Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2026-01-01 @ 10:52 AM
Study NCT ID:
NCT06046768
Status:
UNKNOWN
Last Update Posted:
2023-09-21
First Post:
2023-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment and Remediation of Oral Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009059', 'term': 'Mouth Diseases'}], 'ancestors': [{'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'To evaluate the impact of psychological treatment on the improvement of oral disorders perceived by parents in their child.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2025-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-19', 'studyFirstSubmitDate': '2023-09-12', 'studyFirstSubmitQcDate': '2023-09-19', 'lastUpdatePostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Parental stress and child representation', 'timeFrame': '12 months', 'description': "Montreal children's Hospital scale. Parental stress and child representation will be assessed by three times t1 (before psychological management), t2 (after 5 months of psychological management) and t3 (after one year of discussion group)."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['parental stress', 'ENT pathology'], 'conditions': ['Oral Disorder']}, 'descriptionModule': {'briefSummary': 'As part of the Reference Center for Rare Diseases of the Robert Debré Hospital, many children have eating and verbal oral disorders. In this doctoral research, we question the psychological impact of oral disorders on the dynamics of family functioning.Our research entitled: Evaluation and Remediation of Orality Disorders (ERTO) aims to evaluate the impact of psychological care of the child and a support program for parents.\n\nWe hypothesized that this comprehensive management could contribute to improving disorders and consequently modify parental representations of the child and his disorders.\n\nIn addition, care focused on intra-family relations and communication would allow a decentralization and a repositioning of the problem of disorders within the family dynamic.\n\nThe results of this research will have concrete applications for the management of children suffering from oral disorders.', 'detailedDescription': 'The ERTO search follows the first PREORA search. As soon as the results of the PREORA questionnaires are obtained, we would constitute a cohort of 16 children - a maximum of 32 parents and siblings. It will be extracted from participants in the PREORA study by random draw after screening eligibility according to the inclusion criteria and their desire to participate in this study.\n\nWe will study a population of children aged 18 months to 3 years, with ENT pathology, requiring surgery and invasive care.\n\nThe research consists of three stages:\n\nT0: An inclusion interview: standardized psychological interview (recorded Stern R interview and PSI Parental Stress Scale). ""R interview"" is a questionnaire published and validated in 1989 by Stern, Robert-Tissot, Besson, et al.\n\nIt allows the evaluation of maternal representations. The Parental Stress Index (PSI), translated in Quebec by Bigras and Lafrenière, is used to detect difficulties in parent-child dyads.\n\nT1-T5: Then a follow-up will be proposed (five psychological consultations (interviews, scales), participation in a discussion group for parents in Visio via Zoom, a speech therapy assessment and possible complementary multidisciplinary consultations) T6: Again an assessment with the T0 retest (Stern R Interview, PSI Parental Stress Scale, MCH scale). This study is a non-randomized exploratory research with two controlled groups, before/after.\n\nParental stress and child representation will be assessed according to the two subgroups of belonging, group A (antenatal diagnosis), group B (postnatal diagnosis), t1 (before psychological management), t2 (after 5 months of psychological management) and t3 (after one year of discussion group). Qualitative and quantitative analyses will be provided, based on variables.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Years', 'minimumAge': '18 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Child (boy or girl) with oral feeding disorder(s) diagnosed by a speech therapist as part of a speech therapy assessment\n* Patients under ENT care at Robert Debré Hospital\n* Children aged 18 months to 3 years\n* French-speaking parents\n* Living at home in France\n* Affiliation with a social security scheme or entitled beneficiary\n* Informed consent signed by both parents\n\nExclusion Criteria:\n\n* Pathologies predominantly associated with ENT pathology\n* Neurological disorders\n* Deafness'}, 'identificationModule': {'nctId': 'NCT06046768', 'acronym': 'ERTO', 'briefTitle': 'Assessment and Remediation of Oral Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'The Consequences of Child Verbal and Eating Disorders on Family Dynamics in the Context of Ear Nose and Throat (ENT) Pathologies - Integration of Non-verbal Communication and Parental Support', 'orgStudyIdInfo': {'id': 'APHP230152'}, 'secondaryIdInfos': [{'id': 'IDRCB: 2023-A00202-43', 'type': 'REGISTRY', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Child with oral feeding disorder(s)', 'description': 'Child (boy or girl) with oral feeding disorder(s) diagnosed by a speech therapist as part of a speech therapy assessment.', 'interventionNames': ['Other: Psychological care']}], 'interventions': [{'name': 'Psychological care', 'type': 'OTHER', 'description': 'Psychological consultations (interviews, scales), participation in a discussion group for parents in Visio via Zoom, a speech therapy assessment and possible complementary multidisciplinary consultations)', 'armGroupLabels': ['Child with oral feeding disorder(s)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75019', 'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Natacha TEISSIER, MD PhD', 'role': 'CONTACT', 'email': 'natacha.teissier@aphp.fr', 'phone': '+33.1.40.03.53.67'}, {'name': 'Elise CHAUVIN, Doctorant', 'role': 'CONTACT', 'email': 'elise.chauvin@aphp.fr', 'phone': '+33.1.86.46.82.21'}], 'facility': 'Robert Debre Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Natacha TEISSIER, MD PhD', 'role': 'CONTACT', 'email': 'natacha.teissier@aphp.fr', 'phone': '+33.1.40.03.53.67'}, {'name': 'Elise CHAUVIN, Doctorant', 'role': 'CONTACT', 'email': 'elise.chauvin@aphp.fr', 'phone': '+331.86.46.82.21.67'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}