Strengthening Bangladeshi Babies Brains (SBBB)

Child Development Clinical Trial

— BUDHI/SBBB  

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]

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04093934
• Other study ID #: PR-19040
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2022
• Est. completion date: December 30, 2022

Study information

• Verified date: January 2022
• Source: International Centre for Diarrhoeal Disease Research, Bangladesh
• Contact: Jena D Hamadani, PhD
• Phone: +880-2-9827001
• Email: jena[@]icddrb.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 clinic staff.

Description:

Background (brief): 1. 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. 2. 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. 3. 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: 1. To establish an organizational structure for the programme to be sustainable 2. To establish a mechanism for sustainability at national, district and Upazila levels: including training, supervision, monitoring and reporting 3. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 480
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 24 Months

Eligibility

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

Related Conditions & MeSH terms

• Child Development

Intervention

Behavioral:
• Psychosocial stimulation
Children will receive fortnightly sessions of psychosocial stimulation and nutritional support for one year during the study period.

Locations

Country	Name	City	State
Bangladesh	International Centre for Diarrhoeal Disease Research, Bangladesh	Dhaka

Sponsors (3)

Lead Sponsor	Collaborator
International Centre for Diarrhoeal Disease Research, Bangladesh	Bangor University, Institute of Child Health

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Emotional Tone	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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