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Multimodal intervention in 8- to 13-year-old French dyslexic readers: Study protocol for a randomized multicenter controlled crossover trial

BACKGROUND: Developmental dyslexia, a specific and long-lasting learning disorder that prevents children from becoming efficient and fluent readers, has a severe impact on academic learning and behavior and may compromise professional and social development. Most remediation studies are based on the...

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Autores principales: Harrar-Eskinazi, Karine Louna, De Cara, Bruno, Leloup, Gilles, Nothelier, Julie, Caci, Hervé, Ziegler, Johannes C., Faure, Sylvane
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9795620/
https://www.ncbi.nlm.nih.gov/pubmed/36578007
http://dx.doi.org/10.1186/s12887-022-03701-8
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author Harrar-Eskinazi, Karine Louna
De Cara, Bruno
Leloup, Gilles
Nothelier, Julie
Caci, Hervé
Ziegler, Johannes C.
Faure, Sylvane
author_facet Harrar-Eskinazi, Karine Louna
De Cara, Bruno
Leloup, Gilles
Nothelier, Julie
Caci, Hervé
Ziegler, Johannes C.
Faure, Sylvane
author_sort Harrar-Eskinazi, Karine Louna
collection PubMed
description BACKGROUND: Developmental dyslexia, a specific and long-lasting learning disorder that prevents children from becoming efficient and fluent readers, has a severe impact on academic learning and behavior and may compromise professional and social development. Most remediation studies are based on the explicit or implicit assumption that dyslexia results from a single cause related to either impaired phonological or visual-attentional processing or impaired cross-modal integration. Yet, recent studies show that dyslexia is multifactorial and that many dyslexics have underlying deficits in several domains. The originality of the current study is to test a remediation approach that trains skills in all three domains using different training methods that are tailored to an individual’s cognitive profile as part of a longitudinal intervention study. METHODS: This multicenter randomized crossover study will be conducted in three phases and will involve 120 dyslexic children between the ages of 8 and 13 years. The first phase serves as within-subject baseline period that lasts for 2 months. In this phase, all children undergo weekly speech-language therapy sessions without additional training at home (business-as-usual). During the second phase, all dyslexics receive three types of intensive interventions that last 2 month each: Phonological, visual-attentional, and cross-modal. The order of the first two interventions (phonological and visual-attentional) is swapped in two randomly assigned groups of 60 dyslexics each. This allows one to test the efficacy and additivity of each intervention (against baseline) and find out whether the order of delivery matters. During the third phase, the follow-up period, the intensive interventions are stopped, and all dyslexics will be tested after 2 months. Implementation fidelity will be assessed from the user data of the computerized intervention program and an “intention-to-treat” analysis will be performed on the children who quit the trial before the end. DISCUSSION: The main objective of this study is to assess whether the three types of intensive intervention (phase 2) improve reading skills compared to baseline (i.e., non-intensive intervention, phase 1). The secondary objectives are to evaluate the effectiveness of each intervention and to test the effects of order of delivery on reading intervention outcomes. Reading comprehension, spelling performance and reading disorder impact of dyslexic readers are assessed immediately before and after the multimodal intervention and 2 months post-intervention. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04028310. Registered on July 18, 2019. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12887-022-03701-8.
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spelling pubmed-97956202022-12-29 Multimodal intervention in 8- to 13-year-old French dyslexic readers: Study protocol for a randomized multicenter controlled crossover trial Harrar-Eskinazi, Karine Louna De Cara, Bruno Leloup, Gilles Nothelier, Julie Caci, Hervé Ziegler, Johannes C. Faure, Sylvane BMC Pediatr Study Protocol BACKGROUND: Developmental dyslexia, a specific and long-lasting learning disorder that prevents children from becoming efficient and fluent readers, has a severe impact on academic learning and behavior and may compromise professional and social development. Most remediation studies are based on the explicit or implicit assumption that dyslexia results from a single cause related to either impaired phonological or visual-attentional processing or impaired cross-modal integration. Yet, recent studies show that dyslexia is multifactorial and that many dyslexics have underlying deficits in several domains. The originality of the current study is to test a remediation approach that trains skills in all three domains using different training methods that are tailored to an individual’s cognitive profile as part of a longitudinal intervention study. METHODS: This multicenter randomized crossover study will be conducted in three phases and will involve 120 dyslexic children between the ages of 8 and 13 years. The first phase serves as within-subject baseline period that lasts for 2 months. In this phase, all children undergo weekly speech-language therapy sessions without additional training at home (business-as-usual). During the second phase, all dyslexics receive three types of intensive interventions that last 2 month each: Phonological, visual-attentional, and cross-modal. The order of the first two interventions (phonological and visual-attentional) is swapped in two randomly assigned groups of 60 dyslexics each. This allows one to test the efficacy and additivity of each intervention (against baseline) and find out whether the order of delivery matters. During the third phase, the follow-up period, the intensive interventions are stopped, and all dyslexics will be tested after 2 months. Implementation fidelity will be assessed from the user data of the computerized intervention program and an “intention-to-treat” analysis will be performed on the children who quit the trial before the end. DISCUSSION: The main objective of this study is to assess whether the three types of intensive intervention (phase 2) improve reading skills compared to baseline (i.e., non-intensive intervention, phase 1). The secondary objectives are to evaluate the effectiveness of each intervention and to test the effects of order of delivery on reading intervention outcomes. Reading comprehension, spelling performance and reading disorder impact of dyslexic readers are assessed immediately before and after the multimodal intervention and 2 months post-intervention. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04028310. Registered on July 18, 2019. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12887-022-03701-8. BioMed Central 2022-12-28 /pmc/articles/PMC9795620/ /pubmed/36578007 http://dx.doi.org/10.1186/s12887-022-03701-8 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Harrar-Eskinazi, Karine Louna
De Cara, Bruno
Leloup, Gilles
Nothelier, Julie
Caci, Hervé
Ziegler, Johannes C.
Faure, Sylvane
Multimodal intervention in 8- to 13-year-old French dyslexic readers: Study protocol for a randomized multicenter controlled crossover trial
title Multimodal intervention in 8- to 13-year-old French dyslexic readers: Study protocol for a randomized multicenter controlled crossover trial
title_full Multimodal intervention in 8- to 13-year-old French dyslexic readers: Study protocol for a randomized multicenter controlled crossover trial
title_fullStr Multimodal intervention in 8- to 13-year-old French dyslexic readers: Study protocol for a randomized multicenter controlled crossover trial
title_full_unstemmed Multimodal intervention in 8- to 13-year-old French dyslexic readers: Study protocol for a randomized multicenter controlled crossover trial
title_short Multimodal intervention in 8- to 13-year-old French dyslexic readers: Study protocol for a randomized multicenter controlled crossover trial
title_sort multimodal intervention in 8- to 13-year-old french dyslexic readers: study protocol for a randomized multicenter controlled crossover trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9795620/
https://www.ncbi.nlm.nih.gov/pubmed/36578007
http://dx.doi.org/10.1186/s12887-022-03701-8
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