- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06470724
Effectiveness of Visual-Behavioral Approach and Predictive Factors in Dental Exams for Children With Autism
Effectiveness of Structural-Visual Model Behavioral Approach and Predictive Factors of Cooperativity and Compliance in Dental Examinations for Children With Autism Spectrum Disorder
The objective of the study are:
- Evaluating the effectiveness of the structural-visual model of behavioral approach on the compliance and cooperativity of children with ASD in dental examinations.
- Analyzing the association between the predicting factors and compliance in the step of dental examination.
- Analyzing the association between the predicting factors and cooperativity in dental examinations.
This study tested two hypotheses:
- Evaluating the effectiveness of the structural-visual model of behavioral approach on the compliance
- Evaluating the effectiveness of the structural-visual model of behavioral approach on cooperativity of children with ASD in dental examinations.
The participants will undergo the structural visual approach intervention, and the investigator will measure its effectiveness through four assessments: one pre-test and three post-tests.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Autism Spectrum Disorder (ASD) is a brain development disorder marked by issues in two main areas: communication and interacting with others; as well as rigid, repetitive, and stereotypical behaviors, hobbies, or activities. Autism Spectrum Disorder (ASD) is becoming more common every year, making it a major concern for most parents around the world, including those in Indonesia. One of the areas in Indonesia, Yogyakarta, also has to deal with this problem.
Studies have shown that a lot of kids with autism are afraid of things that don't make sense. Sensory issues are common in kids with ASD, which makes it hard for them to handle the sounds and sights in the dentist's office. As a result, these kids often show more behavioral problems, too much worry, and bad behavior at the dentist's office, which makes it very hard for the dentists to do exams and provide oral care. Researchers also think that this refusal to cooperate makes parents hesitant to take their autistic children to the dentist for regular checkups or treatments. This means that these kids don't get the dental care they need and have bad mouth health. Also, many studies show that kids with ASD are more likely than kids in the general population to have cavities, bad oral health, and periodontal disease.
To help people with behavior problems, you need to know about their other health problems, the type of ASD they have, any previous treatment they've had, their behavior, their social and communication skills, the medicines they take to control their behavior, any learning disabilities or mental retardation they may have, their heightened sensory perceptions, and their inability to apply what they have learned in other situations.
Notably, visual pedagogy is a structural-visual behavior method that is often used with kids who have ASD. People in Indonesia have looked into how to help kids with autism understand dental checks by using visual aids. However, these tests were not done in real centers with lots of kids and long wait times. With this and other reasons in mind, this study used a visual-structural method to help Indonesian kids with autism during dental checks. What they learned about kids and their families led them to make changes. The information can help dentists handle kids with ASD and guess how they will act during dental exams.
The intervention comprised seven behavior approaches in this research defined as follows:
A successive approach: An approach to familiarization with the unfamiliar environment of the simulated dental office.
Tell-Feel-Show-Do (T-F-S-D): A dental approach explained to the patient's treatment by telling the patient what would happen, what he felt or did, and what had been done.
Visual pedagogy: Introduced dentistry to autistic children through visual media, such as pictures and photographs.
Audiovisual modeling: A learning process through audiovisual media, such as video and animation.
In-vivo modeling: Learning new activities by watching them in front of the model.
Behavioral trials: A learning strategy conducted through practicing the recent activity by him/herself.
Auto-modeling: A learning process following the activity of editing pictures during the prior visit of the patient.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Yogyakarta, Indonesia, 55252
- Universitas Muhammadiyah Yogyakarta Dental Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged between 6 and 18 years old (school-aged children in Indonesia).
- Good general health without physical disabilities.
- Cooperative parents/caregivers who provided informed consent to participate in the study.
- They reside in the same household as their parents/caregivers.
- Diagnosis of autism spectrum disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) by a psychiatrist.
Exclusion Criteria:
- a. Had undergone training for dental examination in a dental setting. b. The dental approach could not be provided due to a lack of non-pharmacological behavior management or cooperative behavior.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: intervention of structural visual approach
|
The intervention comprised seven behavior approaches in this research defined as follows: A successive approach: An approach to familiarization with the unfamiliar environment of the simulated dental office. Tell-Feel-Show-Do (T-F-S-D): A dental approach explained to the patient's treatment by telling the patient what would happen, what he felt or did, and what had been done. Visual pedagogy: Introduced dentistry to autistic children through visual media, such as pictures and photographs. Audiovisual modeling: A learning process through audiovisual media, such as video and animation. In-vivo modeling: Learning new activities by watching them in front of the model. Behavioral trials: A learning strategy conducted through practicing the recent activity by him/herself. Auto-modeling: A learning process following the activity of editing pictures during the prior visit of the patient. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Compliance of dental step of examination
Time Frame: The duration of the research process spanned a period of 3 months. 1. The initial visit was pre-tested to assess the degree of cooperativity. 2. The second through sixth visits were conducted with a one-week gap. This is a visit for intervention, l
|
Compliance with dental step examination These steps (a) through (j) were given scores from 1 to 10:
|
The duration of the research process spanned a period of 3 months. 1. The initial visit was pre-tested to assess the degree of cooperativity. 2. The second through sixth visits were conducted with a one-week gap. This is a visit for intervention, l
|
|
Cooperativity
Time Frame: The duration of the research process spanned a period of 3 months. 1. The initial visit was pre-tested to assess the degree of cooperativity. The second through sixth visits were conducted with a one-week gap. This is a visit for intervention, last
|
During pre- and post-tests, the Frankl Behavior Scale was used to measure how cooperative the kids were. According to Frankl (1962) and Klein (1999), the scale was split into four groups:
|
The duration of the research process spanned a period of 3 months. 1. The initial visit was pre-tested to assess the degree of cooperativity. The second through sixth visits were conducted with a one-week gap. This is a visit for intervention, last
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 256/EC-KEPK FKIK UMY/IX/2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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