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

MARSHMAN, Zoe, RODD, Helen, FAIRHURST, Caroline, PORRITT, Jenny, DAWETT, Bhupinder, DAY, Peter, INNES, Nicola, VERNAZZA, Christopher, NEWTON, Tim, RONALDSON, Sarah, CROSS, Liz, ROSS, Jennie, BAKER, Sarah R., HEWITT, Catherine, TORGERSON, David and AINSWORTH, Hannah (2023). The CALM trial protocol: a randomised controlled trial of a guided self-help cognitive behavioural therapy intervention to reduce dental anxiety in children. Trials, 24 (1): 15.

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Abstract

Background: Globally, around 13% of children experience dental anxiety (DA). This group of patients frequently miss dental appointments, have greater reliance on treatment under general anaesthesia (GA) and have poorer oral health-related quality of life (OHRQoL) than their non-dentally anxious peers. Recently, a low-intensity cognitive behavioural therapy (CBT)-based, self-help approach has been recommended for management of childhood anxiety disorders. A feasibility study conducted in secondary care found this guided self-help CBT resource reduced DA and a randomised controlled trial was recommended. The present study aims to establish the clinical and cost-effectiveness of a guided self-help CBT intervention to reduce DA in children attending primary dental care sites compared to usual care. Methods: This 4-year randomised controlled trial will involve 600 children (aged 9–16 years) and their parent/carers in 30 UK primary dental care sites. At least two dental professionals will participate in each site. They will be assigned, using random allocation, to receive the CBT training and deliver the intervention or to deliver usual care. Children with DA attending these sites, in need of treatment, will be randomly allocated to be treated either by the intervention (CBT) or control (usual care) dental professional. Children will complete questionnaires relating to DA, OHRQoL and HRQoL before treatment, immediately after treatment completion and 12 months post-randomisation. Attendance, need for sedation/GA and costs of the two different approaches will be compared. The primary outcome, DA, will be measured using the Modified Child Dental Anxiety Scale. Scores will be compared between groups using a linear mixed model. Discussion: Treating dentally anxious patients can be challenging and costly. Consequently, these children are frequently referred to specialist services for pharmacological interventions. Longer waiting times and greater travel distances may then compound existing healthcare inequalities. This research will investigate whether the intervention has the potential to reduce DA and improve oral health outcomes in children over their life-course, as well as upskilling primary dental healthcare professionals to better manage this patient group. Trial registration: This clinical trial has been registered with an international registry and has been allocated an International Standard Randomised Controlled Trial Number (ISRCTN27579420).

Item Type:	Article
Additional Information:	** 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
Uncontrolled Keywords:	Study Protocol, Child dental anxiety, Randomised clinical trial, Primary dental care, Cognitive behavioural therapy intervention, Behaviour management
Identification Number:	https://doi.org/10.1186/s13063-022-07046-6
SWORD Depositor:	Colin Knott
Depositing User:	Colin Knott
Date Deposited:	11 Jan 2023 11:45
Last Modified:	12 Oct 2023 08:15
URI:	https://shura.shu.ac.uk/id/eprint/31279

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