Clinical trial NCT04093934: Strengthening Bangladeshi Babies Brains (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]
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Child Development
Keywords: Early childhood development
Psychosociaal stimulation
Bayley test
Bangladesh
Undernutrition
Stepped wedge design
Cluster randomized controlled trial
Lead sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh
Sponsor class: OTHER
Collaborators: name: Bangor University
name: Institute of Child Health
First posted: 2019-09-18
Enrollment: 480
Sex: ALL
Minimum age (years): 6
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 'stepped wedge design'
Primary purpose: TREATMENT

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):

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.

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

Primary outcomes:
measure: Cognitive function
timeFrame: Through study completion, an average of 1 year
measure: Language development
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Response to examiner
timeFrame: Through study completion, an average of 1 year
measure: Emotional Tone
timeFrame: Through study completion, an average of 1 year
measure: Cooperation with test procedure
timeFrame: Through study completion, an average of 1 year
measure: Vocalization
timeFrame: Through study completion, an average of 1 year
measure: Quality of home stimulation
timeFrame: Through study completion, an average of 1 year
measure: Anthropometry
timeFrame: Through study completion, an average of 1 year
measure: Maternal knowledge of child rearing
timeFrame: Through study completion, an average of 1 year
measure: Maternal depressive symptoms
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: International Centre for Diarrhoeal Disease Research, Bangladesh
Study officials:
affiliation: International Centre for Diarrhoeal Disease Research, Bangladesh
name: Jena D Hamadani, PhD
role: PRINCIPAL_INVESTIGATOR
References: