NCT06890156

Brief Summary

The goal of the project is to assess the scale-up of the program, focusing on improving school readiness among preschool children, enhancing capacity building for parents and teachers, and utilizing a cluster randomized controlled trial (cRCT). The primary research questions are to seek answer-

  • What specific adaptations are necessary for an innovative, disability-inclusive early education training program to become a fully inclusive model that enhances teachers' engagement and practices in pre-primary classrooms in Nepal, Tanzania, and Bangladesh?
  • How can a new, equitable 'School Readiness Programme for the child-parent-teacher triad' be effectively scaled within national government pre-primary platforms using a cRCT?
  • How can the outcomes of the 'School Readiness Programme for the child-parent-teacher triad' be implemented in a cost-effective manner by key stakeholders across the three sites? The research will examine an adapted inclusive early education training programme will lead to improved teaching practices, enhanced parental capacity, and better school readiness for all children compared to standard education programme; and b) the child-parent-teacher triad model can be scaled effectively within the government primary education systems.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for not_applicable

Timeline
10mo left

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress51%
Jul 2025Mar 2027

First Submitted

Initial submission to the registry

March 17, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 21, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

June 26, 2025

Status Verified

May 1, 2025

Enrollment Period

1.1 years

First QC Date

March 17, 2025

Last Update Submit

June 22, 2025

Conditions

Keywords

School readinessEarly childhood care and education (ECCE)Early childhood development (ECD)Pre-primary educationdisabilitiesCluster randomized controlled trial (cRCT)

Outcome Measures

Primary Outcomes (1)

  • Measuring Early Learning Quality and Outcomes (MELQO)

    School readiness (per-literacy, numeracy, executive functions, and social-emotional learning) will be assessed using the Measuring Early Learning Quality and Outcomes (MELQO)

    40 Minutes

Secondary Outcomes (8)

  • Early childhood version of Home Observation for Measurement of Environment

    30 Minutes

  • Pediatric Quality of Life Inventory (PedsQL)

    30 Minutes

  • Measure of Early Learning Environment (MELE)

    90 minutes

  • Feeling Questionnaires

    5 minutes

  • Teacher Interview Report

    20 minutes

  • +3 more secondary outcomes

Study Arms (2)

Arm 1: Intervention

ACTIVE COMPARATOR

Caregivers and their pre-school children aged 48-84 months, enrolled in pre-primary education.

Behavioral: ENREACH child-parent-teacher triad

Arm 2: Control

NO INTERVENTION

Caregivers and their children aged 48-84 months, enrolled in pre-primary education.

Interventions

Prior to enrolling study participants, we will conduct sensitization meetings with each selected government primary school. These meetings will be oriented toward community leaders, caregivers of children with or without disabilities, and school management committees to introduce them to the program, ensure the inclusion of all children, and address concerns related to gender, poverty, and disability. A disability-inclusive module will be delivered to preschoolers in their regular pre-primary classrooms by trained pre-primary teachers. This module will cover foundational skills, the importance of play, communication, socio-emotional learning, and strategies for adapting the curriculum to accommodate children with disabilities. ENREACH parent group school readiness intervention package will be provided to parents during monthly parent-teacher meetings, facilitated by trained preschool teachers.

Arm 1: Intervention

Eligibility Criteria

Age48 Months - 84 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • All children aged 48-84 months
  • Enrolled in preschools
  • Residing in the catchment areas of GPS
  • Include/over sample for children with functional disabilities even if they are over 84 months of age.

You may not qualify if:

  • Un-consenting parents
  • Intervention school of EN-REACH study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)

Dhaka, 1212, Bangladesh

Location

Related Publications (3)

  • Davis, D., Miller, D., Mrema, D., Matsoai, M., Mapetla, N., Raikes, A., & Burton, A. (2021). Understanding perceptions of quality among early childhood education stakeholders in Tanzania and Lesotho: A multiple qualitative case study. Social Sciences & Humanities Open, 4(1), 100153.

    BACKGROUND
  • Miah MAA, Chandna J, Gurung R, Masoud NS, Paul P, Ameen S, Basnet O, Miraji M, Tann C, Mili IA, Hossain AKMT, Chowdhury AI, Alam A, Milner KM, Arifeen SE, Kc A, Manji K, Lynch P, Lawn JE, Hamadani JD; EN-REACH collaborative group. Every Newborn-Reach Up Early Education Intervention for All Children (EN-REACH)- a parent group intervention for school readiness in Bangladesh, Nepal, and Tanzania: study protocol for a cluster randomized controlled trial. Trials. 2024 Aug 23;25(1):556. doi: 10.1186/s13063-024-08381-6.

    PMID: 39180108BACKGROUND
  • Bangladesh Bureau of Statistics (BBS) and UNICEF, Multiple Indicator Cluster Survey-2019. 2019

    BACKGROUND

Study Officials

  • Jena Derakhshani Hamadani, PhD

    International Centre for Diarrhoeal Disease Research, Bangladesh

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jena Derakhshani Hamadani, PhD

CONTACT

Mohammad Abdul Awal Miah, M.Phil

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
All assessors will be blinded to the intervention group
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prior to enrolling study participants, we will conduct sensitization meetings with each selected government primary school. These meetings will be oriented toward community leaders, caregivers of children with or without disabilities, and SMCs to introduce them to the programme, ensure the inclusion of all children, and address concerns related to gender, poverty, and disability. A disability-inclusive module will be delivered to preschoolers in their regular pre-primary classrooms by trained pre-primary teachers. This module will cover foundational skills, the importance of play, communication, socio-emotional learning, and strategies for adapting the curriculum to accommodate children with disabilities. Additionally, the ENREACH parent group school readiness intervention package will be provided to parents during monthly parent-teacher meetings, facilitated by trained preschool teachers.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2025

First Posted

March 21, 2025

Study Start

July 1, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

March 1, 2027

Last Updated

June 26, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

The investigators have a six-year track record of equitable partnership between sites (Nepal, Bangladesh, Tanzania and London School of Hygiene \& Tropical Medicine) with data sharing agreements already in place. The data will be owned by each country institution and pooled data by the study team. We have already established small committees which include the Principle Investigator (PI) and each site PI who will review any requests for data beyond the original team e.g. - Doctorate of Philosophy formal data sharing agreements will be signed by both parties. However, we will not share any identifiable related individual participant data with other researchers.

Shared Documents
SAP
Time Frame
From December 2025 until analysis is completed A
Access Criteria
All the PIs of each site and statisticians

Locations