Abstract
BackgroundThe World Health Organization predicts that by 2030 internalising problems (e.g. depression and anxiety) will be second only to HIV/AIDS in international burden of disease. Internalising problems affect 1 in 7 school aged children, impacting on peer relations, school engagement, and later mental health, relationships and employment. The development of early childhood prevention for internalising problems is in its infancy. The current study follows two successful 'efficacy' trials of a parenting group intervention to reduce internalising disorders in temperamentally inhibited preschool children. Cool Little Kids is a population-level randomised trial to determine the impacts of systematically screening preschoolers for inhibition then offering a parenting group intervention, on child internalising problems and economic costs at school entry.Methods/DesignThis 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 ≈16% (n≈500) 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.DiscussionThis 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.Trial RegistrationISRCTN: ISRCTN30996662RCH Human Research Ethics Approval30105A
Highlights
The World Health Organization predicts that by 2030 internalising problems will be second only to HIV/AIDS in international burden of disease
This trial addresses gaps for internalising problems identified in the 2004 World Health Organization Prevention of Mental Disorders report
Governments consider mental health to be a priority, enhancing the likelihood that an effective early prevention program would be adopted in Australia and internationally
Summary
This translational randomised trial aims to determine ‘effectiveness’ of the Cool Little Kids program administered across the population. Rapee’s recent efficacy studies will be extended to: a) determine the balance of benefits and harms of systematically screening preschoolers for temperamental inhibition b) determine the balance of benefits and harms of a parenting intervention program offered from a universal preschool platform to all at risk children in the year prior to school, c) examine the impacts on internalising problems at school entry, a key developmental point of considerable policy interest internationally, d) include time-efficient and valid screening and outcome assessments including parenting practices and parent mental health (in addition to child internalising problems), and e) evaluate cost-effectiveness, to inform policy and service delivery An outcome of this translational trial could be systematic screening leading to routine prevention for all or most preschoolers at risk, building on existing universal preschool and healthcare systems. In Australia and internationally, governments currently consider mental health and early prevention to be a priority
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