| Field | Before | After |
|---|---|---|
| Field Abstract | Before The intervention aims to promote early childhood development and maternal-child interactions in a very poor urban environment. The importance of the first 5 years of life for long-term development is well-established. During this vital period the development of children living in poverty is hindered by malnutrition, illness and unstimulating home environments. Evidence shows that interventions in early childhood can be very important for pshychosocial development. We will implement and evaluate a cost effective intervention, delivered by local women through weekly home visits during 12 months and targeted at children 10 – 20 months and their mothers/primary caregivers. Evaluation will be by cluster randomised controlled trial. We will assess child development and conduct household and slum surveys before and after the intervention on a sample of n=400 children in 54 slums in Cuttack, Odisha, India. | After The intervention aims to promote early childhood development and maternal-child interactions in a very poor urban environment. The importance of the first 5 years of life for long-term development is well-established. During this vital period the development of children living in poverty is hindered by malnutrition, illness and unstimulating home environments. Evidence shows that interventions in early childhood can be very important for pshychosocial development. We will implement and evaluate a cost effective intervention, delivered by local women through weekly home visits during 18 months and targeted at children 10 – 20 months and their mothers/primary caregivers. Evaluation will be by cluster randomised controlled trial. We will assess child development and conduct household and slum surveys before and after the intervention on a sample of n=400 children in 54 slums in Cuttack, Odisha, India. |
| Field Trial End Date | Before January 31, 2015 | After March 31, 2016 |
| Field Last Published | Before January 23, 2014 10:56 AM | After November 25, 2015 05:42 AM |
| Field Intervention Start Date | Before November 11, 2013 | After November 20, 2013 |
| Field Intervention End Date | Before December 15, 2014 | After May 31, 2015 |
| Field Primary Outcomes (End Points) | Before Children's cognitive, language, motor, socio-emotional development, height, weight, morbidity. Quality of the home environment, play activities, play materials. Maternal depressive symptoms. Child, maternal and household socio-economic characteristics. | After Primary Outcomes Children’s cognitive, receptive language, expressive language, and fine motor development (assessed using Bayley-III at follow-up). Details of exact analysis to be performed provided in pre-analysis plan. Secondary Outcomes 1. Quality of the home stimulation environment (as measured by the 'play activities' and 'play materials' subscales of the Family Care Indicators) 2. Maternal time spent on high stimulation activities with children (as measured by time use module in household questionnaire) 3. Mother's knowledge of child development (as measured by a subset of selected items from the KIDI instrument) Details of exact analysis to be performed provided in pre-analysis plan. |
| Field Primary Outcomes (Explanation) | Before Children's cognitive, language, motor and socio-emotional development will be measured using the ASQ-3 (at baseline) and possibly an adapted version of the Bayley-III or DAS-II (at follow up). Quality of the home environment: play activities and play materials will be measured using FCI instrument at baseline and follow up. Maternal depressive symptoms will be tested using FCI questions from CES-D at baseline and follow up. Child, maternal and household socio-economic characteristics will be assessed through household survey at baseline and follow up. | After Children's cognitive, language, motor and socio-emotional development will be measured using the ASQ-3 (at baseline) and possibly an adapted version of the Bayley-III (at follow up). Quality of the home environment: play activities and play materials will be measured using FCI instrument at baseline and follow up. Mother's knowledge of child development will be assessed using the KIDI instrument. |
| Field Experimental Design (Public) | Before Intervention group: 27 clusters will receive psychosocial stimulation through weekly home visits - lasting around one hour - to mothers/primary care givers of children aged 10 - 20 months. The home visitors will be local women and will follow the Grantham-McGregor's curriculum and protocols specially adapted for the context of Odisha. They home visitors will interact with carers and children and will discuss the importance of stimulation and play for child development with the carer. Control group: 27 clusters will receive no intervention. Total duration of intervention: 12 months (2 periods of 1 month of data collection will precede and follow the interventions). | After Intervention group: 27 clusters will receive psychosocial stimulation through weekly home visits - lasting around one hour - to mothers/primary care givers of children aged 10 - 20 months. The home visitors will be local women and will follow the Grantham-McGregor's curriculum and protocols specially adapted for the context of Odisha. They home visitors will interact with carers and children and will discuss the importance of stimulation and play for child development with the carer. Control group: 27 clusters will receive no intervention. Total duration of intervention: 18 months (2 periods of 1 month of data collection will precede and follow the interventions). |
| Field Power calculation: Minimum Detectable Effect Size for Main Outcomes | Before | After We design the sample to detect a minimum effect of 33% of one standard deviation (SD) of cognitive development on a child development scale (i.e. Bayley-III) for the home visiting intervention against the control group. The level of significance is fixed at 5%, power is fixed at 80%, and the intra cluster correlation at 0.025. This is based in previous estimates from work done by members of the research team in Colombia (intra-class correlation (conditional on observables) between 0.01 and 0.04, depending on the domain of development as assessed by the Bayley-III) and in the more similar context of Bangladesh (conditional intra-class correlation on Bayley-III cognitive development has been found to be 0.01). Sample size requirements are 27 slums per treatment arm (54 total) and 7.5 children per slum on average. We are including 8 children per slum on average to allow for some sample loss between baseline and first follow up. Stratifying the sample by slum size before randomization will also increase statistical power. |
| Field Public analysis plan | Before No | After Yes |
| Field First registered on | Before | After January 23, 2014 |
| Field | Before | After |
|---|---|---|
| Field Document | Before |
After
Pre+analysis+plan+FINAL.pdf
MD5:
5731b6a3c10a0103467aba2f1b7af3bc
SHA1:
c0beb08c3b431f47ddd1bdfdd0b3cf1173462969
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| Field Title | Before | After Pre-analysis plan |