Child DevelopmentBUDHI/SBBBNCT04093934
Strengthening Bangladeshi Babies Brains (SBBB)
A study testing Psychosocial stimulation in people with Child Development, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
Trial summary
This study aims to establish a sustainable programme whereby early childhood development activities are integrated into the routine activities of community clinics in rural Bangladesh for undernourished children by developing a cascade of training at national, district, Upazila (sub-district), and union level to train… Read more about this study
- Who is it for?
- Ages 6 to 24 months
- Conditions the study is for
- Child Development
- What is being tested?
- Psychosocial stimulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteBangladesh
- Study dates
- Jul 2022to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Child
Who may be able to join
- Moderately and severely malnourished children
- Aged 6-24 mo
- Both sexes
- Mid-upper arm circumference (MUAC)<12.5 cm
- Parents agree to participate in the programme.
Who cannot join
- Children with MUAC≥12.5 cm
- Those whose parents do not consent to participate
- Children with disability, multiple births or any congenital abnormality will be included in the intervention but excluded from the evaluation sample
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site
International Centre for Diarrhoeal Disease Research, Bangladesh
Dhaka, 1212
Jena D Hamadani, PhD, +880-2-9827001 ext. 2350, jena@icddrb.org
Fahmida Tofail, PhD, +880-2-9827001, ftofail@icddrb.org
About this study
Official title: Developing a Sustainable Organizational Structure to Integrate Psychosocial Stimulation Programme Into Primary Health Care Services in Bangladesh [Bangladesh Undertaking Child Development and Health-system Integration (BUDHI) Project]
This study aims to establish a sustainable programme whereby early childhood development activities are integrated into the routine activities of community clinics in rural Bangladesh for undernourished children by developing a cascade of training at national, district, Upazila (sub-district), and union level to train clinic staff.
Read the detailed description
Background (brief):
- Burden: Approximately 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. It is estimated that in Bangladesh 44% of the population live below the international poverty line, and 36% of children under 5 years are stunted. Bangladeshi children showed a significant cognitive deficit as early as 7 months of age compared to more affluent children and the deficit grew bigger as children reached 5 years of age.
- Knowledge gap: Several studies in developing countries have shown benefits of early childhood interventions to development of under-5 children. The curriculum of early childhood intervention 'Reach up' has been adapted for Bangladesh and used in 6 trials in Bangladesh. All the projects found consistent significant benefits on the developmental outcomes of children. Two recent trials were conducted in community clinics (CCs), integrating early childhood development (ECD) activities with Govt primary health service and there is a need to determine if the intervention can be taken to scale.
- Relevance:
Bangladesh Govt acknowledges the need for improving children's development and has agreed to collaborate and implement ECD activities at large scale in addition to funding it.
Hypothesis (if any): We hypothesize that it is feasible to train GoB staff at District, Upazila (Sub-district), Union and CC levels and integrate ECD activities in CCs in Bangladesh and thereby improve undernourished children's development after a year of intervention.
Objectives:
- To establish an organizational structure for the programme to be sustainable
- To establish a mechanism for sustainability at national, district and Upazila levels: including training, supervision, monitoring and reporting
- To assess the impact on maternal knowledge and depressive symptoms, stimulation in the home and child growth, cognition and language in a subsample
Methods: Undernourished children aged 6-24 months will be identified using mid-arm upper circumference (MUAC) by Govt. Health staff in 12 Upazilas of Sylhet and 11 Upazilas of Chittagong Divisions. We target to include 554 Community clinics in the programme and train approx. 1600 CC staff to deliver the parenting session. We will evaluate a subsample of the children through a 'stepped wedge design' to assess the effects of intervention using a cluster randomized controlled trial.
Outcome measures/variables: The main outcomes are coverage, compliance and fidelity of the programme. In addition, children's cognitive and language development and behaviour will be assessed in a sub-sample.
- Conditions
- Child Development
- Being tested
- Psychosocial stimulation
- Keywords
- Early childhood development, Psychosociaal stimulation, Bayley test, Bangladesh, Undernutrition, Stepped wedge design, Cluster randomized controlled trial
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychosocial stimulationBehavioural
Also called Nutritional support
Children will receive fortnightly sessions of psychosocial stimulation and nutritional support for one year during the study period.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Children in the intervention arm will receive sessions of psychosocial stimulation every two weeks at the community clinics for one year. The intervention includes songs, games, book and toy activities for undernourished children and nutritional and developmental messages for their mothers. Receives: Behavioral: Psychosocial stimulation |
| Wait-listed control | No intervention | The wait-listed controls will be only tested at baseline and after a year. Following completion of the 2nd test, they will be included in the study and receive the same intervention provided to children in the experimental arm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function
Cognitive Composite scores on Bayley Scales of Infant and Toddler Development-III test, measuring children's cognition aged 1-42 months, ranging from 55 to 145. Higher values represent better outcome.
Measured: Through study completion, an average of 1 year
Language development
Language Composite scores on Bayley Scales of Infant and Toddler Development-III test, measuring children's language aged 1-42 months, ranging from 47 to 153. Higher values represent better outcome.
Measured: Through study completion, an average of 1 year
Secondary outcomes (8)
Response to examiner
Wolke's Behaviour ratings measuring response to examiner of children aged 1-42 months ranging from 1-9. Higher values represent better outcome.
Measured: Through study completion, an average of 1 year
Emotional Tone
Wolke's Behaviour ratings measuring emotional tone of children aged 1-42 months ranging from 1-9. Higher values represent better outcome.
Measured: Through study completion, an average of 1 year
Cooperation with test procedure
Wolke's Behaviour ratings measuring cooperativeness of children aged 1-42 months ranging from 1-9. Higher values represent better outcome.
Measured: Through study completion, an average of 1 year
Vocalization
Wolke's Behaviour ratings measuring vocalization of children aged 1-42 months ranging from 1-9. Higher values represent better outcome.
Measured: Through study completion, an average of 1 year
Quality of home stimulation
Family Care Indicators (FCI), measuring play activities (ranging from 0-15), play materials (ranging from 0-7), books (ranging from 0-10), and magazines (ranging from 0-10), available to child at home. The sub-scales of play activities, play materials, books and magazines will be summed to make a total FCI score, ranging from 0-42. Higher values represent better outcome.
Measured: Through study completion, an average of 1 year
Anthropometry
WHO standards for measuring weight in kilograms, length/height and head circumference in centimeters. These measures will be converted to Z scores for head-circumference-for-age, weight-for-age, length/height-for-age and weight-for-length/height. Values between - to +1 Z scores represent normal values and increment up to +3 Z score represent improvement. But, values more than +3 Z score are not normal.
Measured: Through study completion, an average of 1 year
Maternal knowledge of child rearing
Pre-designed and previously used questionnaire measuring maternal knowledge of child development, ranging from 0-50. Higher values represent better outcome.
Measured: Through study completion, an average of 1 year
Maternal depressive symptoms
Family Care Indicators measuring 6 depressive symptoms of mothers in days for the last 7 days, ranging from 0-42. Lower values represent better outcome.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2019
- Study startJul 2022 (estimated)
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Child 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
- Parallel groups
- Model description
- 'stepped wedge design'
- Masking
- None (open label)
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Sponsor type
- University, hospital or other
- Collaborators
- Bangor University, Institute of Child Health
- Responsible party
- Sponsor
- Investigators
- Jena D Hamadani, PhD, Principal investigator, International Centre for Diarrhoeal Disease Research, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04093934
- Sponsor's protocol ID
- PR-19040
- Acronym
- BUDHI/SBBB
- Status last verified
- Jan 2022
- First submitted
- 18 Aug 2019
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will not be shared with other researchers in its present form, however, de-identified data may be shared with other researchers if they come up with any novel idea for new analysis.
Publications
Tipu SMMU, Hossain SJ, Arifeen SE, Mehrin SF, Salveen NE, Kawsir M, Bhuiyan MSA, Shiraji S, Hasan MI, Tofail F, Hamadani JD. A sustainable organizational structure to integrate psycho-social stimulation programme into primary health care services in Bangladesh: protocol for a pragmatic cluster randomized controlled trial on scaling up early childhood development activities. BMC Psychol. 2025 May 19;13(1):525. doi: 10.1186/s40359-025-02795-w.
PubMed 40390132
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Sustainable Organizational Structure to Integrate Psychosocial Stimulation Programme Into Primary Health Care Services in Bangladesh [Bangladesh Undertaking Child Development and Health-system Integration (BUDHI) Project]
- ClinicalTrials.gov ID
- NCT04093934
- Acronym / sponsor ID
- BUDHI/SBBB / PR-19040
- Conditions
- Child Development
- Keywords
- Early childhood development, Psychosociaal stimulation, Bayley test, Bangladesh, Undernutrition, Stepped wedge design, Cluster randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, BangladeshUniversity, hospital or other
- Collaborators
- Bangor University, Institute of Child Health
- Study start
- Jul 2022 (estimated)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 18 Sep 2019 (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.
This study aims to establish a sustainable programme whereby early childhood development activities are integrated into the routine activities of community clinics in rural Bangladesh for undernourished children by developing a cascade of training at national, district, Upazila (sub-district), and union level to train clinic staff.
Detailed description
Background (brief):
- Burden: Approximately 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. It is estimated that in Bangladesh 44% of the population live below the international poverty line, and 36% of children under 5 years are stunted. Bangladeshi children showed a significant cognitive deficit as early as 7 months of age compared to more affluent children and the deficit grew bigger as children reached 5 years of age.
- Knowledge gap: Several studies in developing countries have shown benefits of early childhood interventions to development of under-5 children. The curriculum of early childhood intervention 'Reach up' has been adapted for Bangladesh and used in 6 trials in Bangladesh. All the projects found consistent significant benefits on the developmental outcomes of children. Two recent trials were conducted in community clinics (CCs), integrating early childhood development (ECD) activities with Govt primary health service and there is a need to determine if the intervention can be taken to scale.
- Relevance:
Bangladesh Govt acknowledges the need for improving children's development and has agreed to collaborate and implement ECD activities at large scale in addition to funding it.
Hypothesis (if any): We hypothesize that it is feasible to train GoB staff at District, Upazila (Sub-district), Union and CC levels and integrate ECD activities in CCs in Bangladesh and thereby improve undernourished children's development after a year of intervention.
Objectives:
- To establish an organizational structure for the programme to be sustainable
- To establish a mechanism for sustainability at national, district and Upazila levels: including training, supervision, monitoring and reporting
- To assess the impact on maternal knowledge and depressive symptoms, stimulation in the home and child growth, cognition and language in a subsample
Methods: Undernourished children aged 6-24 months will be identified using mid-arm upper circumference (MUAC) by Govt. Health staff in 12 Upazilas of Sylhet and 11 Upazilas of Chittagong Divisions. We target to include 554 Community clinics in the programme and train approx. 1600 CC staff to deliver the parenting session. We will evaluate a subsample of the children through a 'stepped wedge design' to assess the effects of intervention using a cluster randomized controlled trial.
Outcome measures/variables: The main outcomes are coverage, compliance and fidelity of the programme. In addition, children's cognitive and language development and behaviour will be assessed in a sub-sample.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 'stepped wedge design'
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Psychosocial stimulationChildren in the intervention arm will receive sessions of psychosocial stimulation every two weeks at the community clinics for one year. The intervention includes songs, games, book and toy activities for undernourished children and nutritional and developmental messages for their mothers. |
| Wait-listed control | No intervention | –The wait-listed controls will be only tested at baseline and after a year. Following completion of the 2nd test, they will be included in the study and receive the same intervention provided to children in the experimental arm. |
Who may qualify
- Ages
- 6 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Moderately and severely malnourished children
- Aged 6-24 mo
- Both sexes
- Mid-upper arm circumference (MUAC)<12.5 cm
- Parents agree to participate in the programme.
Key exclusion criteria (3 listed)
- Children with MUAC≥12.5 cm
- Those whose parents do not consent to participate
- Children with disability, multiple births or any congenital abnormality will be included in the intervention but excluded from the evaluation sample
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 stimulationAlso: Nutritional supportChildren will receive fortnightly sessions of psychosocial stimulation and nutritional support for one year during the study period. | Behavioural | Intervention |
Primary outcome
Cognitive function
Time frame: Through study completion, an average of 1 year
Cognitive Composite scores on Bayley Scales of Infant and Toddler Development-III test, measuring children's cognition aged 1-42 months, ranging from 55 to 145. Higher values represent better outcome.
Language development
Time frame: Through study completion, an average of 1 year
Language Composite scores on Bayley Scales of Infant and Toddler Development-III test, measuring children's language aged 1-42 months, ranging from 47 to 153. Higher values represent better outcome.
8 secondary outcomes
Response to examiner
Time frame: Through study completion, an average of 1 year
Emotional Tone
Time frame: Through study completion, an average of 1 year
Cooperation with test procedure
Time frame: Through study completion, an average of 1 year
Vocalization
Time frame: Through study completion, an average of 1 year
Quality of home stimulation
Time frame: Through study completion, an average of 1 year
Anthropometry
Time frame: Through study completion, an average of 1 year
Maternal knowledge of child rearing
Time frame: Through study completion, an average of 1 year
Maternal depressive symptoms
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
- Derived from this study: PubMed 40390132Tipu SMMU, Hossain SJ, Arifeen SE, Mehrin SF, Salveen NE, Kawsir M, Bhuiyan MSA, Shiraji S, Hasan MI, Tofail F, Hamadani JD. A sustainable organizational structure to integrate psycho-social stimulation programme into primary health care services in Bangladesh: protocol for a pragmatic cluster randomized controlled trial on scaling up early childhood development activities. BMC Psychol. 2025 May 19;13(1):525. doi: 10.1186/s40359-025-02795-w.
- Individual participant dataSharing planned: No. The data will not be shared with other researchers in its present form, however, de-identified data may be shared with other researchers if they come up with any novel idea for new analysis.
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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.
Jena D Hamadani, PhD principal investigator
International Centre for Diarrhoeal Disease Research, Bangladesh
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 in people with Child 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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 13 Apr 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jena D Hamadani, PhD (+880-2-9827001 ext. 2353, jena@icddrb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive function (time frame: Through study completion, an average of 1 year). 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?
On the ClinicalTrials.gov record for NCT04093934, which also lists 1 linked publication.
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 13 Apr 2022.