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

NCT05917496 | Recruiting

• 2 other identifiers: APHP2304232023-A00405-40
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Profound Congenital Deafness; Cochlear Implantation

Keywords

Profound congenital deafness; Early cochlear implantation; Language environment; Child's language development; Speech therapy assessment; Language ENvironment Analysis (LENA) tool

Outcome Measures

Primary Outcomes (3)

• Number of conversation turns

  Comparison of the variation in language environment for the number of conversation turns recorded at T1 and the number of conversation turns recorded at T2 after speech therapy support offered at T1 and based on data provided by the Language ENvironment Analysis (LENA) tool. Average numerical scores expressed in percentiles are produced at the end of the analysis. The individual scores are then compared with a standard expressed in percentiles.

  6 months

• Receptive lexical level

  Receptive lexical level measured by the speech therapy test (IFDC, French inventories of Communicative Development) at T1 and T2. Each child's individual result is given in percentiles according to chronological age. It is based on an evaluation sheet with benchmarks in percentiles (10th to 90th) or percentages.

  6 months

• Correlation between the number of conversation turns parameter and the receptive lexical level

  The correlation between the "conversation turns" parameter recorded at T1 and T2 and the receptive lexical level measured by the speech therapy test (IFDC, French inventories of Communicative Development) at T1 and T2 will be carried out.

  6 months

Secondary Outcomes (4)

• Link between 3 language environment parameters: adult words, child vocalization, exposure to electronic media and the receptive lexical level

  6 months

• Acceptability of the use of the LENA tool for children under 3 years

  24 months

• Protocolizing the individual strategies given to help and support parents to enrich their child's language environment

  6 months

• Family participation during speech therapy

  6 months

Study Arms (1)

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.

Other: LENA tool: Language ENvironment Analysis; Behavioral: Return of the analysis of the data of LENA

Interventions

LENA tool: Language ENvironment Analysis OTHER

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.

Patients

Return of the analysis of the data of LENA BEHAVIORAL

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.

Patients

Eligibility Criteria

• Age: 11 Months - 21 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children under 24 months with profound congenital deafness and having benefited from unilateral or bilateral cochlear implantation before 18 months of life inclusive, followed at Hôpital Necker-Enfants Maladies and who receive a speech therapy.

You may qualify if:

• Have profound congenital deafness
• Have been implanted between 8 months and 18 months
• Have had a unilateral or bilateral cochlear implant for 3 months
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hôpital Necker-Enfants Malades

Paris, 75015, France

RECRUITING

Related Publications (12)

• 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 BACKGROUND

• 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 BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• Dunn LM., Theriault-Whalen CM., Dunn LM. (1993). Echelle de Vocabulaire en Images Peabody. (EVIP). Toronto (Canada) : Psychan.

  BACKGROUND

• 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

  BACKGROUND

• 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.

  BACKGROUND

• Hart B. & Risley T. (1995). Meaningful differences in the everyday experience of young American children. Baltimore: Brookes.

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 10969127 BACKGROUND

• 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.

  PMID: 24030911 BACKGROUND

• Kern, S. & Gayraud, G., 2010,

  BACKGROUND

Study Officials

• Clara LEGENDRE, speech therapist

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

• Natalie LOUNDON, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Central Study Contacts

Clara LEGENDRE, speech therapist

CONTACT

1 71 39 67 96; clara.legendre@aphp.fr

Hélène MOREL

CONTACT

1 71 19 63 46; helene.morel@aphp.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: June 26, 2023
• Study Start: September 13, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)