The CALM trial protocol: a randomised controlled trial of a guided self-help cognitive behavioural therapy intervention to reduce dental anxiety in children

** From Springer Nature via Jisc Publications Router ** Licence for this article: http://creativecommons.org/licenses/by/4.0/ ** Acknowledgements: Acknowledgements: We would like to thank all the participating dental professionals who have been so enthusiastic about this trial. We would also like to acknowledge the input of our young person co-applicant Tom Amanuel, and our PPIE representative co-applicant, Di Charles. The support of our two expert advisors, Professor Cathy Creswell, University of Oxford and Professor Chris Williams, University of Glasgow, is also greatly valued. The role of the Trial Steering Committee, the Data Monitoring and Ethics Committee and the administrative support of Jonathan Wake is also recognised. Authors’ contributions {31b}: ZM is the Chief Investigator, she conceived the study and led the proposal and protocol development. HDR, NI, PD and CV contributed to the study design and the proposal development particularly from a paediatric dentistry trial perspective. CF was the lead statistician. JP, SRB and TN contributed to the study design and the proposal development regarding the intervention and assessment of dental anxiety. SR was the lead health economist. BD and JR contributed to the design of the study in primary dental care. HA led the development of the trial methodology with contributions to the design from LC, CH and DT. All authors read and approved the final manuscript. Funding {4}: This study is funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) NIHR131805. The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. The funding body itself will not be involved in the undertaking or reporting of the study. It will however take a key monitoring role, to ensure that the study progresses satisfactorily according to the given timelines. Two of the authors of this paper (Peter Day and Zoe Marshman) are supported by the NIHR Applied Research Collaborations Yorkshire and Humber (NIHR ARC YH) NIHR200166 www.arc-yh.nihr.ac.uk. The views expressed in this publication are those of the author(s) and not necessarily those of the NIHR, the NHS or the Department of Health and Social Care. Availability of data and materials {29}: The dataset generated and analysed during the trial will be made available upon request from the CI. The data will be available following publication of the trial results. **Journal IDs: eissn 1745-6215 **Article IDs: publisher-id: s13063-022-07046-6; manuscript: 7046 **History: collection 12-2023; online 06-01-2023; published 06-01-2023; accepted 20-12-2022; registration 20-12-2022; submitted 10-11-2022