In the original COPE trial, an absolute difference of 23.6% in the prevalence of behavioural problems between the control and COPE arms (25.9% vs. 2.3%, respectively) was observed 12 months after the intervention [12]. In the proposed study, the 6-month assessment was the primary endpoint. Assuming the COPE arm to have 2.3% with behavioural problems [12] and the control arm would have the same rate as observed in Idro et al. (18.5%) [3], a sample size of 55 per group was needed for a study powered at 80%. Assuming a loss to follow-up of 10%, 60 children per arm were targeted for enrolment.

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