Dyslexia, DevelopmentalDDMRNCT04028310
Developmental Dyslexia and Remediation Methods
A study testing Phonological and Visual-attention in people with Dyslexia, Developmental, run by Fondation Lenval at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 13 years
- Conditions the study is for
- Dyslexia, Developmental
- What is being tested?
- Phonological and Visual-attention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteFrance
- Study dates
- 25 Oct 2019to 12 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Intellectual retardation, neurological disorders, pervasive developmental disorder;
- Primary sensory deficit;
- Educational deficiencies;
- attention deficit hyperactivity disorder, dysphasia;
- Previous daily phonological or visual-attentional training.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Developmental Dyslexia and Remediation Methods. Phonological, Visual-attentional and Cross-modal Approaches, a Multicentric Study.
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
Read the 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.
- Conditions
- Dyslexia, Developmental
- Being tested
- Phonological, Visual-attention
- Medical subject headings
- Dyslexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhonologicalOther
- 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
Visual-attentionOther
- 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
| Study group | Role | What they receive |
|---|---|---|
| Phonological group | Experimental | Not described Receives: Other: Phonological |
| visual-attention group | Experimental | Not described Receives: Other: Visual-attention |
What is being measured
The primary outcome is the main question the study is designed to answer.
reading skills effectiveness
measure of reading level (reading age) : accuracy (number of errors) and reading time (in seconds) in raw scores and standard deviation
Measured: 26 weeks to baseline
Secondary outcomes (5)
reading skills effectiveness 8 weeks
Measure of reading level : accuracy (error rates) and reading time (in milliseconds) in raw scores and standard deviations
Measured: 8 weeks to baseline
reading skills effectiveness 18 weeks
Measure of reading level : accuracy (error rates) and reading time (in milliseconds) in raw scores and standard deviations
Measured: 18 weeks to baseline
orthographic skills effectiveness
count of orthographic (number of errors) in raw scores and standard deviation
Measured: 26 weeks to baseline
reading comprehension skills effectiveness
measure of reading comprehension level (error rates) in raw scores and standard deviation
Measured: 26 weeks to baseline
perception of the evolution of the reading disorder
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
Measured: 26 weeks to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2019
- Study start25 Oct 2019
- Primary completion12 Dec 2022
- Study completion12 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dyslexia, DevelopmentalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Lenval
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- HARRAR-ESKINAZI KARINE, Principal investigator, CERTA Fondation Lenval, Children Hospital of Nice CHU-LENVAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04028310
- Sponsor's protocol ID
- 19-HPNCL-02
- Acronym
- DDMR
- Status last verified
- Sep 2023
- First submitted
- 18 Jul 2019
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Harrar-Eskinazi KL, Denis-Noel A, De Cara B, Leloup G, Nothelier J, Caci H, Faure S, Ziegler JC. Back on track: remediating developmental dyslexia with a home-based multi-component program. Ann Dyslexia. 2026 Jun 30. doi: 10.1007/s11881-026-00378-x. Online ahead of print.
PubMed 42377862Darrot 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.
PubMed 37592217Harrar-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.
PubMed 36578007
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developmental Dyslexia and Remediation Methods. Phonological, Visual-attentional and Cross-modal Approaches, a Multicentric Study.
- ClinicalTrials.gov ID
- NCT04028310
- Acronym / sponsor ID
- DDMR / 19-HPNCL-02
- Conditions
- Dyslexia, Developmental
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Fondation LenvalUniversity, hospital or other
- Study start
- 25 Oct 2019 (actual)
- Primary completion
- 12 Dec 2022 (actual)
- Study completion
- 12 Dec 2022 (actual)
- First posted
- 22 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phonological group | Experimental | Other: Phonological |
| visual-attention group | Experimental | Other: Visual-attention |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- Intellectual retardation, neurological disorders, pervasive developmental disorder;
- Primary sensory deficit;
- Educational deficiencies;
- attention deficit hyperactivity disorder, dysphasia;
- Previous daily phonological or visual-attentional training.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Phonological group |
| 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 | Other | visual-attention group |
Primary outcome
reading skills effectiveness
Time frame: 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
5 secondary outcomes
reading skills effectiveness 8 weeks
Time frame: 8 weeks to baseline
reading skills effectiveness 18 weeks
Time frame: 18 weeks to baseline
orthographic skills effectiveness
Time frame: 26 weeks to baseline
reading comprehension skills effectiveness
Time frame: 26 weeks to baseline
perception of the evolution of the reading disorder
Time frame: 26 weeks to baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- Derived from this study: PubMed 42377862Harrar-Eskinazi KL, Denis-Noel A, De Cara B, Leloup G, Nothelier J, Caci H, Faure S, Ziegler JC. Back on track: remediating developmental dyslexia with a home-based multi-component program. Ann Dyslexia. 2026 Jun 30. doi: 10.1007/s11881-026-00378-x. Online ahead of print.
- Derived from this study: PubMed 37592217Darrot 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.
- Derived from this study: PubMed 36578007Harrar-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
HARRAR-ESKINAZI KARINE principal investigator
CERTA Fondation Lenval, Children Hospital of Nice CHU-LENVAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phonological and Visual-attention in people with Dyslexia, Developmental, run by Fondation Lenval at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reading skills effectiveness (time frame: 26 weeks to baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04028310, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2023.