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

NCT07472699 | Active Not Recruiting

• 1 other identifier: PR-24109
• Study Type: interventional
• Target: 2,400
• Locations: 1 country
• Sites: 1

Brief Summary

Background (brief):

1. 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. 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. 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.
4. 4.To identify the potential strategies to promote the quality and fidelity of the SB3 early childhood parenting programme integrated into government health care services.
5. 5.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.

Conditions

Early Child Brain Development

Outcome Measures

Primary Outcomes (2)

• Cognitive development

  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

  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 Outcomes (6)

• Children's Behavior

  From enrollment to the end of intervention after 6 months

• Children's weight

  From enrollment to the end of intervention after 6 months

• Children's length

  From enrollment to the end of intervention after 6 months

• Home stimulation

  From enrollment to the end of intervention after 6 months

• Maternal knowledge on child caring practices

  From enrollment to the end of intervention after 6 months.

Study Arms (3)

Intervention Arm 1: Stimulation intervnetion

ACTIVE COMPARATOR

Behavioral: Psychosocial stimulation

Intervention Arm 2: New stimulation intervention

EXPERIMENTAL

Behavioral: Combined

Unique control

NO INTERVENTION

Interventions

Psychosocial stimulation BEHAVIORAL

Intervention Arm 1: Pschosocial stimulation intervention using toys made by the programme.

Intervention Arm 1: Stimulation intervnetion

Combined BEHAVIORAL

Intervention Arm 2: Psychosocial stimulation intervnetion using toys made by mothers.

Intervention Arm 2: New stimulation intervention

Eligibility Criteria

• Age: 6 Months - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead

Study Sites (1)

Icddr,B

Dhaka, Bangladesh

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2026
• First Posted: March 16, 2026
• Study Start: August 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 16, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 6 months and ending 3 years after the publication of results
• Access Criteria: Data will be shared upon request as per icddrb data repository criteria

Locations

BA (1)