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.

Note: The content above has been extracted from a research article, so it may not display correctly.

Please log in to submit your questions online.
Your question will be posted on the Bio-101 website. We will send your questions to the authors of this protocol and Bio-protocol community members who are experienced with this method. you will be informed using the email address associated with your Bio-protocol account.

We use cookies on this site to enhance your user experience. By using our website, you are agreeing to allow the storage of cookies on your computer.