Autism With High Cognitive AbilitiesNCT05197634
The Impact of Covid-19 Pandemic On The Children With Autism Spectrum Disorder
An observational study of Autism With High Cognitive Abilities and COVID-19 Pandemic, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
The Covid-19 outbreak has caused families and individuals to change their life routines and eating habits, and has affected their psychology, especially for children with autism, due to the change in their routines. Read more about this study
- Who is it for?
- Ages 3 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism With High Cognitive Abilities, COVID-19 Pandemic
- What is being tested?
- Not Applicable (observation)
- How many people
- 330 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Sep 2021to 5 Aug 2022
- Phase
- Observational
- 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 3 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: A total of 200 patients per month in the 3-14 age group who are being followed up with a diagnosis of autism from the Department of Child Psychiatry of Istanbul University, and 165 children will be selected by simple random sampling method from among the patients who applied to the clinic during the study period. On the other hand, healthy controls who applied to Istanbul University Faculty of Dentistry, Department of Pedodontics between September 6, 2021 and March 31, 2022 and met the inclusion criteria will be included in the order of application to the outpatient clinic.
Who may be able to join
- Volunteering to participate in the study
- Children between the ages of 3-14 who have been diagnosed with autism
- Healthy children aged 3-14 years
- Presence of parents who can adequately answer the questionnaire questions
Who cannot join
- Not willing to participate in the study
- Patients with an unclear diagnosis of autism
- Those younger than 3 years old and over 14 years old
- In case of not being able to answer the questionnaire questions from the parents or remembering the trauma history
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University, Faculty of Dentistry
Istanbul
About this study
Official title: The Impact of Covid-19 Pandemic, On The Eating Habits, Lifestyle Changes and Traumatic Injuries In The Children With Autism Spectrum Disorder
The Covid-19 outbreak has caused families and individuals to change their life routines and eating habits, and has affected their psychology, especially for children with autism, due to the change in their routines. These psychological changes may trigger the self-harming behavior that is very common in children with autism.
Dental trauma, a common problem in children and adolescents, can also be seen in individuals who need special care such as autism.
The aim of this study is to evaluate the susceptibility of children with autism to orofacial trauma during the pandemic period and compare them with the pre-pandemic period and the healthy group, as well as to question the lifestyle, nutritional habits, mood changes and oral health behaviors that may be related to the risk of trauma.
Read the detailed description
The study is being carried out in Istanbul University Department of Pediatric Dentistry, period between September 2021 - March 2022 following the ethics committee approval 2021/49. Patient parents are informed about the study following the initial dental examination of the patient and the written informed consents are obtained from parents of all participants included in the study.
The orofacial trauma history, dietary habits and lifestyle changes of children aged 3-14 years diagnosed with autism in Istanbul University Department of Child Psychiatry and healthy children applying to Istanbul University Faculty of Dentistry Department of Pediatric Dentistry will be evaluated through a questionnaire to be applied to their families.
Questionnaire;
- 13 questions to question the sociodemographic profile,
- 10 questions to question the child's systemic disease history, oral hygiene habits and oral health status,
- 12 questions to question eating habits,
- 6 questions to question the child's lifestyle and psychological changes due to the Covid-19 pandemic,
- 20 questions to question the trauma story,
- In order to measure the DMFT/dmft status, 1 index will be filled and applied. Intraoral examinations of the children with autism who accepted to participate in the study, who came to the Istanbul University Child Psychiatry Department for examination, will also be examined, if there is any sign or history of trauma, it will be recorded and the possible causes of the trauma, its type, time, place and accompanying clinical findings will be evaluated and risk factors that may cause trauma (overjet/overbite) will be recorded.
- While evaluating dental traumas, hard tissue and periodontal tissue injuries will be recorded separately.
- Since X-rays cannot be taken from these patients, traumas related to the root in hard tissue injuries will not be evaluated.
- The amount of overjet and overbite; will be examined using an intraoral mirror and a periodontal probe. The amount of overjet will be recorded by measuring the distance of the upper incisors to the lower incisors when the jaws are in normal closing. When measuring the amount of overbite, the amount of covering the cutting edges of the lower incisors by the cutting edges of the upper incisors will be determined when the jaws are in normal closing.
- In addition, the patients with autism who came to the Department of Child Psychiatry of Istanbul University for examination and who accepted to participate in the study, will be measured with the help of the DMFT/dmft index, whether they have a history of trauma or not, while performing intraoral examinations.
A control group will be formed from healthy children who applied to the Pediatric Dentistry Department of Istanbul University without autism, taking into account the gender and age distribution of children with autism. Then, the groups will be compared within themselves and with each other, taking into account the pandemic period and before.
- Being tested
- Not Applicable (observation)
- Keywords
- ASD (autism spectrum disorder), Covid-19, Dental trauma, Eating habits, Lifestyle changes
- Medical subject headings
- COVID-19, Autism Spectrum Disorder, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not Applicable (observation)Other
Questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Children with Autism Spectrum Disorder | The orofacial trauma history, dietary habits and lifestyle changes of children aged 3-14 years diagnosed with autism in Istanbul University Department of Child Psychiatry evaluated through a questionnaire to be applied to their families. Receives: Other: Not Applicable (observation) | |
| Healthy children | The orofacial trauma history, dietary habits and lifestyle changes of healthy children aged 3-14 years applying to Istanbul University Faculty of Dentistry Department of Pediatric Dentistry will be evaluated through a questionnaire to be applied to their families. Receives: Other: Not Applicable (observation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the effect of the COVID-19 pandemic
The orofacial trauma history, dietary habits and lifestyle changes of children aged 3-14 years diagnosed with autism in Istanbul University Department of Child Psychiatry and healthy children applying to Istanbul University Faculty of Dentistry Department of Pediatric Dentistry will be evaluated through a questionnaire to be applied to their families.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start6 Sep 2021
- Primary completion9 May 2022
- Study completion5 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism With High Cognitive AbilitiesStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul Kent University
- Responsible party
- Principal investigator, Yelda Kasımoğlu, Istanbul University
- Investigators
- Arzu Pinar Erdem, Prof., Study director, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05197634
- Sponsor's protocol ID
- 2021/49
- Status last verified
- Mar 2024
- First submitted
- 5 Jan 2022
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- 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 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Covid-19 Pandemic, On The Eating Habits, Lifestyle Changes and Traumatic Injuries In The Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT05197634
- Acronym / sponsor ID
- 2021/49
- Keywords
- ASD (autism spectrum disorder), Covid-19, Dental trauma, Eating habits, Lifestyle changes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Collaborators
- Istanbul Kent University
- Study start
- 6 Sep 2021 (actual)
- Primary completion
- 9 May 2022 (actual)
- Study completion
- 5 Aug 2022 (actual)
- First posted
- 19 Jan 2022 (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 Covid-19 outbreak has caused families and individuals to change their life routines and eating habits, and has affected their psychology, especially for children with autism, due to the change in their routines. These psychological changes may trigger the self-harming behavior that is very common in children with autism.
Dental trauma, a common problem in children and adolescents, can also be seen in individuals who need special care such as autism.
The aim of this study is to evaluate the susceptibility of children with autism to orofacial trauma during the pandemic period and compare them with the pre-pandemic period and the healthy group, as well as to question the lifestyle, nutritional habits, mood changes and oral health behaviors that may be related to the risk of trauma.
Detailed description
The study is being carried out in Istanbul University Department of Pediatric Dentistry, period between September 2021 - March 2022 following the ethics committee approval 2021/49. Patient parents are informed about the study following the initial dental examination of the patient and the written informed consents are obtained from parents of all participants included in the study.
The orofacial trauma history, dietary habits and lifestyle changes of children aged 3-14 years diagnosed with autism in Istanbul University Department of Child Psychiatry and healthy children applying to Istanbul University Faculty of Dentistry Department of Pediatric Dentistry will be evaluated through a questionnaire to be applied to their families.
Questionnaire;
- 13 questions to question the sociodemographic profile,
- 10 questions to question the child's systemic disease history, oral hygiene habits and oral health status,
- 12 questions to question eating habits,
- 6 questions to question the child's lifestyle and psychological changes due to the Covid-19 pandemic,
- 20 questions to question the trauma story,
- In order to measure the DMFT/dmft status, 1 index will be filled and applied. Intraoral examinations of the children with autism who accepted to participate in the study, who came to the Istanbul University Child Psychiatry Department for examination, will also be examined, if there is any sign or history of trauma, it will be recorded and the possible causes of the trauma, its type, time, place and accompanying clinical findings will be evaluated and risk factors that may cause trauma (overjet/overbite) will be recorded.
- While evaluating dental traumas, hard tissue and periodontal tissue injuries will be recorded separately.
- Since X-rays cannot be taken from these patients, traumas related to the root in hard tissue injuries will not be evaluated.
- The amount of overjet and overbite; will be examined using an intraoral mirror and a periodontal probe. The amount of overjet will be recorded by measuring the distance of the upper incisors to the lower incisors when the jaws are in normal closing. When measuring the amount of overbite, the amount of covering the cutting edges of the lower incisors by the cutting edges of the upper incisors will be determined when the jaws are in normal closing.
- In addition, the patients with autism who came to the Department of Child Psychiatry of Istanbul University for examination and who accepted to participate in the study, will be measured with the help of the DMFT/dmft index, whether they have a history of trauma or not, while performing intraoral examinations.
A control group will be formed from healthy children who applied to the Pediatric Dentistry Department of Istanbul University without autism, taking into account the gender and age distribution of children with autism. Then, the groups will be compared within themselves and with each other, taking into account the pandemic period and before.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with Autism Spectrum Disorder | – | Other: Not Applicable (observation)The orofacial trauma history, dietary habits and lifestyle changes of children aged 3-14 years diagnosed with autism in Istanbul University Department of Child Psychiatry evaluated through a questionnaire to be applied to their families. |
| Healthy children | – | Other: Not Applicable (observation)The orofacial trauma history, dietary habits and lifestyle changes of healthy children aged 3-14 years applying to Istanbul University Faculty of Dentistry Department of Pediatric Dentistry will be evaluated through a questionnaire to be applied to their families. |
Who may qualify
- Ages
- 3 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- A total of 200 patients per month in the 3-14 age group who are being followed up with a diagnosis of autism from the Department of Child Psychiatry of Istanbul University, and 165 children will be selected by simple random sampling method from among the patients who applied to the clinic during the study period. On the other hand, healthy controls who applied to Istanbul University Faculty of Dentistry, Department of Pedodontics between September 6, 2021 and March 31, 2022 and met the inclusion criteria will be included in the order of application to the outpatient clinic.
Key inclusion criteria (4 listed)
- Volunteering to participate in the study
- Children between the ages of 3-14 who have been diagnosed with autism
- Healthy children aged 3-14 years
- Presence of parents who can adequately answer the questionnaire questions
Key exclusion criteria (4 listed)
- Not willing to participate in the study
- Patients with an unclear diagnosis of autism
- Those younger than 3 years old and over 14 years old
- In case of not being able to answer the questionnaire questions from the parents or remembering the trauma history
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 |
|---|---|---|
| Not Applicable (observation)Questionnaire | Other | Children with Autism Spectrum Disorder, Healthy children |
Primary outcome
Evaluation of the effect of the COVID-19 pandemic
Time frame: 1 year
The orofacial trauma history, dietary habits and lifestyle changes of children aged 3-14 years diagnosed with autism in Istanbul University Department of Child Psychiatry and healthy children applying to Istanbul University Faculty of Dentistry Department of Pediatric Dentistry will be evaluated through a questionnaire to be applied to their families.
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 6 Mar 2024.
- Individual participant dataSharing planned: No
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.
Arzu Pinar Erdem, Prof. study director
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism With High Cognitive Abilities and COVID-19 Pandemic, run by Istanbul University at 1 site in Turkey (Türkiye).
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 6 Mar 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 Turkey (Türkiye). 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?
Evaluation of the effect of the COVID-19 pandemic (time frame: 1 year). 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 6 Mar 2024.