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Background (brief):
Hypothesis (if any): The Investigators hypothesize that the identified strategies would be effective in improving children's development.
Objectives:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm 1: Stimulation intervnetion | Active Comparator |
| |
| Intervention Arm 2: New stimulation intervention | Experimental |
| |
| Unique control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psychosocial stimulation | Behavioral | Intervention Arm 1: Pschosocial stimulation intervention using toys made by the programme. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive development | 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. | From enrollment to the end of intervention after 6 months |
| Language | 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. | From enriollment to after 6 months intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Children's Behavior | Children's behavior will be assessed using the Wolke's Behavior Rating Scale during the cognitive and language assessment period. | From enrollment to the end of intervention after 6 months |
| Children's weight |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icddr,B | Dhaka | Bangladesh |
Participants ID, Age, Sex, Socio-economic and demographic information, Treatment group code
Beginning 6 months and ending 3 years after the publication of results
Data will be shared upon request as per icddrb data repository criteria
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| Combined | Behavioral | Intervention Arm 2: Psychosocial stimulation intervnetion using toys made by mothers. |
|
Weight measurement in Kg
| From enrollment to the end of intervention after 6 months |
| Children's length | Length in Cm | From enrollment to the end of intervention after 6 months |
| Home stimulation | Children's home stimulation will be assessed using Family Care Indicator (FCI) | From enrollment to the end of intervention after 6 months |
| Maternal knowledge on child caring practices | Maternal knowledge on child caring practices will be assessed using a structured questionnaire. | From enrollment to the end of intervention after 6 months. |
| Maternal depression | Maternal depressive symptoms will be assessed using the shortened version Centre for Epidemiological Studies-Depression scale | From enrollment to the end of intervention after 6 months |