Analysis of Parental Support in Families Using the LENA After Early Cochlear Implantation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age11-21
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial 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.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
LENA tool: Language ENvironment Analysis
Other interventionRecording 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
BehavioralThe 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Patients2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
6 months2
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.
Time frame
6 months3
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.
Time frame
6 monthsSecondary outcomes
1
Link between 3 language environment parameters: adult words, child vocalization, exposure to electronic media and the receptive lexical level
To study the link between the 3 others language environment parameters (adult words, child vocalization, exposure to electronic media), evaluated by the LENA system and the receptive lexical level, measured by the standardized speech therapy test carried out at T1 and T2. 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.
Time frame
6 months2
Acceptability of the use of the LENA tool for children under 3 years
Evaluate the acceptability of the use of the LENA tool for children under 3 years old implanted between 8 and 18 months using the acceptability questionnaire completed by the parents concerning the use of the LENA system in their child at T1 and T2. An "acceptability" score will be calculated on the basis of this questionnaire and expressed as a percentage: the questionnaire consists of 6 questions, each answer worth 2, 1 or 0 points (i.e. a maximum gross score of 12 points), then the gross score divided by 6 and multiplied by 50 to obtain a percentage score (100% corresponding to excellent acceptability).
Time frame
24 months3
Protocolizing the individual strategies given to help and support parents to enrich their child's language environment
Analyze the individual results obtained from the language environment data collected from the LENA tool, in order to provide personalized advice to parents after T1 and T2, with the aim of improving their child's language environment. Comparison of individual scores at T1 and T2 for the 4 parameters evaluated by the LENA system ("adult words", "conversation turns", "child vocalizations" and "exposure to electronic media") with the means scores obtained. Carry out a process of protocolizing the individual strategies given to help and support parents in enriching their child's language environment.
Time frame
6 months4
Family participation during speech therapy
Comparison of scores from the family participation scale at T1 and T2. The speech and language therapist subjectively assesses the family's involvement by assigning a number corresponding to the level of involvement and motivation: the calibration is made from 1 (limited involvement) to 5 (ideal involvement).
Time frame
6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Assistance Publique - Hôpitaux de Paris
Lead sponsor
URC-CIC Paris Descartes Necker Cochin
Collaborator
Source ClinicalTrials.gov