Developmental Dyslexia and Remediation Methods

NCT04028310 | Completed

• 1 other identifier: 19-HPNCL-02
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

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

Conditions

Dyslexia, Developmental

Outcome Measures

Primary Outcomes (1)

• reading skills effectiveness

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

  26 weeks to baseline

Secondary Outcomes (5)

• reading skills effectiveness 8 weeks

  8 weeks to baseline

• reading skills effectiveness 18 weeks

  18 weeks to baseline

• orthographic skills effectiveness

  26 weeks to baseline

• reading comprehension skills effectiveness

  26 weeks to baseline

• perception of the evolution of the reading disorder

  26 weeks to baseline

Study Arms (2)

Phonological group

EXPERIMENTAL

Other: Phonological

visual-attention group

EXPERIMENTAL

Other: Visual-attention

Interventions

Phonological OTHER

* 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

Phonological group

Visual-attention OTHER

* 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

visual-attention group

Eligibility Criteria

• Age: 8 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Intellectual retardation, neurological disorders, pervasive developmental disorder;
• Primary sensory deficit;
• Educational deficiencies;
• attention deficit hyperactivity disorder, dysphasia;
• Previous daily phonological or visual-attentional training.

Sponsors & Collaborators

• Fondation Lenval: lead

Study Sites (1)

Hôpitaux Pédiatriques de Nice CHU-Lenval

Nice, France

Location

Related Publications (2)

• Darrot G, Gros A, Manera V, De Cara B, Faure S, Corveleyn X, Harrar-Eskinazi K. Effects of a developmental dyslexia remediation protocol based on the training of audio-phonological cognitive processes in dyslexic children with high intellectual potential: study protocol for a multiple-baseline single-case experimental design. BMC Pediatr. 2023 Aug 17;23(1):404. doi: 10.1186/s12887-023-04189-6.

  PMID: 37592217 DERIVED

• Harrar-Eskinazi KL, De Cara B, Leloup G, Nothelier J, Caci H, Ziegler JC, Faure S. Multimodal intervention in 8- to 13-year-old French dyslexic readers: Study protocol for a randomized multicenter controlled crossover trial. BMC Pediatr. 2022 Dec 28;22(1):741. doi: 10.1186/s12887-022-03701-8.

  PMID: 36578007 DERIVED

MeSH Terms

Conditions

Dyslexia

Condition Hierarchy (Ancestors)

Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Specific Learning Disorder; Learning Disabilities; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• HARRAR-ESKINAZI KARINE

  CERTA Fondation Lenval, Children Hospital of Nice CHU-LENVAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2019
• First Posted: July 22, 2019
• Study Start: October 25, 2019
• Primary Completion: December 12, 2022
• Study Completion: December 12, 2022
• Last Updated: September 29, 2023

Record last verified: 2023-09

Locations

FR (1)