Strengthening Bangladeshi Babies Brains (SBBB) (BUDHI/SBBB)

International Centre for Diarrhoeal Disease Research (icddr,b)

Status: Unknown

Conditions: Child Development

Treatments: Behavioral: Psychosocial stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04093934

PR-19040

Details and patient eligibility

About

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.

Full 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.

Enrollment: 480 estimated patients

Sex: All

Ages: 6 to 24 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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480 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Psychosocial stimulation

Wait-listed control

No Intervention group

Description:

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.