Children Learning About Second-hand Smoke (CLASS II): A pilot cluster randomised controlled trial (360G-Wellcome-107440_Z_15_Z)

The principal question for our planned follow-on definitive trial is: What isthe effectiveness and cost-effectiveness of a school-based intervention,‘Smoke Free Homes’ (SFH) in reducing children’s exposure to second-hand smoke (primary outcome),frequency and severity of respiratory illnesses, healthcare contacts, school absenteeism, smoking uptake andin improving their lung function, quality of life and school performance?Prior to conducting a definitive trial to answer the above question, we wish to first conduct a pilot trial thatinforms the parameters required for conducting the definitive trial. Our specific research questions for thispilot study are therefore to ascertain:1. What are the recruitment and attrition rates for schools (clusters) and children?2. What is the feasibility and acceptability of measuring the primary and secondary outcomes?3. What is the likely effect size and its variance in relation to the primary outcome measure?4. What is the Intracluster Correlation Coefficient (ICC) among children for the trial outcomes?5. What is the fidelity of delivering ‘Smoke Free Homes’ in schools?6. What are the costs associated with delivering ‘Smoke Free Homes’ through schools?7. What would facilitate and hinder in scaling up ‘Smoke Free Homes’ in schools and their curriculum?8. What is the frequency and nature of any adverse events?