The goal of this effectiveness trial is to investigate if an integrated dental habituation programme can enhance acceptance of a clinical dental examination in children (aged 5-8 years) with autism spectrum disorder (ASD). The main questions it aims to answer are: * Can a dental habituation programme performed by trained dental hygienists increase the acceptance of a clinical dental examination in children with ASD? * Is a dental habituation programme for children with ASD more effective compared to home preparation using visual aids performed by parents/guardians in increasing the acceptance of a clinical dental examination in children with ASD? The study participants will be randomly assigned to either the habituation group (intervention) or the home preparation group (augmented control) to investigate the effectiveness in increasing acceptance and cooperation of a clinical dental examination.
BACKGROUND Autism Spectrum Disorder (ASD) is a developmental disorder characterized by deviations in language, communication, social interaction, and a restricted and repetitive pattern of activities and interests. Good oral health is crucial for life satisfaction and impacts general health, nutrition, appearance, and communication. Several studies have shown that children with ASD often face challenges during oral examinations and dental treatments. Increased stress and anxiety in these patients also make dental treatment challenging for caregivers and the dental team. Various studies have demonstrated that communication aids, such as visual tools (pictures, books, films), and familiarization techniques (e.g., tell-show-do), can reduce stress and increase cooperation during dental examinations. Studies indicate that knowledge about ASD among healthcare professionals is limited. Despite continuous improvements, there is significant variation in knowledge levels across different age groups and professional backgrounds. A lack of knowledge and confidence in their skills among healthcare professionals can result in poorer healthcare services for children with ASD. Sufficient knowledge and early intervention are essential for achieving positive outcomes for this patient group. METHODS Design and Procedures: To address this challenge and enable more dental examinations at local clinics, the investigators have developed a training program for dental personnel. The course, developed by pediatric dentists, was presented to a resource group consisting of a psychologist, a dental hygienist, dentists, a researcher, and a parent of a child with ASD. Adaptations were made based on feedback from the resource group. The course includes both theoretical and practical content, focusing on ASD characteristics, communication techniques, and tools specific to this patient group to increase cooperation and the completion of clinical dental examinations. During the course, dental personnel will be trained in a habituation program to provide a gradual and structured approach to dental examinations, minimizing unwanted behavior and reducing perceived stress in the child, parent, and dental practitioner. To the effectiveness of the integrated habituation program will be evaluated in a randomized controlled trial. The intervention will last for 5 weeks, with one habituation session each week. The habituation sessions will be performed at selected dental clinics. Clinics will be selected based on geographical location, and on the affiliation of the dental hygienist participating in the study. Participants will be recruited from two counties in western Norway (Rogaland and Vestland) and randomly assigned to either the intervention group or an augmented control group. The augmented control group will receive a toolbox with visual aids for home preparation before a dental appointment, similar to the intervention group. Participation will be based on written informed consent provided by the parents og caregivers of the children. Measurements: The effects of the habituation program will be assessed based on the successful completion of a clinical dental examination. Additionally, changes in cooperation (using the Frankl scale) during each session will be recorded. Parents will be asked to fill out a mapping form at baseline, and clinical data from patient journals will be collected. Child stress will be measured using the Wong Baker FACES® scale. In addition, following the intervention, both parents and dental hygieneists will be invited to an interview to share their experiences as part of the evaluation of the study. Power and Sample Size: The estimation of sample size is based on a binary logistic model with a random effect factor. 1000 Monte Carlo simulations indicate that 225 children are needed to provide satisfactory power, given that the difference in the probability of success is not less than 0.2. However, there is uncertainty associated with the calculations since previous studies, which formed the basis for this calculation, differ from this study in several ways (e.g., different age and setting, different steps in the habituation program). It was calculated that at least 6 dental hygienists are needed to participate in the study and perform the habituation program. Data Analysis: The statistical software package SPSS (IBM) will be used to analyze quantitative data such as questionaire data, Frankl scale data, and clinical data from patient journals. The analyses will include descriptive statistics and statistical tests to identify changes and differences in the study variables within and between the intervention and control groups (e.g., t-tests, mixed-effects models). It is hypothesized that the use of the habituation program will lead to increased cooperation and completion of clinical dental examinations, and a reduction in child and parental stress in this setting. Regression analysis will be employed to investigate associations between study variables while adjusting for potential covariates. NVivo (Alfasoft) will be used to analyze additional qualitative data from patient journals.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
225
The habituation will be performed by dental hygenists working in the public dental service in Rogaland or Vestland counties. The dental hygenists have completed a 2-day educational course consisting of both theoretical and practical information specifically adressing dental examination of children with autism spectrum disorder. The habituation will be done at the dental office. The intervention consists of five structured habituation sessions with the trained dental hygienist where the different elements of a clinical dental examination will be introduced stepwise in a controlled manner. Parents/guardians will also receive a "toolbox" with visual aids and a dental examination mirror with instructions for use during home preparations prior to the habituation sessions.
Participants in the augmented control group will receive a "toolbox" with visual aids and a dental examination mirror. The parents/guardians of these participants will receive written information on how to use these tools at home to prepare for a clinical dental examination.
Oral health centre of Expertise Rogaland
Stavanger, Rogaland, Norway
RECRUITINGThe public dental health service Vestland Norway
Bergen, Vestland, Norway
RECRUITINGCompletion of a clinical dental examination with good cooperation
The dental examination has been divided into several steps (i.e., sitting in the chair, accepting examination with dental mirror, accepting light from the lamp, examination with probe). The primary objective will be completion of a clinical dental examination (examination with mirror and probe) with good cooperation. After 5 weeks (either with home preparation or habituation sessions) a blinded dental personell (untrained) will do a clinical dental examination (treatment as usual). Cooperation will be measured using the Frankl scale, reported by the parents/guardians for each step in the dental examination.
Time frame: 6 weeks after the first habituation session/home preparation
Changes in child stress measured by Wong-Baker FACES pain rating scale
Changes in child stress will be measured by Wong-Baker FACES pain rating scale. The children will be asked to indicate how they feel by pointing on one of the faces that best describe how they feel. If the child is not capable of performing this task, the parent/guardian will be asked to indicate on the scale how they perceive their child to feel at that moment. Children in the intervention group will be asked to do this at the first habituation session and at the post-test (approx. 6 weeks later). Children in the control group will only perform the rating once, at the post-test.
Time frame: At session 1, (only intervention group), after 6 weeks (intervention and control group)
Changes in cooperation assessed by Frankl scale
For the intervention group, cooperation during each habituation sessions will be monitored using the Frankl scale. Parents/guardians will be asked to fill out the form.
Time frame: Once per week for 5 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.