Early Child Brain DevelopmentECD SB3NCT07472699
Enhancing the Ongoing ECD Scale-up Programme (Saving Bangladeshi Babies Brain (SB3) in Bangladesh
A study testing Psychosocial stimulation and Combined in people with Early Child Brain Development, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Early Child Brain Development
- What is being tested?
- Psychosocial stimulation and Combined
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,400 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 Aug 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Children with MUAC≥13.5 cm
- Those whose parents do not consent to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Extending and Enhancing the Ongoing Early Childhood Development (ECD) Scale-up Programme (Saving Bangladeshi Babies Brain (SB3) in Bangladesh
Background (brief):
- 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.
- 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.
- 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.
Read more
Hypothesis (if any): The Investigators hypothesize that the identified strategies would be effective in improving children's development.
Objectives:
- To identify the potential strategies to promote the quality and fidelity of the SB3 early childhood parenting programme integrated into government health care services.
- 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.
- Conditions
- Early Child Brain Development
- Being tested
- Psychosocial stimulation, Combined
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychosocial stimulationBehavioural
Intervention Arm 1: Pschosocial stimulation intervention using toys made by the programme.
CombinedBehavioural
Intervention Arm 2: Psychosocial stimulation intervnetion using toys made by mothers.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm 1: Stimulation intervnetion | Active comparator | Not described Receives: Behavioral: Psychosocial stimulation |
| Intervention Arm 2: New stimulation intervention | Experimental | Not described Receives: Behavioral: Combined |
| Unique control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From enriollment to after 6 months intervention.
Secondary outcomes (6)
Children's Behavior
Children's behavior will be assessed using the Wolke's Behavior Rating Scale during the cognitive and language assessment period.
Measured: From enrollment to the end of intervention after 6 months
Children's weight
Weight measurement in Kg
Measured: From enrollment to the end of intervention after 6 months
Children's length
Length in Cm
Measured: From enrollment to the end of intervention after 6 months
Home stimulation
Children's home stimulation will be assessed using Family Care Indicator (FCI)
Measured: From enrollment to the end of intervention after 6 months
Maternal knowledge on child caring practices
Maternal knowledge on child caring practices will be assessed using a structured questionnaire.
Measured: From enrollment to the end of intervention after 6 months.
Maternal depression
Maternal depressive symptoms will be assessed using the shortened version Centre for Epidemiological Studies-Depression scale
Measured: From enrollment to the end of intervention after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start1 Aug 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Child Brain DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 2,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07472699
- Sponsor's protocol ID
- PR-24109
- Acronym
- ECD SB3
- Status last verified
- Dec 2025
- First submitted
- 18 Jan 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participants ID, Age, Sex, Socio-economic and demographic information, Treatment group code
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extending and Enhancing the Ongoing Early Childhood Development (ECD) Scale-up Programme (Saving Bangladeshi Babies Brain (SB3) in Bangladesh
- ClinicalTrials.gov ID
- NCT07472699
- Acronym / sponsor ID
- ECD SB3 / PR-24109
- Conditions
- Early Child Brain Development
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,400 participants (actual)
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, BangladeshUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background (brief):
- 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.
- 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.
- 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:
- To identify the potential strategies to promote the quality and fidelity of the SB3 early childhood parenting programme integrated into government health care services.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm 1: Stimulation intervnetion | Active comparator | Behavioral: Psychosocial stimulation |
| Intervention Arm 2: New stimulation intervention | Experimental | Behavioral: Combined |
| Unique control | No intervention | – |
Who may qualify
- Ages
- 6 to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Children with MUAC≥13.5 cm
- Those whose parents do not consent to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychosocial stimulationIntervention Arm 1: Pschosocial stimulation intervention using toys made by the programme. | Behavioural | Intervention Arm 1: Stimulation intervnetion |
| CombinedIntervention Arm 2: Psychosocial stimulation intervnetion using toys made by mothers. | Behavioural | Intervention Arm 2: New stimulation intervention |
Primary outcome
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.
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.
6 secondary outcomes
Children's Behavior
Time frame: 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
Children's length
Time frame: From enrollment to the end of intervention after 6 months
Home stimulation
Time frame: 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 depression
Time frame: From enrollment to the end of intervention after 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: Yes. Participants ID, Age, Sex, Socio-economic and demographic information, Treatment group code
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychosocial stimulation and Combined in people with Early Child Brain Development, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive development (time frame: From enrollment to the end of intervention after 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.