Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-26 @ 3:14 AM
Study NCT ID:
NCT06443320
Status:
RECRUITING
Last Update Posted:
2025-02-06
First Post:
2024-05-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Videodrama Therapeutic Device for Children With Autism Spectrum Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D001321', 'term': 'Autistic Disorder'}], 'ancestors': [{'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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-03-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-04', 'studyFirstSubmitDate': '2024-05-30', 'studyFirstSubmitQcDate': '2024-05-30', 'lastUpdatePostDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dunn Sensory Profile questionnaire', 'timeFrame': '9 months', 'description': 'Sensory atypicality frequency will be assessed using the Dunn Sensory Profile questionnaire, describing child behavior in various sensory experiences'}], 'secondaryOutcomes': [{'measure': 'Cars-T questionnaire', 'timeFrame': '9 months', 'description': 'Observe improvements in social skills (interaction and communication) in children with ASD, assessed by the Cars-T questionnaire,'}, {'measure': 'Sceno Test', 'timeFrame': '9 months', 'description': 'Observation of the emergence of a symbolic game. This emergence will be evaluated by the passation of the scenotest, a test which reveals the different modalities of integration of the game.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['autism', 'videodrama'], 'conditions': ['Autism Spectrum Disorder (ASD)']}, 'descriptionModule': {'briefSummary': 'Autism spectrum disorder (ASD) is a neurodevelopmental disorder (Valerie, Sperenza, 2009) that begins early in development, characterized by persistent deficits in communication and social interactions across various contexts and restricted, repetitive patterns of behavior, interests, or activities. These symptoms significantly impact social, school/professional functioning, or other important areas and are not better explained by intellectual disability or global developmental delay (American Psychiatric Association, 2013).', 'detailedDescription': 'Currently, managing children with ASD emphasizes compensating for communication and social interaction disabilities. Communication tools like PECS or Makaton and social skills groups have shown effectiveness but have limitations, particularly not addressing sensory atypicalities seen in children with ASD. These sensory atypicalities are evident when children watch videos on screens. The idea is to use video to understand the sensory experiences of children with ASD and help them move away from an isolated relationship with screens. New technologies can further isolate children with ASD in their autistic sphere. The hypothesis is that observing these children with screens will provide better understanding of their sensory experiences and improve therapeutic support towards play and interaction with others'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged 3 to 15 years.\n* Clinically confirmed ASD by a psychiatrist.\n* Parental or legal guardian consent for participation.\n* Child showing a strong interest in screens and/or video content.\n* Ability to tolerate the presence of other children.\n* Minimum of 18 video drama sessions.\n* Not having benefited from disease care in the past.\n* Affiliation to a social security system\n\nExclusion Criteria:\n\n* No ASD diagnosis.\n* Younger than 3 or older than 15 at the study start.\n* No interest in screens or video content.\n* Parental or legal guardian refusal for participation.\n* Dropping out before completing 18 sessions.\n* Patient having benefited a disease care in the past'}, 'identificationModule': {'nctId': 'NCT06443320', 'acronym': 'VIDEOTSA', 'briefTitle': 'Evaluation of the Videodrama Therapeutic Device for Children With Autism Spectrum Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Intercommunal Robert Ballanger'}, 'officialTitle': 'Evaluation of the Videodrama Therapeutic Device for Children With Autism Spectrum Disorders', 'orgStudyIdInfo': {'id': 'GHT_CHIRB 20220420'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group of young ASD patients receiving videodrama sessions and interviews', 'description': 'Children participating in videodrama sessions, one per week for 9 sessions.', 'interventionNames': ['Other: patient included in experimental groupe will view the video excerpt, a playtime, a drawing activities']}, {'type': 'NO_INTERVENTION', 'label': 'Cohort of ASD patients not receiving videodrama but receiving care in participating units', 'description': 'Patients included in the cohort will be managed as part of their routine care'}], 'interventions': [{'name': 'patient included in experimental groupe will view the video excerpt, a playtime, a drawing activities', 'type': 'OTHER', 'description': 'Patients included in the videodrama arm will participate in a total of 18 videodrama sessions, with one session per week. Each session will include a patient welcome period, the viewing of a video excerpt (in slow motion or not), a playtime, a drawing period, and a group closing session. For the play and drawing activities, the same materials will be provided in each department and for each group, including small figurines, animals, shapes (such as cubes, triangles, circles), small plush toys, markers, colored pencils, and A4 white sheets of paper.', 'armGroupLabels': ['Group of young ASD patients receiving videodrama sessions and interviews']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93600', 'city': 'Aulnay-sous-Bois', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Mathilde ZERR', 'role': 'CONTACT', 'email': 'mathilde.zerr@ght-gpne.fr', 'phone': '0182372332'}, {'name': 'Constance LEMARCHAND', 'role': 'CONTACT', 'email': 'constance.lemarchand@ght-gpne.fr', 'phone': '01 49 36 72 50'}, {'name': 'Virginie CRUVEILLER', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHI Robert Ballanger', 'geoPoint': {'lat': 48.93814, 'lon': 2.49402}}], 'centralContacts': [{'name': 'Constance LEMARCHAND', 'role': 'CONTACT', 'email': 'constance.lemarchand@ght-gpne.fr', 'phone': '0182372332'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Intercommunal Robert Ballanger', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}