Analysis of Parental Support in Families Using the LENA After Early Cochlear Implantation

Обзор

The language environment that influences the child's language development has been studied using different subjective tools, mainly audio and/or video recording and manual transcriptions. The linguistic results of the implanted deaf child are dependent on the age at the implant, but also on the auditory and linguistic stimulation in the first months following the placement of the implant. Parents are the main actors in the child's language development. Professionals can rely on the LENA tool: Language ENvironment Analysis, which objectifies the language environment of the child at home in his daily environment. It is possible to obtain statistics on the number of adult words received by the child, the number of words produced by the child as well as the exposure to media and noise. On the basis of this quantitative data, the family can be supported in an attempt to optimize the conditions for receiving their child's speech. 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.

Подробное описание

The language environment that influences the child's language development has been studied using different subjective tools, mainly audio and/or video recording and manual transcriptions. The linguistic results of the implanted deaf child are dependent on the age at the implant, but also on the auditory and linguistic stimulation in the first months following the placement of the implant. Parents are the main actors in the child's language development. Professionals can rely on the LENA tool: Language ENvironment Analysis, which objectifies the language environment of the child at home in daily environment. On the basis of this quantitative data provided by the LENA, the family can be supported in an attempt to optimize the conditions for receiving their child's speech.

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.

Вмешательства

• Другое 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.
• Поведенческое 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.

Первичные конечные точки

• Number of conversation turns [Срок оценки: 6 months]
• Receptive lexical level [Срок оценки: 6 months]
• Correlation between the number of conversation turns parameter and the receptive lexical level [Срок оценки: 6 months]

Вторичные конечные точки (4)

• Link between 3 language environment parameters: adult words, child vocalization, exposure to electronic media and the receptive lexical level [Срок оценки: 6 months]
• Acceptability of the use of the LENA tool for children under 3 years [Срок оценки: 24 months]
• Protocolizing the individual strategies given to help and support parents to enrich their child's language environment [Срок оценки: 6 months]
• Family participation during speech therapy [Срок оценки: 6 months]

Критерии участия

Критерии включения

• Have profound congenital deafness
• 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

Критерии исключения

• Syndromic deafness or auditory nerve aplasia
• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Франция · 1 центр

• Hôpital Necker-Enfants Malades — Paris

Публикации

• 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. PMID 24441740
• 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. PMID 26174716
• 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.

Идентификаторы

NCT: NCT05917496 · APHP230423 · 2023-A00405-40

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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