Child AutismNCT04576559
Effect of Modified Dental Visual Aids on Behavior Management During Dental Treatment in Children With Autism Spectrum Disorder
A study testing Modified dental visual aids and Regular dental visual aids in people with Child Autism, run by King Abdulaziz University at 1 site in Saudi Arabia.
Trial summary
There is a need to find an approach that is appropriate for managing children with Autism Spectrum Disorder in the dental clinic, to manage their behaviour and decrease their anxiety in this research we will apply our modified dental visual aids and test its effectiveness in managing the behavior of such children… Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Child Autism
- What is being tested?
- Modified dental visual aids and Regular dental visual aids
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Sep 2019to 30 Aug 2021
- 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 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient age between 6-10 years.
- Child patient has to represent the typical triad symptoms of ASD that include: social interaction deficits, communication impairment, language impairment and rigidity of interests.
- Child patient with ASD diagnosis confirmed in the patient's files according to "the DSM-V criteria" (American Psychiatric Association, 2013).
- Child patient with mild to moderate ASD according to "the Childhood Autism Rating Scale (CARS)" (Schopler et al., 1998).
Who cannot join
- Patient age younger than 6 years and older than 10 years.
- Child patient with other congenital anomalies, for example, "Cerebral Palsy" or "Down Syndrome".
- Child patient with previous dental experience.
- Child patient with severe ASD according to "the Childhood Autism Rating Scale (CARS)" (Schopler et al., 1998).
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
King Abdulaziz University
Jeddah, Select A State Or Province, 21589
About this study
There is a need to find an approach that is appropriate for managing children with Autism Spectrum Disorder in the dental clinic, to manage their behaviour and decrease their anxiety in this research we will apply our modified dental visual aids and test its effectiveness in managing the behavior of such children during the dental appointment.
- Conditions
- Child Autism
- Being tested
- Modified dental visual aids, Regular dental visual aids
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified dental visual aidsOther
Modified Dental visual aids in the form of pictures created by the main investigator
Regular dental visual aidsOther
Regular dental visual aids
| Study group | Role | What they receive |
|---|---|---|
| Modified dental visual aids | Experimental | Not described Receives: Other: Modified dental visual aids |
| Regular dental visual aids | Active comparator | Not described Receives: Other: Regular dental visual aids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque Index Scoring
plaque index scoring (Silness and Löe, 1964)
Measured: four weeks
Anxiety Scale for Children with Autism Spectrum Disorder (ASC-ASD)
This scale contains twenty-four "self-report" questions that inquire about anxiety, it contains 4 sub-scales including:
- Separation Anxiety (SA).
- Uncertainty (U).
- Performance Anxiety (PA).
- Anxious Arousal (AA). It is a four-point "Likert-scale"; items in the questionnaire are rated from zero ("never") to three ("always"). Another version of the same scale with twenty-four questions directed to the parents will also be used and it contains a report of their child's symptoms of anxiety, within the same four subscales (Rodgers et al., 2016).
Measured: four weeks
The Observational Scale of Behavioral Distress (OSBD)
This scale is used to measure the behavioral distress that a child experiences when undergoing a painful procedure. This scale is composed of eight operationally defined behaviors that are indicative of anxiety and/or pain behavior in children. The OSBD is a valid and reliable scale that measures distress in children receiving painful procedures in the medical and dental practice, for example, venipuncture and needle injections (Elliot et al., 1987).
Measured: four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2020
- Study start1 Sep 2019
- Primary completion1 Jul 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child AutismStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ala Aljubour, King Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04576559
- Sponsor's protocol ID
- KingAbdulazizUni
- Status last verified
- Aug 2022
- First submitted
- 30 Sep 2020
- Last updated
- 17 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Modified Dental Visual Aids on Behavior Management During Dental Treatment in Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT04576559
- Acronym / sponsor ID
- KingAbdulazizUni
- Conditions
- Child Autism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 6 Oct 2020 (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.
There is a need to find an approach that is appropriate for managing children with Autism Spectrum Disorder in the dental clinic, to manage their behaviour and decrease their anxiety in this research we will apply our modified dental visual aids and test its effectiveness in managing the behavior of such children during the dental appointment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified dental visual aids | Experimental | Other: Modified dental visual aids |
| Regular dental visual aids | Active comparator | Other: Regular dental visual aids |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patient age between 6-10 years.
- Child patient has to represent the typical triad symptoms of ASD that include: social interaction deficits, communication impairment, language impairment and rigidity of interests.
- Child patient with ASD diagnosis confirmed in the patient's files according to "the DSM-V criteria" (American Psychiatric Association, 2013).
- Child patient with mild to moderate ASD according to "the Childhood Autism Rating Scale (CARS)" (Schopler et al., 1998).
Key exclusion criteria (4 listed)
- Patient age younger than 6 years and older than 10 years.
- Child patient with other congenital anomalies, for example, "Cerebral Palsy" or "Down Syndrome".
- Child patient with previous dental experience.
- Child patient with severe ASD according to "the Childhood Autism Rating Scale (CARS)" (Schopler et al., 1998).
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 |
|---|---|---|
| Modified dental visual aidsModified Dental visual aids in the form of pictures created by the main investigator | Other | Modified dental visual aids |
| Regular dental visual aidsRegular dental visual aids | Other | Regular dental visual aids |
Primary outcome
Plaque Index Scoring
Time frame: four weeks
plaque index scoring (Silness and Löe, 1964)
Anxiety Scale for Children with Autism Spectrum Disorder (ASC-ASD)
Time frame: four weeks
This scale contains twenty-four "self-report" questions that inquire about anxiety, it contains 4 sub-scales including: 1. Separation Anxiety (SA). 2. Uncertainty (U). 3. Performance Anxiety (PA). 4. Anxious Arousal (AA). It is a four-point "Likert-scale"; items in the questionnaire are rated from zero ("never") to three ("always"). Another version of the same scale with twenty-four questions directed to the parents will also be used and it contains a report of their child's symptoms of anxiety, within the same four subscales (Rodgers et al., 2016).
The Observational Scale of Behavioral Distress (OSBD)
Time frame: four weeks
This scale is used to measure the behavioral distress that a child experiences when undergoing a painful procedure. This scale is composed of eight operationally defined behaviors that are indicative of anxiety and/or pain behavior in children. The OSBD is a valid and reliable scale that measures distress in children receiving painful procedures in the medical and dental practice, for example, venipuncture and needle injections (Elliot et al., 1987).
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 17 Aug 2022.
- Individual participant dataSharing planned: No
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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 Modified dental visual aids and Regular dental visual aids in people with Child Autism, run by King Abdulaziz University at 1 site in Saudi Arabia.
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 4 inclusion and 4 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 17 Aug 2022. 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 Saudi Arabia. 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?
Plaque Index Scoring (time frame: four weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Aug 2022.