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Clinical Trial Summary

The goal of this clinical trial is to test the effect of a pre-primary education parent group intervention in children with and without disability in Nepal Bangladesh and Tanzania. The main question it aims to answer are: - What is the impact of a parent group intervention on primary school readiness in children aged 5-6 years old in three LMICs? - What is the feasibility and accessibility of a parent group intervention for these children? Participants will attend parent group sessions every two weeks for a total of 9 sessions. Researchers will compare a control group to see if there are impacts on school readiness and child development.


Clinical Trial Description

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 is 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. EN-REACH is a cRCT with 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 (MELQO) 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 RE-AIM framework. This trial focused on enhancing school readiness and cognitive abilities in young children, inclusive of those with disabilities, aims 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06334627
Study type Interventional
Source London School of Hygiene and Tropical Medicine
Contact
Status Active, not recruiting
Phase N/A
Start date May 3, 2022
Completion date September 15, 2024

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