循证干预措施对于增强包容性和建立可持续的实施战略以应对这一挑战至关重要。这项研究,每个新生儿-对所有儿童进行早期教育干预(EN-REACH),建立在以前的每一个新生儿-简化测量整合纵向神经发育和生长(EN-SMILING)观察性队列研究的基础上。本文提供了一项集群随机对照试验(cRCT)的方案,以评估育儿小组干预计划在孟加拉国提高学校准备程度的有效性。尼泊尔,坦桑尼亚,和嵌入式过程评估,以告知可扩展性和可行性。
方法:EN-REACH是一种cRCT,具有至少150个集群,用于评估由受过培训的家长-教师主持人对领导的家长培训计划的影响,专注于4~6岁的儿童,为学龄前做准备。已经确定了来自每个站点的EN-SILING队列的大约500名参与者。地理信息系统将在这三个国家中的每个国家定义约50个集群,每个都有大约十个父子二元。一半的集群将被随机分配到干预组和对照组。主要结果是“学校准备”,使用测量早期学习质量和结果工具进行评估。次要结果包括智商,儿童功能,增长,视觉,和听力评估。数据将在基线时收集,以及实施父母组干预会议后约5个月的干预后数据。关于覆盖率和质量护理的定量数据,结合儿童的定性见解,看护者,主持人,和利益相关者的观点,将用于进行应用范围的过程评估,有效性,收养,实施,和维护(RE-AIM)框架。讨论:该协议详细介绍了一项旨在提高幼儿入学准备和认知能力的试验,包括残疾人,旨在弥合从家庭到早期初等教育的差距。EN-REACH旨在深入了解在三个国家共同设计的包容残疾的学校准备计划的有效性和可接受性。可能影响所有儿童的国家和全球政策,包括残疾人。
背景:该试验于2024年2月29日在clinicaltrials.gov上进行了回顾性注册(NCT06334627)。
BACKGROUND: Vulnerable children, including those with neuro-developmental delays and disabilities, often face barriers in accessing early primary education, thus hindering progress toward Sustainable Development Goal 4.2. Evidence-based interventions are essential to enhancing inclusivity and establishing sustainable implementation strategies to address this challenge. This study, Every Newborn-Reach up Early Education Intervention for All Children (EN-REACH), builds on the previous Every Newborn- Simplified Measurement Integrating Longitudinal Neurodevelopmental and Growth (EN-SMILING) observational cohort study. This paper provides the protocol for a cluster randomized controlled trial (cRCT) to evaluate the effectiveness of a parenting group intervention program for enhancing school readiness in Bangladesh, Nepal, and Tanzania, and an embedded process evaluation to inform scalability and feasibility.
METHODS: EN-REACH is a cRCT with at least 150 clusters to evaluate the impact of a parent training program led by trained parent-teacher facilitator pairs, focusing on children aged 4 ~ 6 years preparing for preschool. Approximately 500 participants from the EN-SMILING cohort at each site have been identified. A geographic information system will define ~ 50 clusters in each of the three countries, each with approximately ten parent-child dyads. Half the clusters will be randomly assigned to intervention and control groups. The primary outcome is \"school readiness\", assessed using the Measuring Early Learning Quality and Outcomes tool. Secondary outcomes include Intelligence Quotient, child functioning, growth, visual, and hearing assessments. Data will be collected at baseline, and post-intervention data following implementation of the parent group intervention sessions over approximately 5 months. Quantitative data on coverage and quality care, combined with qualitative insights from children, caregivers, facilitators, and stakeholders\' perspectives, will be used to conduct a process evaluation applying the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. DISCUSSION: This protocol details a trial focused on enhancing school readiness and cognitive abilities in young children, inclusive of those with disabilities, aiming to bridge gap from home to early primary education. EN-REACH aims to provide insights into the effectiveness and acceptability of a co-designed disability-inclusive school readiness program in three countries, potentially impacting national and global policies for all children, including those with disabilities.
BACKGROUND: The trial was retrospectively registered on clinicaltrials.gov on 29 February 2024 (NCT06334627).