Icddr,B
Dhaka, Bangladesh
NCT Number: NCT07472699
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.
This study is active but is not currently recruiting participants.
Notify Me6 month–24 month
All sexes
Interventional
Not applicable
Dhaka, Bangladesh
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intervention Arm 1: Pschosocial stimulation intervention using toys made by the programme.
Intervention Arm 2: Psychosocial stimulation intervnetion using toys made by mothers.
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.
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.
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.
Time frame: From enrollment to the end of intervention after 6 months
Weight measurement in Kg
Time frame: From enrollment to the end of intervention after 6 months
Length in Cm
Time frame: From enrollment to the end of intervention after 6 months
Children's home stimulation will be assessed using Family Care Indicator (FCI)
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.
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
International Centre for Diarrhoeal Disease Research, Bangladesh
Other
Extending and Enhancing the Ongoing Early Childhood Development (ECD) Scale-up Programme (Saving Bangladeshi Babies Brain (SB3) in Bangladesh
Acronym: ECD SB3
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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.