Clinical trial NCT06334627: Every Newborn-Reach Up Early Education Intervention for All Children- a Parent Group Intervention for School Readiness in Bangladesh, Nepal, and Tanzania
Official title: Every Newborn-Reach Up Early Education Intervention for All Children- a Parent Group Intervention for School Readiness in Bangladesh, Nepal, and Tanzania
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Child Development
Child Development Disorder
Keywords: Child development
child disability
pre-primary education
school readiness
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: International Centre for Diarrhoeal Disease Research, Bangladesh
name: Golden Community, Nepal
name: Muhimbili University of Health and Allied Sciences
name: University of Glasgow
First posted: 2024-03-28
Enrollment: 1651
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Measuring Early Learning Quality and Outcomes (MELQO Tool)
timeFrame: Baseline (children are aged 5-5.5 years) and 6 months later post intervention (children aged 5.5-6 years)
measure: The Pediatric Evaluation of Disability Inventory
timeFrame: Baseline (children are aged 5-5.5 years) and 6 months later post intervention (children aged 5.5-6 years)
Secondary outcomes:
measure: Washington Group Questionnaire
timeFrame: Baseline (children are aged 5-5.5 years) and 6 months later post intervention (children aged 5.5-6 years)
measure: The Wechsler Preschool & Primary Scale of Intelligence
timeFrame: Baseline (children are aged 5-5.5 years) and 6 months later post intervention (children aged 5.5-6 years)
measure: Pre-school Register
timeFrame: Baseline (children are aged 5-5.5 years) and 6 months later post intervention (children aged 5.5-6 years)
measure: Mental Health Questionnaire
timeFrame: Baseline (children are aged 5-5.5 years) and 6 months later post intervention (children aged 5.5-6 years)
measure: Pediatric Quality of Life Inventory (PEDSQL Tool)
timeFrame: Baseline (children are aged 5-5.5 years) and 6 months later post intervention (children aged 5.5-6 years)
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: International Centre for Diarrheal Disease Research, Bangladesh
city: Lalitpur
country: Nepal
facility: Golden Community
city: Dar Es Salaam
country: Tanzania
facility: Muhimbili University of Health and Allied Sciences
Study officials:
affiliation: London School of Hygiene and Tropical Medicine
name: Joy Lawn, PhD
role: PRINCIPAL_INVESTIGATOR
References: