Analysis of Parental Support in Families Using the LENA After Early Cochlear Implantation
NCT ID: NCT05917496
Last Updated: 2025-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
30 participants
OBSERVATIONAL
2024-09-13
2026-07-31
Brief Summary
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The purpose of this study is to analyze the effect of speech therapy parental support using the data provided by the Language ENvironment Analysis (LENA) tool, in a pediatric population implanted early, i.e. before the age of 18 months and aged under 24 months inclusive at the start of their participation in the study.
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Detailed Description
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The purpose of this study is to analyze the effect of speech therapy parental support using the data provided by the Language ENvironment Analysis (LENA) tool, in a pediatric population implanted early, i.e. before the age of 18 months and aged under 24 months inclusive at the start of their participation in the study.
The LENA tool was validated in French version in 2015. It is a system of recording and automatic analysis of the language environment of the child using a box worn for 10-16 hours, with a minimum of 10 consecutive hours. For the study, the families make 2 separate recordings of 6 months at home (T1 and T2) then, a centralized analysis of all the data is carried out by the speech therapist using adapted software, the LENA Pro Version Software v3.4, during the times T1 and T2. The return of the analysis of the data collected via the LENA will be made to the family after T1 and after T2.
The parameters resulting from this analysis relate to four domains: "adult words", "conversation turns", "child vocalizations" and "exposure to electronic media". Average numerical scores expressed in percentiles are published at the end of the analysis. Individual scores are then compared to a standard expressed as percentiles. The content of the conversations will not be listened to and only numerical scores will be used for each of the parameters studied and obtained by computer analysis.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Patients
Children aged 11 months to 21 months on the day of inclusion in the study, with profound congenital deafness and having benefited from unilateral or bilateral cochlear implantation before 18 months of life inclusive, followed at Necker-Enfants Malades hospital and who receive a speech therapy.
LENA tool: Language ENvironment Analysis
Recording of the language environment of the child at home, in daily environment, with the LENA.
The parameters recorded relate to four domains: "adult words", "conversation turns", "child vocalizations" and "exposure to electronic media".
The LENA box is worn for 10-16 hours, with a minimum of 10 consecutive hours. the families make 2 separate recordings of 6 months at T1 and T2.
Return of the analysis of the data of LENA
The analysis of the LENA data is carried out by the speech therapist using the LENA Pro Version Software v3.4, during the times T1 and T2. The return of the analysis of the data collected via the LENA will be made to the family of the patient after T1 and after T2 and personalized advice will then be given to parents with the aim of improving their child's language skills.
Interventions
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LENA tool: Language ENvironment Analysis
Recording of the language environment of the child at home, in daily environment, with the LENA.
The parameters recorded relate to four domains: "adult words", "conversation turns", "child vocalizations" and "exposure to electronic media".
The LENA box is worn for 10-16 hours, with a minimum of 10 consecutive hours. the families make 2 separate recordings of 6 months at T1 and T2.
Return of the analysis of the data of LENA
The analysis of the LENA data is carried out by the speech therapist using the LENA Pro Version Software v3.4, during the times T1 and T2. The return of the analysis of the data collected via the LENA will be made to the family of the patient after T1 and after T2 and personalized advice will then be given to parents with the aim of improving their child's language skills.
Eligibility Criteria
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Inclusion Criteria
* Have been implanted between 8 months and 18 months
* Have had a unilateral or bilateral cochlear implant for 3 months
* Be between 11 months and 21 months old on the day of inclusion
* Constant wearing of the implant
* Benefit from speech therapy
* Have a French-speaking parent
* Information and non-opposition of holders of parental authority to participate in the study
Exclusion Criteria
* Micro-cochlea or partial insertion of the electrode bundle
* CHARGE syndrome (acronym for Coloboma, Heart defect, Atresia choanae, Retarded growth and development, Genital hypoplasia, Ear anomalies/deafness or in French coloboma, cardiac malformation, choanal atresia, growth retardation and/or mental retardation, genital hypoplasia, ear abnormalities/deafness)
* Deafness with significant central involvement (cytomegalovirus, meningitis)
* Proven major disorders that can impact language development (Autism Spectrum Disorder, mental retardation, etc.)
* Non-daily wearing of the cochlear implant
* Proven uncorrected visual disturbances interfering with the performance of language level assessment tests
11 Months
21 Months
ALL
No
Sponsors
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URC-CIC Paris Descartes Necker Cochin
OTHER
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Clara LEGENDRE, speech therapist
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Natalie LOUNDON, MD, PhD
Role: STUDY_DIRECTOR
Assistance Publique - Hôpitaux de Paris
Locations
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Hôpital Necker-Enfants Malades
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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References
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Ambrose SE, VanDam M, Moeller MP. Linguistic input, electronic media, and communication outcomes of toddlers with hearing loss. Ear Hear. 2014 Mar-Apr;35(2):139-47. doi: 10.1097/AUD.0b013e3182a76768.
Canault M, Le Normand MT, Foudil S, Loundon N, Thai-Van H. Reliability of the Language ENvironment Analysis system (LENA) in European French. Behav Res Methods. 2016 Sep;48(3):1109-24. doi: 10.3758/s13428-015-0634-8.
Canault, M., Le Normand, M.-T., & Thai Van, H. (2017). LENATM (Language ENvironment Analysis System) : Un système de reconnaissance automatique de la parole et de l'environnement langagier de l'enfant. Enfance, 2(2), 199 216. https://doi.org/10.3917/enf1.172.0199
Coquet, F., Roustit, J. (2009).Batterie EVALO 2-6 : un nouvel outil d'EVAluation du développement du Langage Oral chez l'enfant de 2 ans 3 mois à 6 ans 3 mois. UPLF Infos, janvier. Union Professionnelle des Logopèdes Francophones. Belgique
Dunn LM., Theriault-Whalen CM., Dunn LM. (1993). Echelle de Vocabulaire en Images Peabody. (EVIP). Toronto (Canada) : Psychan.
Gilkerson J. & Richards J. A. (2009) The power of talk: Impact of adult talk, conversational turns, and TV during the critical 0-4 years of child development (Technical Report LTR-01-2). Retrieved from: http://www.lenababy.com/pdf/The_Power_of_Talk.pdf
Fenson L., Dale P., Reznick S., Thal D., Bates E., Hartung J., Tethick S., Reilly J. : MacArthur Communicative Development Inventories : User's guide and technical manual, San Diego, CA, Singular Publishing Group, 1993.
Hart B. & Risley T. (1995). Meaningful differences in the everyday experience of young American children. Baltimore: Brookes.
Haute Autorité de Santé. (2009, décembre). Recommandations de bonne pratique : surdité de l'enfant : accompagnement des familles et suivi de l'enfant de 0 à 6 ans, hors accompagnement scolaire. HYPE://www.has-sante.fr/jcms/c_922867/fr/surdite-de-l-enfant-accompagnement-des- familles-et-suivi-de-l-enfant-de-0-a-6-ans-hors-accompagnement-scolaire
Moeller MP. Early intervention and language development in children who are deaf and hard of hearing. Pediatrics. 2000 Sep;106(3):E43. doi: 10.1542/peds.106.3.e43.
Moeller MP, Carr G, Seaver L, Stredler-Brown A, Holzinger D. Best practices in family-centered early intervention for children who are deaf or hard of hearing: an international consensus statement. J Deaf Stud Deaf Educ. 2013 Oct;18(4):429-45. doi: 10.1093/deafed/ent034.
Kern, S. & Gayraud, G., 2010,
Other Identifiers
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2023-A00405-40
Identifier Type: OTHER
Identifier Source: secondary_id
APHP230423
Identifier Type: -
Identifier Source: org_study_id
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