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Clinical Trials/NCT06334627
NCT06334627
Active, Not Recruiting
N/A

Every Newborn-Reach Up Early Education Intervention for All Children- a Parent Group Intervention for School Readiness in Bangladesh, Nepal, and Tanzania

London School of Hygiene and Tropical Medicine3 sites in 3 countries1,651 target enrollmentMay 3, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Child Development
Sponsor
London School of Hygiene and Tropical Medicine
Enrollment
1651
Locations
3
Primary Endpoint
The Pediatric Evaluation of Disability Inventory
Status
Active, Not Recruiting
Last Updated
2 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
May 3, 2022
End Date
September 15, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Children aged 4-6 years in study area
  • Children who completed previous EN-SMILING Study

Exclusion Criteria

  • Children outside of age range
  • Children living outside of study area

Outcomes

Primary Outcomes

The Pediatric Evaluation of Disability Inventory

Time Frame: Baseline (children are aged 5-5.5 years) and 6 months later post intervention (children aged 5.5-6 years)

Child Disability

Measuring Early Learning Quality and Outcomes (MELQO Tool)

Time Frame: Baseline (children are aged 5-5.5 years) and 6 months later post intervention (children aged 5.5-6 years)

School Readiness

Secondary Outcomes

  • Pre-school Register(Baseline (children are aged 5-5.5 years) and 6 months later post intervention (children aged 5.5-6 years))
  • Washington Group Questionnaire(Baseline (children are aged 5-5.5 years) and 6 months later post intervention (children aged 5.5-6 years))
  • The Wechsler Preschool & Primary Scale of Intelligence(Baseline (children are aged 5-5.5 years) and 6 months later post intervention (children aged 5.5-6 years))
  • Mental Health Questionnaire(Baseline (children are aged 5-5.5 years) and 6 months later post intervention (children aged 5.5-6 years))
  • Pediatric Quality of Life Inventory (PEDSQL Tool)(Baseline (children are aged 5-5.5 years) and 6 months later post intervention (children aged 5.5-6 years))

Study Sites (3)

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