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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Child Development; Child Development Disorder
• Intervention / Treatment: Behavioral: Pre-Primary Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 1651
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pre-Primary Intervention; Program consisting of 9 modules focussing on early learning, play, saftey, wellbeing, reading and writing will be delivered approximately every two weeks to groups of 10 parents from the intervention arm.	Behavioral: Pre-Primary Intervention; School readiness intervention
No Intervention: Control; No intervention delivered. Participants will attend any government pre-primary based programmes as standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: London School of Hygiene and Tropical Medicine
• Collaborators: International Centre for Diarrhoeal Disease Research, Bangladesh; University of Glasgow; Muhimbili University of Health and Allied Sciences; Golden Community, Nepal
• Investigators: Principal Investigator: Joy Lawn, PhD, London School of Hygiene and Tropical Medicine

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2022
• Primary Completion (Estimated): April 15, 2024
• Study Completion (Estimated): September 15, 2024

Study Registration Dates

• First Submitted: February 29, 2024
• First Submitted That Met QC Criteria: March 27, 2024
• First Posted (Actual): March 28, 2024

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Child development; school readiness; child disability; pre-primary education
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Developmental Disabilities
• Other Study ID Numbers: ENREACH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Annonomysed primary outcome data will be made available along with the protocol and statistical analysis plan

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No