Strengthening Bangladeshi Babies Brains (SBBB)
BUDHI/SBBB
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]
1 other identifier
interventional
480
1 country
1
Brief 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 clinic staff.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2022
Shorter than P25 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
August 18, 2019
CompletedFirst Posted
Study publicly available on registry
September 18, 2019
CompletedStudy Start
First participant enrolled
July 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2022
CompletedApril 13, 2022
January 1, 2022
6 months
August 18, 2019
April 12, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
Through study completion, an average of 1 year
Secondary Outcomes (8)
Response to examiner
Through study completion, an average of 1 year
Emotional Tone
Through study completion, an average of 1 year
Cooperation with test procedure
Through study completion, an average of 1 year
Vocalization
Through study completion, an average of 1 year
Quality of home stimulation
Through study completion, an average of 1 year
- +3 more secondary outcomes
Study Arms (2)
Intervention
EXPERIMENTALChildren 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 INTERVENTIONThe 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.
Interventions
Children will receive fortnightly sessions of psychosocial stimulation and nutritional support for one year during the study period.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladeshlead
- Bangor Universitycollaborator
- Institute of Child Healthcollaborator
Study Sites (1)
International Centre for Diarrhoeal Disease Research, Bangladesh
Dhaka, 1212, Bangladesh
Related Publications (1)
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.
PMID: 40390132DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jena D Hamadani, PhD
International Centre for Diarrhoeal Disease Research, Bangladesh
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 18, 2019
First Posted
September 18, 2019
Study Start
July 1, 2022
Primary Completion
December 30, 2022
Study Completion
December 30, 2022
Last Updated
April 13, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share
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.