Ignite Creation Date:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2026-01-01 @ 7:13 PM
Study NCT ID:
NCT01331057
Status:
COMPLETED
Last Update Posted:
2021-06-15
First Post:
2011-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bilingualism: Validation Of "Avicenne's Elal"
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007802', 'term': 'Language'}], 'ancestors': [{'id': 'D003142', 'term': 'Communication'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007407', 'term': 'Interviews as Topic'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 125}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-14', 'studyFirstSubmitDate': '2011-04-05', 'studyFirstSubmitQcDate': '2011-04-06', 'lastUpdatePostDateStruct': {'date': '2021-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-04-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Validation of an instrument of the first language assessment.', 'timeFrame': 'at 54 months', 'description': 'Validation of "avicenne\'s ELAL": instrument of mother tongue assessment'}], 'secondaryOutcomes': [{'measure': 'Impact of familial and transcultural factors', 'timeFrame': 'at 54 months', 'description': "impact of familial and transcultural factors on early bilingualism in migrants' children born in france"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bilingualism', 'Language', 'Evaluation transcultural', 'Intra Familial Relationship', 'Transmissions mother', 'Tongue french', 'Language tamil', 'Language arabic', 'Language soninke', 'Language cultural', 'Affiliations crossbreeding'], 'conditions': ['Language']}, 'descriptionModule': {'briefSummary': 'The primary purpose is the validation of an instrument of the first language assessment. The second purpose is to study the impact of familial and transcultural factors on early bilingualism in migrant children born in France.', 'detailedDescription': "The research aims to validate a language instrument of the first language in migrants' children born in France. For that purpose, the investigators have built an instrument made of three sets of items: comprehension, production and narrative production. Children are elected if: they are four to six years old, in the third class of nursery school and if their first language is unique, and, one of the three languages that the investigators define for the first step of validation: tamil, SONINKE, Arabic. The PROTOCOLE is composed with two parts:\n\n1. For children:\n\n * An assessment for children in French with items extracted from the NEEL test\n * An assessment of mother tongue with the ELAL of Avicenne\n2. For parents:\n\n * A semi-structured interview.\n\nThe data collected are:\n\nGeneral DATA:\n\n* Social and professional categories\n* Economical status of parents\n* The conditions of living\n* Month and year of birth for the child\n* The language used during the interview\n\nAbout the child:\n\n* Age of language AQUISITION\n* Languages mastering\n* Language environment\n* The place among siblings\n* SCOLARISATION(DATA about cultural affiliations, representations of transmission, intra-familial relationship\n\nDATA about parental uses and representations of languages:\n\n* Social and economical DATA in the country of birth\n* Place of birth, languages\n* uses of languages\n* representations about languages"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children are five to six years old, in the third class of nursery school and if their first language is unique, and, one of the three languages that we defines for the first step of validation: tamil, soninké, Arabic', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age : four to six years old\n* SCOLARISATION : nursery school\n* One language in the family house: tamil, Arabic, or SONINKE\n\nExclusion Criteria:\n\n* first class of elementary school\n* two mother tongues in the family'}, 'identificationModule': {'nctId': 'NCT01331057', 'acronym': 'BILINGUISME', 'briefTitle': 'Bilingualism: Validation Of "Avicenne\'s Elal"', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Validation of "AVICENNE\'s ELAL": Instrument of Mother Tongue Assessment and Impact of Familial and Transcultural Factors on Early Bilingualism in Migrants\' Children Born in France', 'orgStudyIdInfo': {'id': 'NI07023'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1:Sri Lankais', 'description': 'Children aged of four to six years old, in the nursery school and if their first language is unique : tamil.', 'interventionNames': ['Other: NEEL test', 'Other: ELAL test', 'Other: Interview']}, {'label': '2: Algerian', 'description': 'Children aged of four to six years old, in the nursery school and if their first language is unique : arabic.', 'interventionNames': ['Other: NEEL test', 'Other: ELAL test', 'Other: Interview']}, {'label': '3: Mali', 'description': 'Children aged of four to six years old, in the nursery school and if their first language is unique : SONINKE.', 'interventionNames': ['Other: NEEL test', 'Other: ELAL test', 'Other: Interview']}], 'interventions': [{'name': 'NEEL test', 'type': 'OTHER', 'description': 'An assessment for children in French with items extracted from the NEEL test', 'armGroupLabels': ['1:Sri Lankais', '2: Algerian', '3: Mali']}, {'name': 'ELAL test', 'type': 'OTHER', 'description': 'An assessment of mother tongue with the ELAL of AVICENNE', 'armGroupLabels': ['1:Sri Lankais', '2: Algerian', '3: Mali']}, {'name': 'Interview', 'type': 'OTHER', 'description': 'For parents of children include in the study: A semi -structured interview', 'armGroupLabels': ['1:Sri Lankais', '2: Algerian', '3: Mali']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93000', 'city': 'Bobigny', 'state': 'Seine Saint-Denis', 'country': 'France', 'facility': 'Dr Dalila REZZOUG', 'geoPoint': {'lat': 48.90982, 'lon': 2.45012}}], 'overallOfficials': [{'name': 'Dalila REZZOUG, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}