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

Child Development Clinical Trial

— EN-REACH  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06334627
• Other study ID #: ENREACH
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 3, 2022
• Est. completion date: September 15, 2024

Study information

• Verified date: February 2024
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1651
• Est. completion date: September 15, 2024
• Est. primary completion date: April 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Child Development
• Child Development Disorder
• Developmental Disabilities

Intervention

Behavioral:
• Pre-Primary Intervention
School readiness intervention

Locations

Country	Name	City	State
Bangladesh	International Centre for Diarrheal Disease Research, Bangladesh	Dhaka
Nepal	Golden Community	Lalitpur
Tanzania	Muhimbili University of Health and Allied Sciences	Dar Es Salaam

Sponsors (5)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine	Golden Community, Nepal, International Centre for Diarrhoeal Disease Research, Bangladesh, Muhimbili University of Health and Allied Sciences, University of Glasgow

Countries where clinical trial is conducted

Bangladesh,  Nepal,  Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measuring Early Learning Quality and Outcomes (MELQO Tool)	School Readiness	Baseline (children are aged 5-5.5 years) and 6 months later post intervention (children aged 5.5-6 years)
Primary	The Pediatric Evaluation of Disability Inventory	Child Disability	Baseline (children are aged 5-5.5 years) and 6 months later post intervention (children aged 5.5-6 years)
Secondary	Washington Group Questionnaire	Child functioning	Baseline (children are aged 5-5.5 years) and 6 months later post intervention (children aged 5.5-6 years)
Secondary	The Wechsler Preschool & Primary Scale of Intelligence	Child IQ	Baseline (children are aged 5-5.5 years) and 6 months later post intervention (children aged 5.5-6 years)
Secondary	Pre-school Register	Pre-school attendance	Baseline (children are aged 5-5.5 years) and 6 months later post intervention (children aged 5.5-6 years)
Secondary	Mental Health Questionnaire	Maternal Mental Health screen	Baseline (children are aged 5-5.5 years) and 6 months later post intervention (children aged 5.5-6 years)
Secondary	Pediatric Quality of Life Inventory (PEDSQL Tool)	Child and family quality of life	Baseline (children are aged 5-5.5 years) and 6 months later post intervention (children aged 5.5-6 years)