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Clinical Trials/NCT04576559
NCT04576559
Completed
Not Applicable

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

King Abdulaziz University1 site in 1 country64 target enrollmentSeptember 1, 2019
ConditionsChild Autism

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Child Autism
Sponsor
King Abdulaziz University
Enrollment
64
Locations
1
Primary Endpoint
Plaque Index Scoring
Status
Completed
Last Updated
3 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
September 1, 2019
End Date
August 30, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ala Aljubour

Principal Investigator

King Abdulaziz University

Eligibility Criteria

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).

Outcomes

Primary Outcomes

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).

Study Sites (1)

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