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
dc.contributor.author | Jones, BG | |
dc.contributor.author | Reardon, T | |
dc.contributor.author | Creswell, C | |
dc.contributor.author | Dodd, HF | |
dc.contributor.author | Hill, C | |
dc.contributor.author | Jasper, B | |
dc.contributor.author | Lawrence, PJ | |
dc.contributor.author | Morgan, F | |
dc.contributor.author | Rapee, MR | |
dc.contributor.author | Violato, M | |
dc.contributor.author | Placzek, A | |
dc.contributor.author | Ukoumunne, OC | |
dc.date.accessioned | 2022-11-11T14:55:10Z | |
dc.date.issued | 2022-12-28 | |
dc.date.updated | 2022-11-11T14:34:43Z | |
dc.description.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 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. | en_GB |
dc.description.sponsorship | Kavli Trust | en_GB |
dc.description.sponsorship | UKRI | en_GB |
dc.description.sponsorship | National Institute for Health and Care Research (NIHR) | en_GB |
dc.identifier.citation | Vol. 23, article 1054 | en_GB |
dc.identifier.doi | 10.1186/s13063-022-06899-1 | |
dc.identifier.grantnumber | MR/S017909/1 | en_GB |
dc.identifier.uri | http://hdl.handle.net/10871/131744 | |
dc.identifier | ORCID: 0000-0002-0551-9157 (Ukoumunne, Obioha) | |
dc.language.iso | en | en_GB |
dc.publisher | BMC | en_GB |
dc.rights | © The Author(s) 2022. Open Access. This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. | |
dc.subject | Statistical analysis plan | en_GB |
dc.subject | Cluster randomised trial | en_GB |
dc.subject | school-based | en_GB |
dc.subject | anxiety | en_GB |
dc.subject | clustering | en_GB |
dc.subject | random effects | en_GB |
dc.subject | mediation | en_GB |
dc.title | 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 | en_GB |
dc.type | Article | en_GB |
dc.date.available | 2022-11-11T14:55:10Z | |
dc.identifier.issn | 1745-6215 | |
dc.description | This is the final version. Available on open access from BMC via the DOI in this record | en_GB |
dc.description | Availability of data and materials: Datasets and study materials generated during the current study will be made available in a public repository | en_GB |
dc.identifier.journal | Trials | en_GB |
dc.rights.uri | https://creativecommons.org/licenses/by/4.0/ | en_GB |
dcterms.dateAccepted | 2022-11-08 | |
dcterms.dateSubmitted | 2022-04-11 | |
rioxxterms.version | VoR | en_GB |
rioxxterms.licenseref.startdate | 2022-11-08 | |
rioxxterms.type | Journal Article/Review | en_GB |
refterms.dateFCD | 2022-11-11T14:34:46Z | |
refterms.versionFCD | AM | |
refterms.dateFOA | 2023-04-05T12:54:19Z | |
refterms.panel | A | en_GB |
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regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this
licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.