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

Primary Purpose

Child Autism

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Modified dental visual aids
Regular dental visual aids
Sponsored by
King Abdulaziz University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Child Autism

Eligibility Criteria

6 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • King Abdulaziz University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Modified dental visual aids

Regular dental visual aids

Arm Description

Outcomes

Primary Outcome Measures

Plaque Index Scoring
plaque index scoring (Silness and Löe, 1964)
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).
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).

Secondary Outcome Measures

Full Information

First Posted
September 30, 2020
Last Updated
August 16, 2022
Sponsor
King Abdulaziz University
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1. Study Identification

Unique Protocol Identification Number
NCT04576559
Brief Title
Effect of Modified Dental Visual Aids on Behavior Management During Dental Treatment in Children With Autism Spectrum Disorder
Official Title
Effect of Modified Dental Visual Aids on Behavior Management During Dental Treatment in Children With Autism Spectrum Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
August 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Abdulaziz University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child Autism

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Modified dental visual aids
Arm Type
Experimental
Arm Title
Regular dental visual aids
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Modified dental visual aids
Intervention Description
Modified Dental visual aids in the form of pictures created by the main investigator
Intervention Type
Other
Intervention Name(s)
Regular dental visual aids
Intervention Description
Regular dental visual aids
Primary Outcome Measure Information:
Title
Plaque Index Scoring
Description
plaque index scoring (Silness and Löe, 1964)
Time Frame
four weeks
Title
Anxiety Scale for Children with Autism Spectrum Disorder (ASC-ASD)
Description
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).
Time Frame
four weeks
Title
The Observational Scale of Behavioral Distress (OSBD)
Description
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).
Time Frame
four weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
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).
Facility Information:
Facility Name
King Abdulaziz University
City
Jeddah
State/Province
Select A State Or Province
ZIP/Postal Code
21589
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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