Effect of Modified Dental Visual Aids on Behavior Management During Dental Treatment in Children With Autism Spectrum Disorder

Child Autism Clinical Trial

Official title:

Effect of Modified Dental Visual Aids on Behavior Management During Dental Treatment in Children With Autism Spectrum Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04576559
• Other study ID #: KingAbdulazizUni
• Status: Completed
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: August 30, 2021

Study information

• Verified date: August 2022
• Source: King Abdulaziz University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 during the dental appointment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: August 30, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 10 Years

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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).

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Autism

Intervention

Other:
• Modified dental visual aids
Modified Dental visual aids in the form of pictures created by the main investigator
• Regular dental visual aids
Regular dental visual aids

Locations

Country	Name	City	State
Saudi Arabia	King Abdulaziz University	Jeddah	Select A State Or Province

Sponsors (1)

Lead Sponsor	Collaborator
King Abdulaziz University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plaque Index Scoring	plaque index scoring (Silness and Löe, 1964)	four weeks
Primary	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).	four weeks
Primary	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).	four weeks