Enhancing the Ongoing ECD Scale-up Programme (Saving Bangladeshi Babies Brain (SB3) in Bangladesh (ECD SB3)

March 11, 2026 updated by: International Centre for Diarrhoeal Disease Research, Bangladesh

Extending and Enhancing the Ongoing Early Childhood Development (ECD) Scale-up Programme (Saving Bangladeshi Babies Brain (SB3) in Bangladesh

Background (brief):

  1. Burden: Globally 250 million children under 5 years of age in developing countries do not reach their full potential due to poverty, malnutrition, and lack of a stimulating environment.
  2. Knowledge gap: The early childhood intervention curriculum 'Reach up & Learn' has been adapted for Bangladesh and were successfully used in 10 trials including two trials integrated with Primary Health Care (PHC) services implemented in Community Clinics. Based on the success of the last two studies, the current programme 'Saving Bangladeshi Babies Brains (SB3)' is conducted in 4 districts. Under this programme, a small cluster randomised controlled trial (cRCT) was conducted and found no benefit on child development. However, the programme involved implementation challanges. Therefore, there is a need to determine the strategies to mitigate the challenges and conduct another round of cRCT to test the effectiveness of the strategies on the child development outcomes.
  3. Relevance: Bangladesh Govt acknowledges the need for improving children's development and has agreed to collaborate and implement early childhood development (ECD) activities at large scale.

Hypothesis (if any): The Investigators hypothesize that the identified strategies would be effective in improving children's development.

Objectives:

  1. To identify the potential strategies to promote the quality and fidelity of the SB3 early childhood parenting programme integrated into government health care services.
  2. To measure the effectivity of the intervnetion on the cogntion, langauge, motor development, and beahvior of the children and maternal parenting knowledge and quality of stimulation at home.

Methods: A mixed-method data collection has been conducted and three potential strategies were identified: raising community awareness, increasing health worker's motivation to deliver a quality programme, and the revised curriculum by replacing mothers' made toys to the supplied toys from the progarmme. These startegies will be piloted. And based on the pilot findings, two strategies will be selected to test the effectiveness on child development using a cluster randomised controlled trial design. In the cluster RCT, there will be two arms : i) intervnetion arm I: regular curriclum, ii) intervnetion arm II: revised curriculum and iii) Unique control. Twenty unions from each programme running district will be randomly selected and then randomly allocated to intervention arm I & II . A four non-programme running districts located at the border of the programme districts will be selected as unique control. The children will be tested at the beginning and the end of the 6 months of intervention.

Outcome measures/variables: The primary outcomes are children's cognition, and language development and the secondary outcomes are children's behaviour and growth, maternal knowledge on child care and their practices, home stimulation and maternal depressive symptoms.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Moderately and severely malnourished children aged 6-24 months of both sexes and whose parents agree to participate in the programme.
  • Mid-upper arm circumference (MUAC)<13.5cm will be used to define malnutrition
  • Maternal education qualification less than 8th grade
  • Monthly family income BDT<15000

Exclusion Criteria:

  • Children with MUAC≥13.5 cm
  • Those whose parents do not consent to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention Arm 1: Stimulation intervnetion
Behavioral: Psychosocial stimulation
Intervention Arm 1: Pschosocial stimulation intervention using toys made by the programme.
Experimental: Intervention Arm 2: New stimulation intervention
Behavioral: Combined
Intervention Arm 2: Psychosocial stimulation intervnetion using toys made by mothers.
No Intervention: Unique control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive development
Time Frame: From enrollment to the end of intervention after 6 months
The primary outcomes are children's cognition, which will be assessed using the psychometric tool named "Bayley Scale of Infant and Toddler Development Version-IV'. The cognition scales include a series of developmental play tasks based on different abilities like memory, problem solving skill, number concepts, etc.
From enrollment to the end of intervention after 6 months
Language
Time Frame: From enriollment to after 6 months intervention.
Children's language will be assessed using the psychometric tool named "Bayley Scale of Infant and Toddler Development Version-IV'. Language subscale contains two components: receptive and expressive test.
From enriollment to after 6 months intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Children's Behavior
Time Frame: From enrollment to the end of intervention after 6 months
Children's behavior will be assessed using the Wolke's Behavior Rating Scale during the cognitive and language assessment period.
From enrollment to the end of intervention after 6 months
Children's weight
Time Frame: From enrollment to the end of intervention after 6 months
Weight measurement in Kg
From enrollment to the end of intervention after 6 months
Children's length
Time Frame: From enrollment to the end of intervention after 6 months
Length in Cm
From enrollment to the end of intervention after 6 months
Home stimulation
Time Frame: From enrollment to the end of intervention after 6 months
Children's home stimulation will be assessed using Family Care Indicator (FCI)
From enrollment to the end of intervention after 6 months
Maternal knowledge on child caring practices
Time Frame: From enrollment to the end of intervention after 6 months.
Maternal knowledge on child caring practices will be assessed using a structured questionnaire.
From enrollment to the end of intervention after 6 months.
Maternal depression
Time Frame: From enrollment to the end of intervention after 6 months
Maternal depressive symptoms will be assessed using the shortened version Centre for Epidemiological Studies-Depression scale
From enrollment to the end of intervention after 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

International Centre for Diarrhoeal Disease Research, Bangladesh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

January 18, 2026

First Submitted That Met QC Criteria

March 11, 2026

First Posted (Actual)

March 16, 2026

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • PR-24109

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Participants ID, Age, Sex, Socio-economic and demographic information, Treatment group code

IPD Sharing Time Frame

Beginning 6 months and ending 3 years after the publication of results

IPD Sharing Access Criteria

Data will be shared upon request as per icddrb data repository criteria

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Early Child Brain Development

Clinical Trials on Psychosocial stimulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe