Can we use a guided self-help cognitive behavioural therapy intervention to reduce dental anxiety in children?
| ISRCTN | ISRCTN27579420 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27579420 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 305973 |
| Protocol serial number | IRAS 305973 |
| Sponsor | Sheffield Teaching Hospitals NHS Foundation Trust |
| Funder | Health Technology Assessment Programme |
- Submission date
- 16/11/2021
- Registration date
- 17/11/2021
- Last edited
- 15/05/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
A visit to the dentist can make many children feel anxious. Children with dental anxiety (DA) have poor oral health (more dental 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.
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, but very limited evidence about CBT for children with dental anxiety delivered specifically by dental professionals, rather than by psychologists. 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 a hospital or community dental service (secondary care), there was a significant reduction in self-reported anxiety, improved attendance and less use of 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.
The aim of this 5-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.
Who can participate?
Children with DA aged 8 - 16 years, and their parents.
What does the study involve?
We will conduct a randomised controlled trial with an internal pilot based in primary care. Overall, 600 children with dental anxiety aged 8 - 16 years, who require a course of dental treatment, will be recruited from up to 40 dental practices/clinics 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 will then be randomly allocated to be treated by either the CBT dental professional or the non-CBT (control) dental professional. Children will complete questionnaires about outcomes including their dental anxiety and 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, the need for sedation/GA and the costs of the two different approaches.
What are the possible benefits and risks of participating?
The potential benefits for children and parents taking part will be a reduction in dental anxiety and improved quality of life. This is a low-risk study although we do appreciate that for children and parents talking about their anxieties can be difficult.
Where is the study run from?
Sheffield Teaching Hospitals NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
September 2021 to February 2026
Who is funding the study?
National Institute for Health Research (NIHR) (UK).
Who is the main contact?
Victoria Exley, victoria.exley@york.ac.uk
Liz Cross, e.a.cross@sheffield.ac.uk
Contact information
Scientific
Department of Health Sciences
University of York
Heslington
York
YO10 5DD
United Kingdom
 ORCID ID |
0000-0002-9326-9046 |
|---|---|
| Phone | +44 1904 326856 |
| victoria.exley@york.ac.uk |
Public
Room C04, School of Clinical Dentistry
Claremont Crescent
University of Sheffield
Sheffield
S10 2TA
United Kingdom
| ORCID ID |
0000-0002-7976-8463 |
|---|---|
| Phone | +44 7355 009986 |
| e.a.cross@sheffield.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multi-region individually randomized two-arm trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | The CALM trial: the clinical and cost-effectiveness of a guided self-help cognitive behavioural therapy intervention to reduce dental anxiety in children |
| Study acronym | CALM |
| Study objectives | What is the clinical and cost-effectiveness of a guided self-help cognitive behavioural therapy (CBT) intervention delivered to dentally anxious children by primary care dental professionals, compared to usual care? |
| Ethics approval(s) | Approved 11/03/2022, East of England - Cambridge South Research Ethics Committee (Equinox House, City Link, Nottingham, NG2 4LA; +44 (0)207 104 8084; cambridgesouth.rec@hra.nhs.uk), ref: 22/EE/0013 |
| Health condition(s) or problem(s) studied | Children’s dental anxiety |
| Intervention | Current interventions as of 15/05/2025: This 5-year study is a multi-region, randomised controlled trial involving 600 children (aged 8-16 years), and where agreeable a parent/carer, in up to 40 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 CBT training and deliver the intervention and the other will deliver usual care. Children with 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. The CBT involves a guided self-help CBT intervention ‘Your teeth, you are in control’ and accompanying parental resources delivered by the primary care 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. Randomisation: Within each dental site, at least two dental professionals will be involved; one dental professional will be randomly assigned to receive the training and deliver the intervention; and the other to deliver usual care. Randomisation of children will be 1:1 and stratified by site using variable block sizes. The randomisation sequences will be generated by an independent trial statistician at the York Trials Unit (YTU). Children will be randomised via the secure, remote web or telephone-based randomisation service at YTU. _____ Previous interventions as of 25/07/2023: This 4-year study is a multi-region, randomised controlled trial involving 600 children (aged 8-16 years), and where agreeable a parent/carer, in up to 40 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 CBT training and deliver the intervention and the other will deliver usual care. Children with 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. The CBT involves a guided self-help CBT intervention ‘Your teeth, you are in control’ and accompanying parental resources delivered by the primary care 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. Randomisation: Within each dental site, at least two dental professionals will be involved; one dental professional will be randomly assigned to receive the training and deliver the intervention; and the other to deliver usual care. Randomisation of children will be 1:1 and stratified by site using variable block sizes. The randomisation sequences will be generated by an independent trial statistician at the York Trials Unit (YTU). Children will be randomised via the secure, remote web or telephone-based randomisation service at YTU. _____ Previous interventions: 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 CBT training and deliver the intervention and the other will deliver usual care. Children with 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. The CBT involves a guided self-help CBT intervention ‘Your teeth, you are in control’ and accompanying parental resources delivered by the primary care 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. Randomisation: Within each dental site, at least two dental professionals will be involved; one dental professional will be randomly assigned to receive the training and deliver the intervention; and the other to deliver usual care. Randomisation of children will be 1:1 and stratified by site using variable block sizes. The randomisation sequences will be generated by an independent trial statistician at the York Trials Unit (YTU). Children will be randomised via the secure, remote web or telephone-based randomisation service at YTU. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Dental anxiety measured using the Modified Child Dental Anxiety Scale (MCDAS) score at 12 months post-randomisation |
| Key secondary outcome measure(s) |
1. Dental anxiety (MCDAS) measured at the end of the course of treatment. |
| Completion date | 28/02/2026 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Child |
| Lower age limit | 8 Years |
| Upper age limit | 16 Years |
| Sex | All |
| Target sample size at registration | 1080 |
| Total final enrolment | 467 |
| Key inclusion criteria | Current inclusion criteria as of 25/07/2023: Child: 1. Patients aged 8-16 years, inclusive 2. Child self-reported dental anxiety 3. Not requiring urgent dental treatment 4. Attending for a dental assessment and found to require a course of treatment for their presenting dental condition (categorised as level one complexity by NHS England), involving at least two additional visits and within the scope of practice of the CALM dental professional 5. Child able to read and use written English, required to receive the intervention and complete questionnaires Parent/Carer: 1. Parent/carer able to complete consent forms (with the support of an interpreter if necessary) _____ Previous inclusion criteria as of 23/11/2022: Child: 1. Patients aged 9-16 years, inclusive 2. Child self-reported dental anxiety 3. Not requiring urgent dental treatment 4. Attending for a dental assessment and found to require a course of treatment for their presenting dental condition (categorised as level one complexity by NHS England), involving at least two additional visits and within the scope of practice of the CALM dental professional 5. Child able to read and use written English, required to receive the intervention and complete questionnaires Parent/Carer: 1. Parent/carer able to complete consent forms (with the support of an interpreter if necessary) _____ Previous inclusion criteria: Child: 1. Patients aged 9-16 years, inclusive 2. Attending for a dental assessment and found to require a course of treatment for their presenting dental condition (categorised as level one complexity by NHS England), involving at least two additional visits 3. Not requiring urgent dental treatment 4. Child able to read and use written English, required to receive the intervention and complete questionnaires 5. Child self-reported dental anxiety based on a screening question. Parent: 1. Parent/carer able to complete consent forms (with the support of an interpreter if necessary) |
| Key exclusion criteria | Current exclusion criteria as of 25/07/2023: Child: 1. Patients younger than 8 years or older than 16 years 2. A sibling of a child patient recruited to the trial 3. No self-reported dental anxiety 4. Seen for an assessment with an acute presentation and in need of immediate dental treatment 5. Have previously been seen for an assessment and part-way through a prescribed course of dental treatment 6. Seen for an assessment but not requiring more than one further visit to complete any necessary treatment 7. Requiring procedures during the course of treatment that fall outside of the scope of the practice of the dental professionals involved 8. Requiring referral to a specialist for more complex treatment needs (categorised as level two or three complexity by NHS England) 9. Child unable to read and use written English Parent/Carer: 1. Parent /carer unable to complete consent forms (even with support). _____ Previous exclusion criteria as of 23/11/2022: Child: 1. Patients younger than 9 years or older than 16 years 2. A sibling of a child patient recruited to the trial 3. No self-reported dental anxiety 4. Seen for an assessment with an acute presentation and in need of immediate dental treatment 5. Have previously been seen for an assessment and part-way through a prescribed course of dental treatment 6. Seen for an assessment but not requiring more than one further visit to complete any necessary treatment 7. Requiring procedures during the course of treatment that fall outside of the scope of the practice of the dental professionals involved 8. Requiring referral to a specialist for more complex treatment needs (categorised as level two or three complexity by NHS England) 9. Child unable to read and use written English Parent/Carer: 1. Parent /carer unable to complete consent forms (even with support). _____ Previous exclusion criteria: Child: 1. Patients younger than 9 years or older than 16 years 2. Have previously been seen for an assessment and part-way through a prescribed course of dental treatment 3. Seen for an assessment but not requiring more than one further visit to complete any necessary treatment 4. Seen for an assessment with an acute presentation and in need of immediate dental treatment 5. Requiring referral to a specialist for more complex treatment needs (categorised as level two or three complexity by NHS England) 6. Child unable to read and use written English Parent: 1. Parent/carer unable to complete consent forms (even with support) |
| Date of first enrolment | 01/05/2022 |
| Date of final enrolment | 28/03/2025 |
Locations
Countries of recruitment
- United Kingdom
- England
- Wales
Study participating centres
Worsley Building
Clarendon Way
Leeds
LS2 9LU
United Kingdom
Framlington Place
Newcastle
NE2 4BW
United Kingdom
ARRC Building
York
YO10 5DD
United Kingdom
Heath Park
Cardiff
CF14 4XY
United Kingdom
Claremont Crescent
Sheffield
S10 2TA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The dataset generated and analysed during the trial will be made available upon request from Professor Zoe Marshman, Z.Marshman@sheffield.ac.uk, who will consider requests on a case by case basis. The dataset will include anonymised quantitative and qualitative data from the trial and embedded process evaluation. The data will be available following publication of the trial results (01/09/2026). Participants have been made aware (in Participant Information Sheets) that information collected may be shared with other researchers for research purposes only, in an anonymised form. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 06/01/2023 | 09/01/2023 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Other publications | Your Teeth, You Are in Control: A Process Evaluation of the Implementation of a Cognitive Behavioural Therapy Intervention for Reducing Child Dental Anxiety | 10/01/2025 | 20/01/2025 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | version 3.0 | 07/06/2022 | 23/11/2022 | No | No |
| Protocol file | version 4.0 | 03/07/2023 | 25/07/2023 | No | No |
| Protocol file | version 6.0 | 28/03/2025 | 15/05/2025 | No | No |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- 40680 CALM Protocol v3.0 07June2022.pdf
- Protocol file
- ISRCTN27579420 CALM Protocol v4.0 03.07.2023.pdf
- Protocol file
- ISRCTN27579420_Protocol_v6.0_28March2025.pdf
- Protocol file
Editorial Notes
15/05/2025: The following changes were made:
1. Protocol version 6.0 uploaded.
2. Interventions were changed.
3. Total final enrolment added.
19/03/2025: The recruitment end date was changed from 28/02/2025 to 28/03/2025.
20/01/2025: Publication reference added.
06/08/2024: The following changes were made to the study record:
1. The recruitment end date was changed from 31/08/2024 to 28/02/2025.
2. The overall study end date was changed from 01/09/2025 to 28/02/2026.
01/05/2024: The recruitment end date was changed from 01/05/2024 to 31/08/2024.
25/07/2023: The following changes were made to the trial record:
1. Uploaded protocol v4.0 (not peer-reviewed) as an additional file.
2. The interventions were changed.
3. The inclusion criteria were changed.
4. The exclusion criteria were changed.
5. The plain English summary was updated to reflect these changes.
09/01/2023: Publication reference added.
23/11/2022: The following changes were made to the trial record:
1. Uploaded protocol (not peer-reviewed) as an additional file.
2. The inclusion criteria were changed.
3. The exclusion criteria were changed.
4. The recruitment start date was changed from 01/06/2022 to 01/05/2022.
5. The participant inclusion criteria: Age group was changed from 'Mixed' to 'Child'.
21/11/2022: A scientific contact was changed.
17/11/2022: A scientific contact was added.
11/05/2022: The following changes have been made:
1. The recruitment start date has been changed from 01/05/2022 to 01/06/2022.
2. The ethics approval has been added.
02/03/2022: The following changes have been made:
1. The recruitment start date has been changed from 01/03/2022 to 01/05/2022.
2. The recruitment end date has been changed from 01/03/2024 to 01/05/2024.
16/11/2021: Trial's existence confirmed by the National Institute for Health Research (NIHR) (UK).
