NCT06334627

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.

Trial Health

58
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,651

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2022

Typical duration for not_applicable

Geographic Reach
3 countries

3 active sites

Status
active not 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 Start

First participant enrolled

May 3, 2022

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

February 29, 2024

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 28, 2024

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2024

Completed
Last Updated

March 28, 2024

Status Verified

February 1, 2024

Enrollment Period

2 years

First QC Date

February 29, 2024

Last Update Submit

March 27, 2024

Conditions

Child DevelopmentChild Development Disorder

Keywords

Child developmentchild disabilitypre-primary educationschool readiness

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • 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)

  • Pre-school Register

    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 Arms (2)

Pre-Primary Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

No intervention delivered. Participants will attend any government pre-primary based programmes as standard of care.

Interventions

Pre-Primary InterventionBEHAVIORAL

School readiness intervention

Pre-Primary Intervention

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

International Centre for Diarrheal Disease Research, Bangladesh

Dhaka, Bangladesh

Location

Golden Community

Lalitpur, Nepal

Location

Muhimbili University of Health and Allied Sciences

Dar es Salaam, Tanzania

Location

Related Publications (1)

  • 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: 39180108DERIVED

MeSH Terms

Conditions

Developmental Disabilities

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental Disorders

Study Officials

  • Joy Lawn, PhD

    London School of Hygiene and Tropical Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 29, 2024

First Posted

March 28, 2024

Study Start

May 3, 2022

Primary Completion

April 15, 2024

Study Completion

September 15, 2024

Last Updated

March 28, 2024

Record last verified: 2024-02

Locations

NE(1)BA(1)TA(1)