Clinical trial NCT06933342: ASD and Habituation to Dental Examination
Official title: Evaluating an Integrated Habituation Programme for Enhancing Dental Examination Acceptance in Children With Autism Spectrum Disorder: An Effectiveness Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Oral Health Training
Habituation
Autism Spectrum Disorder
Keywords: autism spectrum disorder
ASD
Dental examination
Dental habituation programme
Habituation
Oral health training
Lead sponsor: Oral Health Center of Expertise Rogaland, Norway
Sponsor class: OTHER
Collaborators: name: University of Oslo
name: The public dental health service Vestland Norway
name: Oral Health Centre of Expertise in Western Norway
name: The public dental health service Rogaland Norway
First posted: 2025-04-18
Enrollment: 225
Sex: ALL
Minimum age (years): 5
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A pragmatic randomized controlled trial will be employed to assess the effectiveness of a habituation program for children with autism spectrum disorders to enhance cooperation between the child and the dental hygienist and to enable a dental examination at a local dental clinic. Children will be assigned to either a habituation group (five habituation sessions) or to a control group receiving a "toolbox" with visual aids for preaparations at home.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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. Parental stress will be assessed at baseline and after the intervention. Child stress will be measured using the Wong Baker FACES® scale.

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.

Eligibility criteria: Inclusion Criteria:

* Children living in the counties Rogaland or Vestland, Norway
* English or Norwegian speaking
* Have not been able to complete a clinical dental examination at the local dental clinic
* Has an autism spectrum diagnosis (reported by parents/guardians)

Exclusion Criteria:

* Children not living in the counties Rogaland or Vestland, Norway
* Does not speak English or Norwegian
* Have completed a dental examination at the local dental clinic
* Have other severe developmental cognitive disabilites (in addition to an autism spectrum diagnosis) (reported by parents/guardians)

Primary outcomes:
measure: Completion of a clinical dental examination with good cooperation
timeFrame: 6 weeks after the first habituation session/home preparation
Secondary outcomes:
measure: Changes in child stress measured by Wong-Baker FACES pain rating scale
timeFrame: At session 1, (only intervention group), after 6 weeks (intervention and control group)
measure: Changes in cooperation assessed by Frankl scale
timeFrame: Once per week for 5 weeks
Other outcomes:
measure: Mapping questionnaire
timeFrame: Day 0
measure: Oral health status measured by DMFT
timeFrame: Day 0
measure: Oral hygiene measured by BSI or equivalent measurement
timeFrame: At the last habituation session (session 5), week 5
measure: Interview with dental hygienist's to gain their experiences with participating in the study
timeFrame: Periprocedural, within 2-3 months
measure: Interveiw with parent's to evaluate the study (habituation programme and home training)
timeFrame: Periprocedural, within 2-3 months
Locations:
city: Stavanger
country: Norway
facility: Oral health centre of Expertise Rogaland
state: Rogaland
Study officials:
affiliation: Oral health centre of expertise - Rogaland, Norway
name: Lene Elisabeth Myhren, PhD
role: PRINCIPAL_INVESTIGATOR
References: