NCT05197634

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
330

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 6, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 19, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 9, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2022

Completed
Last Updated

March 6, 2024

Status Verified

March 1, 2024

Enrollment Period

8 months

First QC Date

January 5, 2022

Last Update Submit

March 4, 2024

Conditions

Keywords

ASD (autism spectrum disorder)Covid-19Dental traumaEating habitsLifestyle changes

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 year

Study Arms (2)

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.

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.

Other: Not Applicable (observation)

Interventions

Questionnaire

Children with Autism Spectrum DisorderHealthy children

Eligibility Criteria

Age3 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University, Faculty of Dentistry

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19Autism Spectrum DisorderFeeding Behavior

Interventions

Observation

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesChild Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersBehavior, AnimalBehavior

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Arzu Pinar Erdem, Prof.

    Istanbul University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 5, 2022

First Posted

January 19, 2022

Study Start

September 6, 2021

Primary Completion

May 9, 2022

Study Completion

August 5, 2022

Last Updated

March 6, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations