Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-26 @ 5:57 PM
Study NCT ID:
NCT04576559
Status:
COMPLETED
Last Update Posted:
2022-08-17
First Post:
2020-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Modified Dental Visual Aids on Behavior Management During Dental Treatment in Children With Autism Spectrum Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001321', 'term': 'Autistic Disorder'}], 'ancestors': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-16', 'studyFirstSubmitDate': '2020-09-30', 'studyFirstSubmitQcDate': '2020-10-05', 'lastUpdatePostDateStruct': {'date': '2022-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plaque Index Scoring', 'timeFrame': 'four weeks', 'description': 'plaque index scoring (Silness and Löe, 1964)'}, {'measure': 'Anxiety Scale for Children with Autism Spectrum Disorder (ASC-ASD)', 'timeFrame': 'four weeks', 'description': 'This scale contains twenty-four "self-report" questions that inquire about anxiety, it contains 4 sub-scales including:\n\n1. Separation Anxiety (SA).\n2. Uncertainty (U).\n3. Performance Anxiety (PA).\n4. 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).'}, {'measure': 'The Observational Scale of Behavioral Distress (OSBD)', 'timeFrame': 'four weeks', '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).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Child Autism']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient age between 6-10 years.\n* Child patient has to represent the typical triad symptoms of ASD that include: social interaction deficits, communication impairment, language impairment and rigidity of interests.\n* Child patient with ASD diagnosis confirmed in the patient\'s files according to "the DSM-V criteria" (American Psychiatric Association, 2013).\n* Child patient with mild to moderate ASD according to "the Childhood Autism Rating Scale (CARS)" (Schopler et al., 1998).\n\nExclusion Criteria:\n\n* Patient age younger than 6 years and older than 10 years.\n* Child patient with other congenital anomalies, for example, "Cerebral Palsy" or "Down Syndrome".\n* Child patient with previous dental experience.\n* Child patient with severe ASD according to "the Childhood Autism Rating Scale (CARS)" (Schopler et al., 1998).'}, 'identificationModule': {'nctId': 'NCT04576559', 'briefTitle': 'Effect of Modified Dental Visual Aids on Behavior Management During Dental Treatment in Children With Autism Spectrum Disorder', 'organization': {'class': 'OTHER', 'fullName': 'King Abdulaziz University'}, 'officialTitle': 'Effect of Modified Dental Visual Aids on Behavior Management During Dental Treatment in Children With Autism Spectrum Disorder', 'orgStudyIdInfo': {'id': 'KingAbdulazizUni'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Modified dental visual aids', 'interventionNames': ['Other: Modified dental visual aids']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Regular dental visual aids', 'interventionNames': ['Other: Regular dental visual aids']}], 'interventions': [{'name': 'Modified dental visual aids', 'type': 'OTHER', 'description': 'Modified Dental visual aids in the form of pictures created by the main investigator', 'armGroupLabels': ['Modified dental visual aids']}, {'name': 'Regular dental visual aids', 'type': 'OTHER', 'description': 'Regular dental visual aids', 'armGroupLabels': ['Regular dental visual aids']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21589', 'city': 'Jeddah', 'state': 'Select A State Or Province', 'country': 'Saudi Arabia', 'facility': 'King Abdulaziz University', 'geoPoint': {'lat': 21.49012, 'lon': 39.18624}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Abdulaziz University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ala Aljubour', 'investigatorAffiliation': 'King Abdulaziz University'}}}}