Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 11:21 PM
Study NCT ID:
NCT06253793
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-14
First Post:
2024-02-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tool for Evaluating the Effectiveness of the DENVER Protocol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D003142', 'term': 'Communication'}, {'id': 'D007802', 'term': 'Language'}, {'id': 'D019066', 'term': 'Facies'}], 'ancestors': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-05-13', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2028-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-13', 'studyFirstSubmitDate': '2024-02-02', 'studyFirstSubmitQcDate': '2024-02-02', 'lastUpdatePostDateStruct': {'date': '2024-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'looking time during natural social scenes', 'timeFrame': 'measure of 10 minutes :once for the ASD control and TD control groups. Repeated 4 times (every 3 months) for the ASD Experimental group', 'description': "Looking time in natural interaction situations is measured by recording the direction and time of the child's gaze at faces and objects in real social scenes using a video camera. The recording is then viewed by experimenters and manually coded frame by frame (sampling frequency 25 frames/second), determining which areas of interest (face, object) are looked at by the child at each time step. This measurement is less precise than the following one, but enables us to assess these children's social skills in real scenes of adult/child interaction (PART 1 of the data collection)."}, {'measure': 'looking time to social scenes presented on a screen', 'timeFrame': 'measure of 10 minutes :once for the ASD control and TD control groups. Repeated 4 times (every 3 months) for the ASD Experimental group', 'description': "Looking time during the viewing of social scenes presented on a screen is measured using an eye-tracking system, suitable for studying populations as young as 3 months. The eye-tracker is a device used to measure very precisely (x and y spatial coordinates at a temporal sampling frequency of around 30 Hertz) where the child's gaze rests and for how long in a 2D social scene presented on screen (PART 2 of data collection). These data are collected automatically by the eye tracker (spatial coordinates at each time step) and then coded into areas of interest (gaze locations: eyes, mouth...)."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Communication', 'Language', 'Attention', 'Face', 'Children'], 'conditions': ['Autism Spectrum Disorder']}, 'descriptionModule': {'briefSummary': 'Early remediation of the communicative and social difficulties of children with autism spectrum disorders (ASD) is central. However, from the age of 6-8 months, children with ASD show a lack of attention to social stimuli such as faces: such early avoidance behavior could be at the root of later communicative difficulties (language, attention). The Denver program aims to stimulate social communication and attention to faces in children with ASD aged between 18 and 60 months. Although the Denver protocol is currently recommended by the French National Authority for Health (HAS), the Denver protocol has not yet been widely used or evaluated in France, mainly due to a lack of tools adapted to non-verbal populations. The goal of FaceCom is to help clinicians to evaluate the efficiency of the Denver Protocol.', 'detailedDescription': 'Early remediation of the communicative and social difficulties of children with autism spectrum disorders (ASD) is central. However, from the age of 6-8 months, children with ASD show a lack of attention to social stimuli such as faces: such early avoidance behavior could be at the root of later communicative difficulties (language, attention). The Denver program aims to stimulate social communication and attention to faces in children with ASD aged between 18 and 60 months. Although the Denver protocol is currently recommended by the French National Authority for Health (HAS), the Denver protocol has not yet been widely used or evaluated in France, mainly due to a lack of tools adapted to non-verbal populations. The goal of FaceCom is to help clinicians to evaluate the efficiency of the Denver Protocol.\n\nFor children with ASD benefiting from the Denver protocol, the investigators hypothesize that an improvement in attention to social stimuli (faces, language) should be observed thanks to the Denver protocol intervention. Before the protocol, language and attention to faces of children with ASD included in the Denver protocol should resemble that of children with ASD of the same age who had not benefited from the Denver program. At the end of the Denver protocol, performance from children with ASD included in the Denver protocol should tend towards that of typically developing children of the same developmental age.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '18 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'ASD Experimental Group Children with Autism Spectrum Disorder (ASD) enrolled in the DENVER protocol. Same chronological age (1.5 years to 5 years of age) than children with ASD NOT enrolled in the DENVER protocol.\n\nASD Control Group Children with Autism Spectrum Disorder (ASD) NOT enrolled in the DENVER protocol.\n\nTD Control Group Typically developing (TD) children with the same developmental age than children with ASD', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria for all groups\n\n* native language: French\n* oral consent of the child, if able to do so, written consent of 2 parents or legal guardians\n\nInclusion criteria for the ASD experimental and control groups:\n\n-ASD Diagnosis The diagnosis of ASD is clinical and is made by the referring physician. It is based on the DSM 5 and the clinical assessment of each patient.\n\nInclusion criteria for the ASD experimental group:\n\n* absence of neurological pathology (epilepsy, etc.) and known genetic syndrome on admission\n* written consent of 2 parents or legal guardians\n\nNon-inclusion criteria for all children:\n\n\\- primary hearing and visual impairment (unless fully corrected).\n\nNon-inclusion criteria for DT children only:\n\n\\- a known neurodevelopmental, neurological or psychiatric disorder.'}, 'identificationModule': {'nctId': 'NCT06253793', 'acronym': 'FACECOM', 'briefTitle': 'Tool for Evaluating the Effectiveness of the DENVER Protocol', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Tool for Evaluating the Effectiveness of the DENVER Protocol for Attention to Faces (Face) and the Development of Social Communication (Com) in Young Children With Autism Spectrum Disorder (ASD)', 'orgStudyIdInfo': {'id': '38RC23.0401'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ASD Experimental group', 'description': 'Children with Autism Spectrum Disorder (ASD) enrolled in the DENVER protocol. Same chronological age (1.5 years to 5 years of age) than children with ASD NOT enrolled in the DENVER protocol. Those children will be recruited and tested at the Alps-Isere Hospital Center (Saint-Egreve, France)'}, {'label': 'ASD Control group', 'description': 'Children with Autism Spectrum Disorder (ASD) en NOT enrolled in the DENVER protocol. Same chronological age (1.5 years to 5 years of age) than children with ASD enrolled in the DENVER protocol. Those children will be recruited and tested at the Savoie Hospital Center (Chambery, France) and at the Grenoble University Hospital (Grenoble, France).'}, {'label': 'TD control group', 'description': 'Typically developing (TD) children with the same developmental age than children with ASD. Those children will be recruited and tested at the University Grenoble Alps (Grenoble, France).'}]}, 'contactsLocationsModule': {'locations': [{'zip': '38120', 'city': 'Saint-Égrève', 'state': 'Isere', 'country': 'France', 'contacts': [{'name': 'Isabelle Palacios, MD', 'role': 'CONTACT', 'email': 'ipalacios@ch-alpes-isere.fr'}], 'facility': 'Alps-Isere Hospital Center', 'geoPoint': {'lat': 45.23313, 'lon': 5.68154}}, {'zip': '73000', 'city': 'Chambéry', 'state': 'Savoie', 'country': 'France', 'contacts': [{'name': 'Marine Goubier, MD', 'role': 'CONTACT', 'email': 'M.GOUBIER@chs-savoie.fr'}], 'facility': 'Savoie Hospital Center', 'geoPoint': {'lat': 45.56628, 'lon': 5.92079}}, {'zip': '38058', 'city': 'Grenoble', 'country': 'France', 'contacts': [{'name': 'Mathilde FORT, PhD', 'role': 'CONTACT', 'email': 'mathilde.fort@univ-grenoble-alpes.fr'}], 'facility': 'University Grenoble Alps', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}], 'centralContacts': [{'name': 'Stéphanie BIOULAC-ROGIER, Pr, MD', 'role': 'CONTACT', 'email': 'sbioulacrogier@chu-grenoble.fr'}, {'name': 'Mathilde Fort, PhD', 'role': 'CONTACT', 'email': 'mathilde.fort@univ-grenoble-alpes.fr', 'phone': '0033688044214'}], 'overallOfficials': [{'name': 'Mathilde FORT, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Grenoble Alps'}, {'name': 'Isabelle Palacios, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Alps-Isere Hospital Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Grenoble Alps', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}