Impacts 2 years after a scalable early childhood development intervention to increase psychosocial stimulation in the home: A follow-up of a cluster randomised controlled trial in Colombia.

BACKGROUND: Poor early childhood development (ECD) in low- and middle-income countries is a major concern. There are calls to universalise access to ECD interventions through integrating them into existing government services but little evidence on the medium- or long-term effects of such scalable models. We previously showed that a psychosocial stimulation (PS) intervention integrated into a cash transfer programme improved Colombian children's cognition, receptive language, and home stimulation. In this follow-up study, we assessed the medium-term impacts of the intervention, 2 years after it ended, on children's cognition, language, school readiness, executive function, and behaviour. METHODS AND FINDINGS: Study participants were 1,419 children aged 12-24 months at baseline from beneficiary households of the cash transfer programme, living in 96 Colombian towns. The original cluster randomised controlled trial (2009-2011) randomly allocated the towns to control (N = 24, n = 349), PS (N = 24, n = 357), multiple micronutrient (MN) supplementation (N = 24, n = 354), and combined PS and MN (N = 24, n = 359). Interventions lasted 18 months. In this study (26 September 2013 to 11 January 2014), we assessed impacts on cognition, language, school readiness, executive function, and behaviour 2 years after intervention, at ages 4.5-5.5 years. Testers, but not participants, were blinded to treatment allocation. Analysis was on an intent-to-treat basis. We reassessed 88.5% of the children in the original study (n = 1,256). Factor analysis of test scores yielded 2 factors: cognitive (cognition, language, school readiness, executive function) and behavioural. We found no effect of the interventions after 2 years on the cognitive factor (PS: -0.031 SD, 95% CI -0.229-0.167; MN: -0.042 SD, 95% CI -0.249-0.164; PS and MN: -0.111 SD, 95% CI -0.311-0.089), the behavioural factor (PS: 0.013 SD, 95% CI -0.172-0.198; MN: 0.071 SD, 95% CI -0.115-0.258; PS and MN: 0.062 SD, 95% CI -0.115-0.239), or home stimulation. Study limitations include that behavioural development was measured through maternal report and that very small effects may have been missed, despite the large sample size. CONCLUSIONS: We found no evidence that a scalable PS intervention benefited children's development 2 years after it ended. It is possible that the initial effects on child development were too small to be sustained or that the lack of continued impact on home stimulation contributed to fade out. Both are likely related to compromises in implementation when going to scale and suggest one should not extrapolate from medium-term effects of small efficacy trials to scalable interventions. Understanding the salient differences between small efficacy trials and scaled-up versions will be key to making ECD interventions effective tools for policymakers. TRIAL REGISTRATION: ISRCTN18991160.

Why is multiple micronutrient powder ineffective at reducing anaemia among 12-24 month olds in Colombia? Evidence from a randomised controlled trial.

In Colombia's bottom socio-economic strata, 46.6% of children under two are anaemic. A prevalence of above 20% falls within the WHO guidelines for daily supplementation with multiple micronutrient powder (MNP). To evaluate the effect of daily MNP supplementation on anaemia amongst Colombian children aged 12-24 months we ran a cluster RCT (n=1440). In previous work, we found the intervention had no impact on haemoglobin or anaemia in this population. In this current paper, we investigate this null result and find it cannot be explained by an underpowered study design, inaccurate measurements, low adoption of and compliance with the intervention, or crowding out through dietary substitution. We conclude that our intervention was ineffective at reducing rates of childhood anaemia because MNP itself was inefficacious in our population, rather than poor implementation of or adherence to the planned intervention. Further analysis of our data and secondary data suggests that the evolution with age of childhood anaemia in Colombia, and its causes, appear different from those in settings where MNP has been effective. Firstly, rates of anaemia peak at much earlier ages and then fall rapidly. Secondly, anaemia that remains after the first year of life is relatively, and increasingly as children get older, unrelated to iron deficiency. We suggest that factors during gestation, birth, breastfeeding and early weaning may be important in explaining very high rates of anaemia in early infancy. However, the adverse effects of these factors appear to be largely mitigated by the introduction of solid foods that often include meat. This renders population wide MNP supplementation, provided after a diet of solid foods has become established, an ineffective instrument with which to target Colombia's childhood anaemia problem.

Using the infrastructure of a conditional cash transfer program to deliver a scalable integrated early child development program in Colombia: cluster randomized controlled trial.

OBJECTIVE: To assess the effectiveness of an integrated early child development intervention, combining stimulation and micronutrient supplementation and delivered on a large scale in Colombia, for children's development, growth, and hemoglobin levels. DESIGN: Cluster randomized controlled trial, using a 2 × 2 factorial design, with municipalities assigned to one of four groups: psychosocial stimulation, micronutrient supplementation, combined intervention, or control. SETTING: 96 municipalities in Colombia, located across eight of its 32 departments. PARTICIPANTS: 1420 children aged 12-24 months and their primary carers. INTERVENTION: Psychosocial stimulation (weekly home visits with play demonstrations), micronutrient sprinkles given daily, and both combined. All delivered by female community leaders for 18 months. MAIN OUTCOME MEASURES: Cognitive, receptive and expressive language, and fine and gross motor scores on the Bayley scales of infant development-III; height, weight, and hemoglobin levels measured at the baseline and end of intervention. RESULTS: Stimulation improved cognitive scores (adjusted for age, sex, testers, and baseline levels of outcomes) by 0.26 of a standard deviation (P=0.002). Stimulation also increased receptive language by 0.22 of a standard deviation (P=0.032). Micronutrient supplementation had no significant effect on any outcome and there was no interaction between the interventions. No intervention affected height, weight, or hemoglobin levels. CONCLUSIONS: Using the infrastructure of a national welfare program we implemented the integrated early child development intervention on a large scale and showed its potential for improving children's cognitive development. We found no effect of supplementation on developmental or health outcomes. Moreover, supplementation did not interact with stimulation. The implementation model for delivering stimulation suggests that it may serve as a promising blueprint for future policy on early childhood development.Trial registration Current Controlled trials ISRCTN18991160.