Strengthening Bangladeshi Babies Brains (SBBB)

Study Overview
=================
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.

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.

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]

Conditions
-----------------
Child Development

Intervention / Treatment
-----------------
* Behavioral: Psychosocial stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 24 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 'stepped wedge design'
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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. | Behavioral: Psychosocial stimulation<br>* Children will receive fortnightly sessions of psychosocial stimulation and nutritional support for one year during the study period.<br>* Other names: Nutritional support;|
| No Intervention: Wait-listed control<br>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 the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Early childhood development, Psychosociaal stimulation, Bayley test, Bangladesh, Undernutrition, Stepped wedge design, Cluster randomized controlled trial