Minimising Young Children’s Anxiety through Schools (MY-CATS): statistical analysis plan for a cluster randomised controlled trial to evaluate the effectiveness and cost-effectiveness of an online parent-led intervention compared with usual school practice for young children identified as at risk for anxiety disorders

Abstract

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

Statistical analysis plan for a cluster randomised controlled trial to compare screening, feedback and intervention for child anxiety problems to usual school practice: identifying Child Anxiety Through Schools-identification to intervention (iCATS-i2i)

“…This approach, with blocking, was used to balance allocation on the potentially prognostic factor of FSM (deprivation) whilst ensuring a tight balance on the number of children allocated to each trial arm (which might not happen if school size was used as a stratification variable, categorised in some way). This method has been used in other cluster RCTs [ 16 – 18 ]. The programme for generating the randomisation sequence was written in R software [ 14 ] by SB and implemented by an independent statistician not otherwise involved in the trial.…”

Statistical analysis plan for a cluster randomised controlled trial to compare screening, feedback and intervention for child anxiety problems to usual school practice: Identifying Child Anxiety Through Schools – identification to intervention (iCATS-i2i)

“…This approach, with blocking, was used to balance allocation on the potentially prognostic factor of FSM (deprivation) whilst ensuring a tight balance on the number of children allocated to each trial arm (which might not happen if school size was used as a stratification variable, categorised in some way). This method has been used in other cluster RCTs [16][17][18]. The programme for generating the randomisation sequence was written in R software [14] by SB and implemented by an independent statistician not otherwise involved in the trial.…”

Curative care expenditure of outpatient anxiety disorder in Liaoning Province, 2015-2020-based on “System of Health Accounts 2011”

“…Previous studies in China have focused on epidemiology ( 14 , 15 ), examining the prevalence of anxiety disorders in different dimensions and in different provinces, and have not addressed anxiety disorder cost accounting and measured province-specific costs ( 16–23 ). Others focused on cost analyses of specific treatments [including cognitive-behavioral therapy ( 24–26 ), digital intervention therapies ( 27 ), and reception and commitment therapy ( 28 )], randomized controlled trials ( 29 ), specific types of anxiety disorders [generalized anxiety disorder ( 30 , 31 )], treatment with medications ( 32 , 33 ), and co-morbidities ( 2 , 34 , 35 ) were analyzed for costs. Although these studies help to promote the development of anxiety disorder cost analysis, there is currently no larger system representative sample or systematic accounting framework to account for anxiety disorder costs in a region, and having a systematic accounting framework to account for anxiety disorder costs can improve the accuracy of measurement and comparability between different countries.…”