LanguageBILINGUISMENCT01331057
Bilingualism: Validation Of "Avicenne's Elal"
An observational study of Language, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Language
- What is being tested?
- NEEL test, ELAL test and Interview
- How many people
- 125 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2011to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 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
Who may be able to join
- Age : four to six years old
- SCOLARISATION : nursery school
- One language in the family house: tamil, Arabic, or SONINKE
Who cannot join
- first class of elementary school
- two mother tongues in the family
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed description
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:
- For children:
- An assessment for children in French with items extracted from the NEEL test
- An assessment of mother tongue with the ELAL of Avicenne
- For parents:
- A semi-structured interview.
The data collected are:
General DATA:
- Social and professional categories
- Economical status of parents
- The conditions of living
- Month and year of birth for the child
- The language used during the interview
About the child:
- Age of language AQUISITION
- Languages mastering
- Language environment
- The place among siblings
- SCOLARISATION(DATA about cultural affiliations, representations of transmission, intra-familial relationship
DATA about parental uses and representations of languages:
- Social and economical DATA in the country of birth
- Place of birth, languages
- uses of languages
- representations about languages
- Conditions
- Language
- Being tested
- NEEL test, ELAL test, Interview
- Keywords
- Bilingualism, Language, Evaluation transcultural, Intra Familial Relationship, Transmissions mother, Tongue french, Language tamil, Language arabic, Language soninke, Language cultural, Affiliations crossbreeding
- Medical subject headings
- Language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEEL testOther
An assessment for children in French with items extracted from the NEEL test
ELAL testOther
An assessment of mother tongue with the ELAL of AVICENNE
InterviewOther
For parents of children include in the study: A semi -structured interview
| Study group | Role | What they receive |
|---|---|---|
| 1:Sri Lankais | Children aged of four to six years old, in the nursery school and if their first language is unique : tamil. Receives: Other: NEEL test; Other: ELAL test; Other: Interview | |
| 2: Algerian | Children aged of four to six years old, in the nursery school and if their first language is unique : arabic. Receives: Other: NEEL test; Other: ELAL test; Other: Interview | |
| 3: Mali | Children aged of four to six years old, in the nursery school and if their first language is unique : SONINKE. Receives: Other: NEEL test; Other: ELAL test; Other: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of an instrument of the first language assessment.
Validation of "avicenne's ELAL": instrument of mother tongue assessment
Measured: at 54 months
Secondary outcomes (1)
Impact of familial and transcultural factors
impact of familial and transcultural factors on early bilingualism in migrants' children born in france
Measured: at 54 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2011 (estimated)
- Study startJun 2011
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LanguageStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dalila REZZOUG, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01331057
- Sponsor's protocol ID
- NI07023
- Acronym
- BILINGUISME
- Status last verified
- Jun 2021
- First submitted
- 5 Apr 2011
- Last updated
- 15 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01331057
- Acronym / sponsor ID
- BILINGUISME / NI07023
- Conditions
- Language
- Keywords
- Bilingualism, Language, Evaluation transcultural, Intra Familial Relationship, Transmissions mother, Tongue french, Language tamil, Language arabic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jun 2011 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 7 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- For children:
- An assessment for children in French with items extracted from the NEEL test
- An assessment of mother tongue with the ELAL of Avicenne
- For parents:
- A semi-structured interview.
The data collected are:
General DATA:
- Social and professional categories
- Economical status of parents
- The conditions of living
- Month and year of birth for the child
- The language used during the interview
About the child:
- Age of language AQUISITION
- Languages mastering
- Language environment
- The place among siblings
- SCOLARISATION(DATA about cultural affiliations, representations of transmission, intra-familial relationship
DATA about parental uses and representations of languages:
- Social and economical DATA in the country of birth
- Place of birth, languages
- uses of languages
- representations about languages
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1:Sri Lankais | – | Other: NEEL test, Other: ELAL test, Other: InterviewChildren aged of four to six years old, in the nursery school and if their first language is unique : tamil. |
| 2: Algerian | – | Other: NEEL test, Other: ELAL test, Other: InterviewChildren aged of four to six years old, in the nursery school and if their first language is unique : arabic. |
| 3: Mali | – | Other: NEEL test, Other: ELAL test, Other: InterviewChildren aged of four to six years old, in the nursery school and if their first language is unique : SONINKE. |
Who may qualify
- Ages
- 5 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 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
Key inclusion criteria (3 listed)
- Age : four to six years old
- SCOLARISATION : nursery school
- One language in the family house: tamil, Arabic, or SONINKE
Key exclusion criteria (2 listed)
- first class of elementary school
- two mother tongues in the family
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NEEL testAn assessment for children in French with items extracted from the NEEL test | Other | 1:Sri Lankais, 2: Algerian, 3: Mali |
| ELAL testAn assessment of mother tongue with the ELAL of AVICENNE | Other | 1:Sri Lankais, 2: Algerian, 3: Mali |
| InterviewFor parents of children include in the study: A semi -structured interview | Other | 1:Sri Lankais, 2: Algerian, 3: Mali |
Primary outcome
Validation of an instrument of the first language assessment.
Time frame: at 54 months
Validation of "avicenne's ELAL": instrument of mother tongue assessment
1 secondary outcome
Impact of familial and transcultural factors
Time frame: at 54 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dalila REZZOUG, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Language, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of an instrument of the first language assessment. (time frame: at 54 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2021.