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NCT Number: NCT07472699

Enhancing the Ongoing ECD Scale-up Programme (Saving Bangladeshi Babies Brain (SB3) in Bangladesh

Background (brief):

1. Burden: Globally 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. 2. Knowledge gap: The early childhood intervention curriculum 'Reach up & Learn' has been adapted for Bangladesh and were successfully used in 10 trials including two trials integrated with Primary Health Care (PHC) services implemented in Community Clinics. Based on the success of the last two studies, the current programme 'Saving Bangladeshi Babies Brains (SB3)' is conducted in 4 districts. Under this programme, a small cluster randomised controlled trial (cRCT) was conducted and found no benefit on child development. However, the programme involved implementation challanges. Therefore, there is a need to determine the strategies to mitigate the challenges and conduct another round of cRCT to test the effectiveness of the strategies on the child development outcomes. 3. Relevance: Bangladesh Govt acknowledges the need for improving children's development and has agreed to collaborate and implement early childhood development (ECD) activities at large scale.

Hypothesis (if any): The Investigators hypothesize that the identified strategies would be effective in improving children's development.

Objectives:

1. To identify the potential strategies to promote the quality and fidelity of the SB3 early childhood parenting programme integrated into government health care services. 2. To measure the effectivity of the intervnetion on the cogntion, langauge, motor development, and beahvior of the children and maternal parenting knowledge and quality of stimulation at home.

Methods: A mixed-method data collection has been conducted and three potential strategies were identified: raising community awareness, increasing health worker's motivation to deliver a quality programme, and the revised curriculum by replacing mothers' made toys to the supplied toys from the progarmme. These startegies will be piloted. And based on the pilot findings, two strategies will be selected to test the effectiveness on child development using a cluster randomised controlled trial design. In the cluster RCT, there will be two arms : i) intervnetion arm I: regular curriclum, ii) intervnetion arm II: revised curriculum and iii) Unique control. Twenty unions from each programme running district will be randomly selected and then randomly allocated to intervention arm I & II . A four non-programme running districts located at the border of the programme districts will be selected as unique control. The children will be tested at the beginning and the end of the 6 months of intervention.

Outcome measures/variables: The primary outcomes are children's cognition, and language development and the secondary outcomes are children's behaviour and growth, maternal knowledge on child care and their practices, home stimulation and maternal depressive symptoms.

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Key information

Age range

6 month–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Icddr,B

Dhaka, Bangladesh

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Moderately and severely malnourished children aged 6-24 months of both sexes and whose parents agree to participate in the programme.
  • Mid-upper arm circumference (MUAC)<13.5cm will be used to define malnutrition
  • Maternal education qualification less than 8th grade
  • Monthly family income BDT<15000

Exclusion criteria

  • Children with MUAC≥13.5 cm
  • Those whose parents do not consent to participate

Treatment and study plan

Psychosocial stimulation

Behavioral

Intervention Arm 1: Pschosocial stimulation intervention using toys made by the programme.

Combined

Behavioral

Intervention Arm 2: Psychosocial stimulation intervnetion using toys made by mothers.

Primary outcomes

  1. Cognitive development

    Time frame: From enrollment to the end of intervention after 6 months

    The primary outcomes are children's cognition, which will be assessed using the psychometric tool named "Bayley Scale of Infant and Toddler Development Version-IV'. The cognition scales include a series of developmental play tasks based on different abilities like memory, problem solving skill, number concepts, etc.

  2. Language

    Time frame: From enriollment to after 6 months intervention.

    Children's language will be assessed using the psychometric tool named "Bayley Scale of Infant and Toddler Development Version-IV'. Language subscale contains two components: receptive and expressive test.

Secondary outcomes

  1. Children's Behavior

    Time frame: From enrollment to the end of intervention after 6 months

    Children's behavior will be assessed using the Wolke's Behavior Rating Scale during the cognitive and language assessment period.

  2. Children's weight

    Time frame: From enrollment to the end of intervention after 6 months

    Weight measurement in Kg

  3. Children's length

    Time frame: From enrollment to the end of intervention after 6 months

    Length in Cm

  4. Home stimulation

    Time frame: From enrollment to the end of intervention after 6 months

    Children's home stimulation will be assessed using Family Care Indicator (FCI)

  5. Maternal knowledge on child caring practices

    Time frame: From enrollment to the end of intervention after 6 months.

    Maternal knowledge on child caring practices will be assessed using a structured questionnaire.

  6. Maternal depression

    Time frame: From enrollment to the end of intervention after 6 months

    Maternal depressive symptoms will be assessed using the shortened version Centre for Epidemiological Studies-Depression scale

Sponsors and collaborators

Lead sponsor

International Centre for Diarrhoeal Disease Research, Bangladesh

Other

Registry information

Official study title

Extending and Enhancing the Ongoing Early Childhood Development (ECD) Scale-up Programme (Saving Bangladeshi Babies Brain (SB3) in Bangladesh

Acronym: ECD SB3

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 16, 2026
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.