Title: The CALM trial: the clinical and cost-effectiveness of a guided self-help cognitive behavioural therapy intervention to reduce dental anxiety in children
Funder: Department of Health and Social Care

Abstract: A visit to the dentist can make many children feel anxious. Children with dental anxiety have poor oral health (more tooth decay and extractions) and may have a lifetime of avoiding the dentist. Dentists themselves find it stressful to treat children who feel anxious and frequently refer them to specialist services for sedation or general anaesthetic (GA). This has additional costs to the NHS and a burden to the family. A simple and cost-effective way of helping dentally anxious children is needed._x000D_ _x000D_ In 2015, NIHR funded a study to develop an intervention to reduce children’s dental anxiety based on guided self-help cognitive behavioural therapy (CBT). There is strong evidence to support the use of CBT, a ‘talking therapy’, for other forms of anxiety and mental health conditions. There is limited evidence about CBT delivered specifically by dental professionals, rather than by psychologists for children with dental anxiety. Guided self-help CBT resources were developed (hard copy and online) for children aged 9-16 years. The resources help children understand what makes them anxious, provide dental information, suggest strategies for reducing anxiety and coping better, encourage reflection and support better communication. When used with 48 dentally anxious children, referred to hospital or community dental service (secondary care), there was a reduction in self-reported dental anxiety, improved dental attendance and less need for GA. There is now a need to find out if it works in general dental practice (primary care) where the vast majority of children are seen._x000D_ _x000D_ The aim of this 4-year study is to compare the clinical and cost-effectiveness of a guided self-help CBT intervention delivered to dentally anxious children by primary care dental professionals compared to ‘usual’ care. We will investigate the effects on children’s dental anxiety, quality of life, dental attendance and the need for specialist services. We will also compare the cost and feasibility of this approach compared to usual care._x000D_ _x000D_ We will conduct a randomised controlled trial with an internal pilot. Overall, 600 children with dental anxiety aged 9-16 years will be recruited from 30 dental practices across the UK. In each dental practice there will be two dental professionals taking part; one will be randomly assigned to receive the training and deliver the intervention and the other will deliver usual care. Children with dental anxiety attending these practices, who need treatment (and consent to take part) will be randomly allocated to be treated by either the CBT-trained dental professional or the non CBT-trained (control) dental professional. Children will complete questionnaires about outcomes including their dental anxiety, oral health and general health-related quality of life before treatment, just after treatment completion and 12 months later to allow a comparison between the two groups. We will also compare attendance rates, need for sedation/GA and the costs of each approach. The feasibility of the trial will be considered one year after recruitment starts, and the trial will be stopped if we have not met agreed targets. A process evaluation will also be conducted._x000D_ _x000D_ We have worked with children, parents and PPI members to develop the study. We will share our findings widely with guideline developers, policy-makers, dental professionals and the public through publications, conference presentations, social media and public events.

Lay abstract: Globally, around 13% of children are reported to experience dental anxiety (DA) and its associated negative impacts for the individual, their family and dental team. Children with DA frequently miss dental appointments, even when experiencing symptoms, consequently having poorer oral health and oral health-related quality of life (OHRQoL) than their non-anxious peers. Each year, thousands of children with DA are referred from primary dental care to secondary care to complete treatment. In 2018/19 there were 59,011 paediatric admissions to hospital for dental extractions costing around £50 million. In recent years, a low intensity cognitive behavioural therapy (CBT) based self-help approach has been recommended for management of childhood anxiety disorders. In 2015, NIHR funded the development and feasibility study of a guided self-help CBT resource to reduce DA in children referred to secondary care. The study confirmed key feasibility parameters and when used with 48 children, the guided self-help CBT approach reduced self-reported DA, improved OHRQOL, improved attendance and reduced need for general anaesthesia (GA). The effectiveness of this approach when delivered in primary dental care to reduce children’s DA, now warrants investigation. _x000D_ Aims and objectives_x000D_ The aim is to establish the clinical and cost-effectiveness of a guided self-help CBT intervention to reduce DA in children attending primary dental care settings across the UK, compared to usual care._x000D_ Objectives are to: conduct an internal pilot trial; determine effects of the intervention on DA, HRQoL, secondary care referrals, attendance and cost-effectiveness; undertake a process evaluation._x000D_ Study design and timeline_x000D_ This 4-year study is a multi-region, randomised controlled trial involving 600 children (aged 9-16 years) in 30 dental practices. A 12-month internal pilot will assess recruitment rates (of dental practices and participants) and engagement with the intervention, before progressing to the main trial. In each dental practice two dental professionals will take part, one randomly assigned to receive the CBT training and deliver the intervention and the other will deliver usual care. Children with DA attending these practices, in need of treatment, will be randomly allocated to be treated by the CBT dental professional or the control dental professional. Children will complete questionnaires relating to DA, OHRQoL and HRQoL before treatment, just after treatment completion and 12 months post-randomisation. Attendance rates, need for sedation/GA and the costs of the two different approaches will be compared. The primary outcome, DA, will be measured using the Modified Child Dental Anxiety Scale (MCDAS); scores will be compared between groups using a covariance pattern linear mixed model, adjusting for baseline value, other pertinent baseline covariates, time, and an interaction between treatment group and time as fixed effects. A cost-utility analysis will estimate the mean differences in costs and quality-adjusted life years (QALYs), using the CHU9D to generate utilities. _x000D_ Impact and dissemination_x000D_ The study will inform future guidelines, clinical practice and commissioning decisions for the management of children with DA. Findings will be published in high impact, peer-reviewed dental journals and presented at scientific meetings. A trial website with social media accounts will ensure patient and public accessibility to the study’s progress.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MENTAL HEALTH;ORAL AND GASTROINTESTINAL