- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04093934
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]
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jena D Hamadani, PhD
- Phone Number: 2353 +880-2-9827001
- Email: jena@icddrb.org
Study Contact Backup
- Name: Fahmida Tofail, PhD
- Phone Number: +8801715700370
- Email: ftofail@icddrb.org
Study Locations
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-
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Dhaka, Bangladesh, 1212
- International Centre for Diarrhoeal Disease Research, Bangladesh
-
Contact:
- Jena D Hamadani, PhD
- Phone Number: 2350 +880-2-9827001
- Email: jena@icddrb.org
-
Contact:
- Fahmida Tofail, PhD
- Phone Number: +880-2-9827001
- Email: ftofail@icddrb.org
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Principal Investigator:
- Jena D Hamadani, PhD
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Sub-Investigator:
- Fahmida Tofail, PhD
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Sub-Investigator:
- Shams E Arifeen, PhD
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Sub-Investigator:
- Syeda F Mehrin, MSC
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Sub-Investigator:
- Sheikh J Hossain, MPH
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Sub-Investigator:
- Mohammed I Hasan, MPH
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Sub-Investigator:
- Afroza Hilaly, MSC
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Sub-Investigator:
- Dewan E Hoque, PhD
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Sub-Investigator:
- Shamima Shiraji, MSC
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Sub-Investigator:
- Ahmed I Anwar, PhD
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Sub-Investigator:
- Sally Grantham-McGregor, FRCP
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Sub-Investigator:
- Helen Baker-Henningham, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Intervention
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.
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Children will receive fortnightly sessions of psychosocial stimulation and nutritional support for one year during the study period.
Other Names:
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NO_INTERVENTION: Wait-listed control
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Through study completion, an average of 1 year
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Language development
Time Frame: Through study completion, an average of 1 year
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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.
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Through study completion, an average of 1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response to examiner
Time Frame: Through study completion, an average of 1 year
|
Wolke's Behaviour ratings measuring response to examiner of children aged 1-42 months ranging from 1-9.
Higher values represent better outcome.
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Through study completion, an average of 1 year
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Emotional Tone
Time Frame: Through study completion, an average of 1 year
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Wolke's Behaviour ratings measuring emotional tone of children aged 1-42 months ranging from 1-9.
Higher values represent better outcome.
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Through study completion, an average of 1 year
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Cooperation with test procedure
Time Frame: Through study completion, an average of 1 year
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Wolke's Behaviour ratings measuring cooperativeness of children aged 1-42 months ranging from 1-9.
Higher values represent better outcome.
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Through study completion, an average of 1 year
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Vocalization
Time Frame: Through study completion, an average of 1 year
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Wolke's Behaviour ratings measuring vocalization of children aged 1-42 months ranging from 1-9.
Higher values represent better outcome.
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Through study completion, an average of 1 year
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Quality of home stimulation
Time Frame: Through study completion, an average of 1 year
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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.
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Through study completion, an average of 1 year
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Anthropometry
Time Frame: Through study completion, an average of 1 year
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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.
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Through study completion, an average of 1 year
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Maternal knowledge of child rearing
Time Frame: Through study completion, an average of 1 year
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Pre-designed and previously used questionnaire measuring maternal knowledge of child development, ranging from 0-50.
Higher values represent better outcome.
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Through study completion, an average of 1 year
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Maternal depressive symptoms
Time Frame: Through study completion, an average of 1 year
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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.
|
Through study completion, an average of 1 year
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Collaborators and Investigators
Investigators
- Principal Investigator: Jena D Hamadani, PhD, International Centre for Diarrhoeal Disease Research, Bangladesh
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PR-19040
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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