Autism Spectrum DisorderNCT06470724
Effectiveness of Visual-Behavioral Approach and Predictive Factors in Dental Exams for Children With Autism
A study testing Structural visual approach in people with Autism Spectrum Disorder, run by Universitas Muhammadiyah Yogyakarta at 1 site in Indonesia.
Trial summary
The objective of the study are: 1. Evaluating the effectiveness of the structural-visual model of behavioral approach on the compliance and cooperativity of children with ASD in dental examinations. 2. Analyzing the association between the predicting factors and compliance in the step of dental examination. 3. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Structural visual approach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteIndonesia
- Study dates
- 4 Oct 2021to 1 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Universitas Muhammadiyah Yogyakarta Dental Hospital
Yogyakarta, 55252
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Structural visual approach
- Keywords
- Autism spectrum Disorder,, visual pedagogy, structural, cooperativity, dental examination
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structural visual approachBehavioural
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 group | Role | What they receive |
|---|---|---|
| intervention of structural visual approach | Experimental | 1. st visit): Intervensi: Successive approaches, T-S-F-D, visual pedagogy
2. nd visit): Intervensi: Successive approaches, T-S-F-D, visual pedagogy, audio-visual modelling
3. rd visit): Intervensi: Successive approaches, T-S-F-D, visual pedagogy, in vivo modelling
4. th visit): Intervensi: Successive approaches, T-S-F-D, visual pedagogy, behavioral trials
5. th visit): Intervensi: T-S-F-D, auto-modeling, behavioral trial Receives: Behavioral: Structural visual approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance of dental step of examination
Compliance with dental step examination
These steps (a) through (j) were given scores from 1 to 10:
- Going into the dental room (score 1):
- Sitting down (score 2):
- Lying back in the dentist chair (score 3)
- Tolerating direct light on the face (score 4
- Mouth open wide and teeth showing (score 5)
- Being able to handle having your mouth touched with gloves on (score 6)
- Looking at yourself in the mirror (score 7)
- Check over with tooth explorer (score 8)
- Exam with bathroom mirror and tooth probe (score 9)
- Tooth blockage (score 10)
Measured: 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
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:
- Definitely Not Good The patient doesn't want to get treatment, cries, is scared, fights, and is very negative.
- Negative: Not wanting to get dental care, not following through, and having a negative attitude, but not too much.
- Good news The patients are willing to go to the doctor, don't mind any treatment, follow directions, and work together.
- Definitely positive Gets along well with the dentist, is interested in treatments, smiles, and seems to enjoy the situation.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start4 Oct 2021
- Primary completion23 Apr 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Intervention Day of Intervention Structural Intervention 1. st visit :Successive approaches,T-S-F-D,visual pedagogy 2. nd visitSuccessive approaches,T-S-F-D, visual pedagogy, audio-visual modelling 3. nd visit: Successive approaches, T-S-F-D, visual pedagogy, in vivo modelling 4. h visit: Successive approaches, T-S-F-D, visual pedagogy, behavioral trials 5. th visit:T-S-F-D, auto-modeling, behavioral trial The intervention in the process of dental examination lasted within 5 times of dental visit. During the pre-intervention test, the dentist asked the child to submit to the 10 steps of the dental examination but did not force the child to comply and cooperativity was measured by Frankl Behavior Scale, and the assessment/post-test was conducted 3 times. dentist explained the steps using photographs and images, and the assistant filmed this activity.
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Muhammadiyah Yogyakarta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alfini Octavia, Universitas Muhammadiyah Yogyakarta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06470724
- Sponsor's protocol ID
- 256/EC-KEPK FKIK UMY/IX/2021
- Status last verified
- Jun 2024
- First submitted
- 12 Jun 2024
- Last updated
- 24 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD is not shared with other parties because it is in accordance with the statement submitted in the ethics submission.
Publications
Elmore JL, Bruhn AM, Bobzien JL. Interventions for the Reduction of Dental Anxiety and Corresponding Behavioral Deficits in Children with Autism Spectrum Disorder. J Dent Hyg. 2016 Apr;90(2):111-20.
PubMed 27105789
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Structural-Visual Model Behavioral Approach and Predictive Factors of Cooperativity and Compliance in Dental Examinations for Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT06470724
- Acronym / sponsor ID
- 256/EC-KEPK FKIK UMY/IX/2021
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism spectrum Disorder,, visual pedagogy, structural, cooperativity, dental examination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Universitas Muhammadiyah YogyakartaUniversity, hospital or other
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 23 Apr 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 24 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Intervention Day of Intervention Structural Intervention 1. st visit :Successive approaches,T-S-F-D,visual pedagogy 2. nd visitSuccessive approaches,T-S-F-D, visual pedagogy, audio-visual modelling 3. nd visit: Successive approaches, T-S-F-D, visual pedagogy, in vivo modelling 4. h visit: Successive approaches, T-S-F-D, visual pedagogy, behavioral trials 5. th visit:T-S-F-D, auto-modeling, behavioral trial The intervention in the process of dental examination lasted within 5 times of dental visit. During the pre-intervention test, the dentist asked the child to submit to the 10 steps of the dental examination but did not force the child to comply and cooperativity was measured by Frankl Behavior Scale, and the assessment/post-test was conducted 3 times. dentist explained the steps using photographs and images, and the assistant filmed this activity.
| Arm | Type | Receives |
|---|---|---|
| intervention of structural visual approach | Experimental | Behavioral: Structural visual approach1. st visit): Intervensi: Successive approaches, T-S-F-D, visual pedagogy 2. nd visit): Intervensi: Successive approaches, T-S-F-D, visual pedagogy, audio-visual modelling 3. rd visit): Intervensi: Successive approaches, T-S-F-D, visual pedagogy, in vivo modelling 4. th visit): Intervensi: Successive approaches, T-S-F-D, visual pedagogy, behavioral trials 5. th visit): Intervensi: T-S-F-D, auto-modeling, behavioral trial |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structural visual approachThe 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. | Behavioural | intervention of structural visual approach |
Primary outcome
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: 1. Going into the dental room (score 1): 2. Sitting down (score 2): 3. Lying back in the dentist chair (score 3) 4. Tolerating direct light on the face (score 4 5. Mouth open wide and teeth showing (score 5) 6. Being able to handle having your mouth touched with gloves on (score 6) 7. Looking at yourself in the mirror (score 7) 8. Check over with tooth explorer (score 8) 9. Exam with bathroom mirror and tooth probe (score 9) 10. Tooth blockage (score 10)
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: 1. Definitely Not Good The patient doesn't want to get treatment, cries, is scared, fights, and is very negative. 2. Negative: Not wanting to get dental care, not following through, and having a negative attitude, but not too much. 3. Good news The patients are willing to go to the doctor, don't mind any treatment, follow directions, and work together. 4. Definitely positive Gets along well with the dentist, is interested in treatments, smiles, and seems to enjoy the situation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- Results publication: PubMed 27105789Elmore JL, Bruhn AM, Bobzien JL. Interventions for the Reduction of Dental Anxiety and Corresponding Behavioral Deficits in Children with Autism Spectrum Disorder. J Dent Hyg. 2016 Apr;90(2):111-20.
- Individual participant dataSharing planned: No. IPD is not shared with other parties because it is in accordance with the statement submitted in the ethics submission.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structural visual approach in people with Autism Spectrum Disorder, run by Universitas Muhammadiyah Yogyakarta at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06470724, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2024.