Early Childhood Development in the Slums of Cuttack, Odisha, India.

We will carry out a stimulation programme that aims to improve the interaction between mothers and their infants in everyday activities by introducing a systematic week-by-week curriculum that follows the natural developmental stage of the child. The curriculum will be delivered by local women (home visitor) during weekly individual home visits to 400 children, aged 10 - 20 months at the start of the intervention, and their caregivers.
The key organising element of the home visit will be the curriculum and protocols originally developed by Sally Grantham-McGregor specialy adapted for the context of Odisha. The curriculum is progressive and enables the facilitator to let the child dictate the pace. Emphasis is placed on improving maternal-child interaction, using positive reinforcement, and on using everyday child care activities and household tasks to teach the child new words and concepts. During the visits, the facilitator will interact with the mother and her young child and will demonstrate play activities using home-made toys and objects around the home. She will also discuss child development with the mother and emphasise the importance of chatting and play. As part of this research project, we will ensure that the curriculum is both age relevant and adapted to the cultural context.

2013-11-20

2015-05-31

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.

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.

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).

The randomisation is conducted by a computer in the office, using the statistical program Stata version 12. The steps we follow are:
1. Identify sample of eligible slums: this means those with at least 7 children in the defined age range (10 - 20 months). Exclude children with physical or mental disabilities and twins.
2. Stratify sample of slums by slum size, i.e. the stratification variable is an indicator = 1 if the slum has more than nine children in our target age range according to the initial listing conducted in the slums, 0 otherwise.
3. Within strata,
3.1 randomly assign a number between 0 and 1 to each slum;
3.2 sort the number of slums by randomly assigned number;
3.3 assign the first half of the slums to treatment and the second half to control.

Slums with at least 7 children aged 10 - 20 months.

Yes

54 slums.

400 children in the target age range.

27 slum intervention group, 27 slum control group.

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.

Pre-analysis plan