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

NCT04576559 | Completed

• 1 other identifier: KingAbdulazizUni
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Child Autism

Outcome Measures

Primary Outcomes (3)

• Plaque Index Scoring

  plaque index scoring (Silness and Löe, 1964)

  four weeks

• 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: 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).

  four weeks

• 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

Study Arms (2)

Modified dental visual aids

EXPERIMENTAL

Other: Modified dental visual aids

Regular dental visual aids

ACTIVE COMPARATOR

Other: Regular dental visual aids

Interventions

Modified dental visual aids OTHER

Modified Dental visual aids in the form of pictures created by the main investigator

Modified dental visual aids

Regular dental visual aids OTHER

Regular dental visual aids

Regular dental visual aids

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• King Abdulaziz University: lead

Study Sites (1)

King Abdulaziz University

Jeddah, Select A State Or Province, 21589, Saudi Arabia

Location

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 30, 2020
• First Posted: October 6, 2020
• Study Start: September 1, 2019
• Primary Completion: July 1, 2021
• Study Completion: August 30, 2021
• Last Updated: August 17, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)