DDMR: Developmental Dyslexia and Remediation Methods

Sponsor
Fondation Lenval (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04028310
Collaborator
(none)
145
1
2
46.2
3.1

Study Details

Study Description

Brief Summary

At least, three theoretical frameworks are currently involved in therapeutic research in developmental dyslexia. Each theoretical framework relies on the type of underlying cognitive processes that is viewed as impaired: 1°) phonological processing, 2°) cross modal integration, 3°) visual attention processing. In this controlled and randomized study, three types of computerized training are combined in a multi-factorial remedial approach in 8 to 12 year old children with dyslexia. The main objective is to compare the effectiveness of this remedial approach which combines phonological, visual-attentional and cross-modal training with conventional non-intensive and non-specific rehabilitation

Condition or Disease Intervention/Treatment Phase
  • Other: Phonological
  • Other: Visual-attention
N/A

Detailed Description

Developmental dyslexia is defined as a specific and lasting reading learning disorder. This neurodevelopmental disorder has a severe impact on overall academic learning and behavior, compromises professional and social development and affects 10% of school-age children. As a public health problem, its diagnosis and management are still highly controversial, and the lack of scientific consensus leads to great heterogeneity in clinical practices and post-treatment outcomes. Three therapeutic axes guide research for developmental dyslexia. The first axis is based on phonological deficits. According to the phonological representation hypothesis, a specific deficit in the processing of phonological representations that support the identification of sounds is the cause of the reading disorder. The second axis focuses on attention-related cognitive deficits. According to the visuo-attention deficit hypothesis, a lack of the visuo-attention processing can be viewed as one of the explanatory causes of a dysfunction in letter identification and reading procedures. The third axis aims to achieve automatized processing for letter/sound association. According to the axis, a lack of cross-modal integration in word decoding is altered by a lack of simultaneous association between of a visual and an auditory stimulus.

Many studies attempted to exclusively validate selective remediation according to causal hypotheses that are mainly cross-modal, phonological or visuo-attentional. However, the evaluation of these underlying processing in dyslexic children shows great clinical heterogeneity since most of children simultaneously have the three deficits. Furthermore, no study evaluates the benefits of combining these different trainings on reading skills.

In this controlled and randomized study, three types of computerized training are combined in a multi-factorial remedial approach in 8 to 12 year old children with dyslexia. The main objective is to compare the effectiveness of this remedial approach which combines phonological, visual-attentional and cross-modal training with conventional non-intensive and non-specific rehabilitation.

The secondary objectives will be 1°) to compare the effectiveness on reading skills of a phonological training, versus a visuo-attentional training, 2°) to compare the effectiveness on reading skills from in the order of phonological and visuo-attentional training, 3°) to compare the evolution of performance in comprehension and written production at the end of the three training sessions and 4°) to evaluate child and parents' perception for the outcome of the reading disorder at the end of the training sessions using Likert scales, by means of a questionnaire. The analysis of the results will make possible to evaluate a remedial approach to dyslexia in a clinical context and to better understanding and management of written language disorders.

Study Design

Study Type:
Interventional
Actual Enrollment :
145 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Other
Official Title:
Developmental Dyslexia and Remediation Methods. Phonological, Visual-attentional and Cross-modal Approaches, a Multicentric Study.
Actual Study Start Date :
Oct 25, 2019
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Phonological group

Other: Phonological
Phase 1: intervention without targeted daily training (30 minutes/ week, for 8 weeks) Phase 2: intervention with targeted daily training Phonological training (15 minutes/ day, 5 days/week, for 8 weeks) Visuo-attentional training (15 minutes/ day, 5 days/week, for 8 weeks) Cross-modal training (15 minutes/ day, 5 days/week, for 8 weeks) Phase 3: stopping training sessions for 8 weeks

Experimental: visual-attention group

Other: Visual-attention
Phase 1: intervention without targeted daily training (30 minutes/ week, for 8 weeks) Phase 2: intervention with targeted daily training Visuo-attentional training (15 minutes/ day, 5 days/week, for 8 weeks) Phonological training (15 minutes/ day, 5 days/week, for 8 weeks) Cross-modal training (15 minutes/ day, 5 days/week, for 8 weeks) Phase 3: stopping training sessions for 8 weeks

Outcome Measures

Primary Outcome Measures

  1. reading skills effectiveness [26 weeks to baseline]

    measure of reading level (reading age) : accuracy (number of errors) and reading time (in seconds) in raw scores and standard deviation

Secondary Outcome Measures

  1. reading skills effectiveness 8 weeks [8 weeks to baseline]

    Measure of reading level : accuracy (error rates) and reading time (in milliseconds) in raw scores and standard deviations

  2. reading skills effectiveness 18 weeks [18 weeks to baseline]

    Measure of reading level : accuracy (error rates) and reading time (in milliseconds) in raw scores and standard deviations

  3. orthographic skills effectiveness [26 weeks to baseline]

    count of orthographic (number of errors) in raw scores and standard deviation

  4. reading comprehension skills effectiveness [26 weeks to baseline]

    measure of reading comprehension level (error rates) in raw scores and standard deviation

  5. perception of the evolution of the reading disorder [26 weeks to baseline]

    measure the perception of the evolution of the reading disorder by Likert scales : Number of items: 13 Score from 5 to 1 For example, "I like to read" a lot = 5, a lot = 4, normal" = 3, a little = 2, not at all = 1 Another example "it's easy to read", really very easy = 5, I do well = 4, normal = 3, a little difficult = 4, very difficult = 1 The maximum value 5 means that reading and learning are perceived very positively The minimum value 1 means that reading and learning are perceived very negatively Results: An increase in scores measured before and after the three training sessions means an improvement

Eligibility Criteria

Criteria

Ages Eligible for Study:
8 Years to 13 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Age ≥ 8 years old and ≤ at 13 years old;

  • Diagnosis of dyslexia validated by performances ≤ at -1.5 standard deviations from the mean on leximetric tests.

  • Diagnosis of mixed dyslexia validated by performances ≤ at -1.5 standard deviations from the mean for reading irregular words and pseudo-words in the Evalec© test.

  • Performance ≤ at -1.5 standard deviations from the mean for phonological (Evalec©) and visual-attentional tasks in the Evadys© and Sigl© tests.

  • Home equipped with a connected computer system for daily training.

  • Signing of informed consent by the parents

  • The child must be affiliated to a social security scheme

Exclusion Criteria:
  • Intellectual retardation, neurological disorders, pervasive developmental disorder;

  • Primary sensory deficit;

  • Educational deficiencies;

  • attention deficit hyperactivity disorder, dysphasia;

  • Previous daily phonological or visual-attentional training.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hôpitaux Pédiatriques de Nice CHU-Lenval Nice France

Sponsors and Collaborators

  • Fondation Lenval

Investigators

  • Principal Investigator: HARRAR-ESKINAZI KARINE, CERTA Fondation Lenval, Children Hospital of Nice CHU-LENVAL

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fondation Lenval
ClinicalTrials.gov Identifier:
NCT04028310
Other Study ID Numbers:
  • 19-HPNCL-02
First Posted:
Jul 22, 2019
Last Update Posted:
Jul 27, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 27, 2022