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Background: The 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/Design: 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 ≉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 (costconsequences 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. Discussion: 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. Trial Registration: ISRCTN30996662 RCH Human Research Ethics Approval: 30105A [ABSTRACT FROM AUTHOR]

Background: Anxiety disorders are the most common type of mental health problem and begin early in life. Early intervention to prevent anxiety problems in young children who are at risk has the potential for long-term impact. The 'Cool Little Kids' parenting group program was previously established to prevent anxiety disorders in young children at risk because of inhibited temperament. This group program was efficacious in two randomised controlled trials and has recently been adapted into an online format. 'Cool Little Kids Online' was developed to widen and facilitate access to the group program's preventive content. A pilot evaluation of the online program demonstrated its perceived utility and acceptability among parents. This study aims to evaluate the efficacy of Cool Little Kids Online in a large randomised controlled trial.Methods/design: Parents of young children who are 3-6 years old and who have an inhibited temperament will be recruited (n = 385) and randomly assigned to either immediate access to Cool Little Kids Online or delayed access after a waiting period of 24 weeks. The online program contains eight modules that help parents address key issues in the development of anxiety problems in inhibited children, including children's avoidant coping styles, overprotective parenting behaviours, and parents' own fears and worries. Intervention participants will be offered clinician support when requested. The primary outcome will be change in parent-reported child anxiety symptoms. Secondary outcomes will be child internalising symptoms, child and family life interference due to anxiety, over-involved/protective parenting, plus child anxiety diagnoses assessed by using a new online diagnostic tool. Assessments will take place at baseline and 12 and 24 weeks after baseline.Discussion: This trial expands upon previous research on the Cool Little Kids parenting group program and will evaluate the efficacy of online delivery. Online delivery of the program could result in an easily accessible evidence-based resource to help families with young children at temperamental risk for anxiety disorders.Trial Registration: Australian New Zealand Clinical Trials Registry 12615000217505 (registered 5 March 2015). [ABSTRACT FROM AUTHOR]

Background : The Minimising Young Children's Anxiety through Schools (MY-CATS) trial is being conducted to determine whether an online evidence-based parent-guided cognitive behavioural therapy intervention in addition to usual school practice is effective and cost-effective compared with usual school practice in reducing anxiety disorders in children aged 4–7 deemed 'at risk' of anxiety disorders. This update article describes the detailed statistical analysis plan for the MY-CATS trial and reports a review of the underpinning sample size assumptions. Methods and design: The MY-CATS study is a two-arm, definitive superiority pragmatic parallel group cluster randomised controlled trial in which schools will be randomised 1:1 to receive either the intervention (in addition to usual school practice) or the usual school practice only. This update to the (published) protocol provides a detailed description of the study methods, the statistical principles, the trial population and the planned statistical analyses, including additional analyses comprising instrumental variable regression and mediation analysis. Trial registration: ISRCTN82398107. Prospectively registered on 14 January 2021 [ABSTRACT FROM AUTHOR]

Background: The 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/design: 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 ≈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.Discussion: 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. RCH HUMAN RESEARCH ETHICS APPROVAL: 30105A. [ABSTRACT FROM AUTHOR]

Background: Identifying and supporting young children who are at risk of developing anxiety disorders would benefit children, families, and wider society. Elevated anxiety symptoms, inhibited temperament, and high parental anxiety are established risk factors for later anxiety disorders, but it remains unclear who is most likely to benefit from prevention and early intervention programmes. Delivering an online intervention through schools to parents of young children who have one or more of these risks could maximise reach. The primary aim of this trial is to evaluate the effectiveness and cost-effectiveness of delivering an online parent-led intervention, compared with usual school provision only, for children (aged 4-7) identified as at risk for anxiety disorders on the basis of at least one risk factor. We also aim to identify the characteristics of children who do and do not benefit from intervention and mechanisms of change from the intervention.Methods: The design will be a parallel group, superiority cluster randomised controlled trial, with schools (clusters) randomised to intervention or usual school practice arms in a 1:1 ratio stratified according to level of deprivation within the school. The study will recruit and randomise at least 60 primary/infant schools in England, and on the basis of recruiting 60 schools, we will recruit 1080 trial participants (540 per arm). Parents of all children (aged 4-7) in sampled Reception, Year 1, and Year 2 classes will be invited to complete screening questionnaires. Children who screen positive on the basis of anxiety symptoms, and/or behavioural inhibition, and/or parent anxiety symptoms will be eligible for the trial. Parents/carers of children in schools allocated to the intervention arm will be offered a brief online intervention; schools in both arms will continue to provide any usual support for children and parents throughout the trial. Assessments will be completed at screening, baseline (before randomisation), 6 weeks, 12 weeks, and 12 months post-randomisation. The primary outcome will be the absence/presence of an anxiety disorder diagnosis at 12 months.Discussion: The trial will determine if delivering an online intervention for parents of young children at risk of anxiety disorders identified through screening in schools is effective and cost-effective.Trial Registration: ISRCTN 82398107 . Prospectively registered on Jan. 14, 2021. [ABSTRACT FROM AUTHOR]

Background: Autism spectrum disorder (ASD) is found in approximately 1% of the population and includes core symptoms that affect general and social development. Beside these core symptoms, it is suggested that up to 60% of children with ASD suffer from comorbid anxiety disorders which may further affect educational, social and general development as well as quality of life. The main goal of this study is to examine the effectiveness of a manualized cognitive behavioral therapy (CBT) anxiety program adapted for children with ASD.Methods: This study is a randomized controlled trial (RCT). Fifty children with ASD and anxiety, aged 7 to 13 years, will be randomly assigned to group CBT or a wait-list control (WL) condition. The design will follow a two (CBT and WL) by two (pre-post assessment) mixed between-within design. The control group will receive intervention after the waitlist period of 13 weeks. Primary outcomes are diagnostic status and severity of the anxiety disorders, measured with The Anxiety Disorder Interview Schedule for DSM-IV, Parent and Child Versions. Secondary outcomes are parent and child ratings on questionnaires on the child's level of anxiety and impact on everyday life. Additional outcomes entail information gathered from parents, child and teachers on the child's behavior and negative self-statements, together with social and adaptive skills. Follow-up data will be collected 3 months after intervention.Discussion: This study aims to evaluate the effectiveness of a manualized CBT program in Danish children with ASD and anxiety within a mental health clinic setting. The hypothesis is that training anxiety reduction skills will decrease anxiety in children, as well as ensure better psychosocial development for the child in general.Trial Registration: https://ClinicalTrials.gov ( NCT02908321 ). Registered 19th of September 2016. [ABSTRACT FROM AUTHOR]

Background: Alcohol use disorders and social anxiety disorder are common and disabling conditions that frequently co-exist. Although there are efficacious treatments for each disorder, only two randomized controlled trials of interventions for these combined problems have been published. We developed a new integrated treatment for comorbid Social Anxiety Disorder and Alcohol Use Disorder based on established Motivational Interviewing (MI) and Cognitive Behaviour Therapy (CBT) interventions for the separate disorders. Compared to established MI/CBT for alcohol use disorders this new intervention is hypothesised to lead to greater reductions in symptoms of social anxiety and alcohol use disorder and to produce greater improvements in quality of life. Higher levels of alcohol dependence will result in relatively poorer outcomes for the new integrated treatment. Methods/design: A randomised controlled trial comparing 9 sessions of individual integrated treatment for alcohol and social phobia with 9 sessions of treatment for alcohol use problems alone is proposed. Randomisation will be stratified for stable antidepressant use. Post treatment clinical assessments of alcohol consumption and diagnostic status at 3 and 6 month follow-up will be blind to allocation. Discussion: The proposed trial addresses a serious gap in treatment evidence and could potentially define the appropriate treatment for a large proportion of adults affected by these problems. [ABSTRACT FROM AUTHOR]

Background: Up to 60% of children with Attention-Deficit/Hyperactivity Disorder (ADHD) meet diagnostic criteria for at least one anxiety disorder, including Social, Generalized and/or Separation Disorder. Anxiety in children with ADHD has been shown to be associated with poorer child and family functioning. Small pilot studies suggest that treating anxiety in children with ADHD using cognitive-behavioral therapy (CBT) has promising benefits. In a fully powered randomized controlled trial (RCT), we aim to investigate the efficacy of an existing CBT intervention adapted for children with ADHD and comorbid anxiety compared with usual care. Methods: This RCT is recruiting children aged 8–12 years (N = 228) from pediatrician practices in Victoria, Australia. Eligibility criteria include meeting full diagnostic criteria for ADHD and at least one anxiety disorder (Generalized, Separation or Social). Eligible children are randomized to receive a 10 session CBT intervention (Cool Kids) versus usual clinical care from their pediatrician. The intervention focuses on building child and parent skills and strategies to manage anxiety and associated impairments including cognitive restructuring and graded exposure. Minor adaptations have been made to the delivery of the intervention to meet the needs of children with ADHD including increased use of visual materials and breaks between activities. The primary outcome is change in the proportion of children meeting diagnostic criteria for an anxiety disorder at 5 months randomization. This will be assessed via diagnostic interview with the child's parent (Anxiety Disorders Interview Schedule for Children V) conducted by a researcher blinded to intervention condition. Secondary outcomes include a range of child (e.g., anxiety symptoms, ADHD severity, behavior, quality of life, sleep, cognitive functioning, school attendance) and parent (e.g., mental health, parenting behaviors, work attendance) domains of functioning assessed at 5 and 12 months post-randomization. Outcomes will be analyzed using logistic and mixed effects regression. Discussion: The results from this study will provide evidence on whether treating comorbid anxiety in children with ADHD using a CBT approach leads to improvements in anxiety and/or broader functional outcomes. Trial registration: This trial was prospectively registered: Current Controlled Trials ISRCTN59518816 (10.1186/ISRCTN59518816). The trial was first registered 29/9/15 and last updated 15/1/19. [ABSTRACT FROM AUTHOR]