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| Name | Class |
|---|---|
| Bangor University | OTHER |
| Institute of Child Health | OTHER |
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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.
Background (brief):
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psychosocial stimulation | Behavioral | Children will receive fortnightly sessions of psychosocial stimulation and nutritional support for one year during the study period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through study completion, an average of 1 year |
| Emotional Tone |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jena D Hamadani, PhD | Contact | +880-2-9827001 | 2353 | jena@icddrb.org |
| Fahmida Tofail, PhD | Contact | +8801715700370 | ftofail@icddrb.org |
| Name | Affiliation | Role |
|---|---|---|
| Jena D Hamadani, PhD | International Centre for Diarrhoeal Disease Research, Bangladesh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| International Centre for Diarrhoeal Disease Research, Bangladesh | Dhaka | 1212 | Bangladesh |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40390132 | Derived | 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. |
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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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| ID | Term |
|---|---|
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D018529 | Nutritional Support |
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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'stepped wedge design'
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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.
| 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. | 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. | 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. | 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. | 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. | 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. | Through study completion, an average of 1 year |