%0 Journal Article %T The Cool Little Kids randomised controlled trial: Population-level early prevention for anxiety disorders %A Jordana K Bayer %A Ronald M Rapee %A Harriet Hiscock %A Obioha C Ukoumunne %A Cathrine Mihalopoulos %A Susan Clifford %A Melissa Wake %J BMC Public Health %D 2011 %I BioMed Central %R 10.1186/1471-2458-11-11 %X This randomised trial will be conducted within the preschool service system, attended by more than 95% of Australian children in the year before starting school. In early 2011, preschool services in four local government areas in Melbourne, Australia, will distribute the screening tool. The ¡Ö16% (n¡Ö500) with temperamental inhibition will enter the trial. Intervention parents will be offered Cool Little Kids, a 6-session group program in the local community, focusing on ways to develop their child's bravery skills by reducing overprotective parenting interactions. Outcomes one and two years post-baseline will comprise child internalising diagnoses and symptoms, parenting interactions, and parent wellbeing. An economic evaluation (cost-consequences framework) will compare incremental differences in costs of the intervention versus control children to incremental differences in outcomes, from a societal perspective. Analyses will use the intention-to-treat principle, using logistic and linear regression models (binary and continuous outcomes respectively) to compare outcomes between the trial arms.This trial addresses gaps for internalising problems identified in the 2004 World Health Organization Prevention of Mental Disorders report. If effective and cost-effective, the intervention could readily be applied at a population level. Governments consider mental health to be a priority, enhancing the likelihood that an effective early prevention program would be adopted in Australia and internationally.ISRCTN: ISRCTN3099666230105AFew people in modern societies are untouched by internalising problems, a broad term that refers to emotional distress and encompasses the spectrum of emotional symptoms of anxiety and depression. Although in clinical practice anxiety and depression disorders are seen as multiple, distinct diagnoses, empirical evidence shows high overlap between them and supports use of the broad term internalising problems [1,2]. The World Health Organization (W %U http://www.biomedcentral.com/1471-2458/11/11