Characteristics and practices of school-based cluster randomised controlled trials for improving health outcomes in pupils in the UK: a systematic review protocol

Abstract

IntroductionCluster randomised trials (CRTs) are studies in which groups (clusters) of participants rather than the individuals themselves are randomised to trial arms. CRTs are becoming increasingly relevant for evaluating interventions delivered in school settings for improving the health of children. Schools are a convenient setting for health interventions targeted at children and the CRT design respects the clustered structure in schools (ie, pupils within classrooms/teachers within schools). Some of the methodological challenges of CRTs, such as ethical considerations for enrolment of children into trials and how best to handle the analysis of data from participants (pupils) that change clusters (schools), may be more salient for the school setting. A better understanding of the characteristics and methodological considerations of school-based CRTs of health interventions would inform the design of future similar studies. To our knowledge, this is the only systematic review to focus specifically on the characteristics and methodological practices of CRTs delivered in schools to evaluate interventions for improving health outcomes in pupils in the UK.Methods and analysisWe will search for CRTs published from inception to 30 June 2020 inclusively indexed in MEDLINE (Ovid). We will identify relevant articles through title and abstract screening, and subsequent full-text screening for eligibility against predefined inclusion criteria. Disagreements will be resolved through discussion. Two independent reviewers will extract data for each study using a prepiloted data extraction form. Findings will be summarised using descriptive statistics and graphs.Ethics and disseminationThis methodological systematic review does not require ethical approval as only secondary data extracted from papers will be analysed and the data are not linked to individual participants. After completion of the systematic review, the data will be analysed, and the findings disseminated through peer-reviewed publications and scientific meetings.PROSPERO registration numberCRD42020201792.

Characteristics and practices of school-based cluster randomised controlled trials for improving health outcomes in pupils in the United Kingdom: a methodological systematic review

“…The systematic review was registered with PROSPERO (CRD42020201792) and the protocol has been published [15]. After extensive scoping of the subject area, a pragmatic decision was made to search MEDLINE (through Ovid) in order to make the review more time-efficient and align with available resources.…”

Effects of Combined Movement and Storytelling Intervention on Fundamental Motor Skills, Language Development and Physical Activity Level in Children Aged 3 to 6 Years: Study Protocol for a Randomized Controlled Trial

“…The distribution of the class groups (12 class groups) will be in 3 experimental groups (6 class groups, n ± 72 children) and 3 control groups (6 class groups, n ± 72 children). The distribution by clusters or strata is justified by the fact that the use of individual randomization would imply a high probability of contaminating the control groups since it is unfeasible to prohibit children from interacting in school classrooms or recreational spaces (i.e., playgrounds, hallways, laboratories), which is where the study intervention will be carried out [ 18 , 19 ]. In addition, in the Maule region (one of the sixteen regions into which to Chile is divided; located in the center of the country and bordered to the north by the O’Higgins region, to the east by the provinces of Mendoza and Neuquén belonging to Argentina, to the south by the Ñuble region and to the west by the Pacific Ocean), there are 54 educational establishments that provide preschool education with an enrollment of approximately 1080 children.…”

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

“…Previous studies indicate 10-15% will score above the cut-off on each single screen (Bayer et al, [2]; Löwe et al, [26]; [39]); we estimate 20% will screen positive on at least one risk factor (from Hudson et al, [20]). The median intra-cluster (intra-school) correlation coefficient in a recent systematic review of school-based cluster randomised trials was 0.028 (Parker et al, [30]). Our assumed value of 0.05, therefore, leans on the side of caution.…”