The CALM trial
Research type
Research Study
Full title
The CALM trial: the clinical and cost-effectiveness of a guided self-help cognitive behavioural therapy intervention to reduce dental anxiety in children
IRAS ID
305973
Contact name
Zoe Marshman
Contact email
Sponsor organisation
Sheffield Teaching Hospital Foundation NHS Trust
ISRCTN Number
ISRCTN27579420
Duration of Study in the UK
4 years, 0 months, 0 days
Research summary
This 4-year study is a multi-region, randomised controlled trial involving 600 children (aged 9-16 years), and where agreeable a parent/carer, in 30 primary dental care sites. A 12-month internal pilot will assess recruitment rates (of dental sites and participants) and engagement with the intervention, before progressing to the main trial. In each site, two dental professionals will take part, one randomly assigned to receive the Cognitive Behavioural Therapy (CBT) training and deliver the intervention and the other will deliver usual care. Children with dental anxiety (DA) attending these sites, 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, Oral Health Related Quality of Life (OHRQoL) and Health-related quality of life (HRQoL) before treatment, just after treatment completion and 12 months post-randomisation. Attendance rates, need for sedation/general anaesthesia (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 Child Health Utility-9D – a measure of child health-related quality of life (CHU9D) to generate utilities.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
22/EE/0013
Date of REC Opinion
11 Mar 2022
REC opinion
Further Information Favourable Opinion