DyslexiaREEDVACNCT04384952
Effectiveness of a Parent-administered Reading Therapy Program During Summer Break for Dyslexic Children
A study testing Parent-administered reading therapy. and Dyslexic's Holiday Workbook in people with Dyslexia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
"After summer break, the reading performance of dyslexic children declines more than those of non-dyslexic children. Indeed, during the summer, dyslexic children are less inclined to read and their consultations with speech therapist are usually suspended. Read more about this study
- Who is it for?
- Ages 8 to 13 years
- Conditions the study is for
- Dyslexia
- What is being tested?
- Parent-administered reading therapy. and Dyslexic's Holiday Workbook
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- 5 Jun 2020to 15 Oct 2020
- 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
- Schooled in Grade 3, 4 or 5 (CE2, CM1 ou CM2) at inclusion
- Diagnosis of developmental dyslexia with visual information treatment deficit, confirmed by the Reference Center for Learning Disabilities, Robert Debré Hospital
- Speech therapy for dyslexia that has started for at least 6 months
- No speech therapy during the 6-weeks intervention
- Family interest and availibility for 6 weeks durant summer break
- Informed consent signed by parents
- Affiliation to a social security scheme
Who cannot join
- Parents not fluent enough in French to read a text
- Patient IQ (intelligence quotient) < 70 (WISC test- Wechsler Intelligence Scale for Children)
- Other neurological pathology in the foreground
- Presenting hearing disorders or visual disorders not treated,
- Member of a sibling also eligible for the protocol (contamination bias)
- Beneficiary of State medical aid (AME)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial Comparing the Effect of a Parent-guided Speech and Language Therapy Program During the Summer Holidays With an Adapted Holiday Book on the Reading Level of Children With Visual-attentional Dyslexia
"After summer break, the reading performance of dyslexic children declines more than those of non-dyslexic children. Indeed, during the summer, dyslexic children are less inclined to read and their consultations with speech therapist are usually suspended.
Intensive speech therapy programs proved to be efficient during the summer, to maintain reading level of dyslexic children. However these programs are expensive and not easy to generalise. Some other studies tested reading therapy programs applied by parents at home. It proved to be effective and feasible.
Thus, the hypothesis of the present study is: a parent-administered reading therapy program during the summer break could stabilise the reading performance of dyslexic children after the summer. On the contrary the investigators assume the control group reading performance would decrease."
Read the detailed description
"Dyslexia is a specific learning disability characterised by reading difficulties, not caused by developmental, neurological or sensory (vision or hearing) disorders.
After summer break, the reading performance of dyslexic children declines more than those of non-dyslexic children. Indeed, during the summer, dyslexic children are less inclined to read and their consultations with speech therapist are usually suspended.
Intensive reading therapy programs proved to be efficient during the summer, to maintain reading level of dyslexic children. However these programs are expensive and not easy to generalise. Some other studies tested reading therapy programs applied by parents at home. It proved to be effective and feasible.
Thus, the hypothesis of the present study is: a parent-administered reading therapy program during the summer break could stabilise the reading performance of dyslexic children (grade 3 to 5) after the summer. On the contrary the investigators assume the control group reading performance would decrease.
With a controlled randomised trial, the investigators will compare the reading performance of two groups of dyslexic children with the same type of dyslexia (with visual information treatment deficit). All of them are diagnosed by the Reference Centre for learning disabilities (CRTLA), a Robert Debré Hospital's Unit, Paris (France).
Intensity and duration : 6 weeks during the summer break. 15 minutes/day, 5 times per week.
Intervention group : Parent-administered reading therapy program. Control group : Dyslexic's Holiday Workbook (Hatier Editor). This study's main objective consists in evaluating the effectiveness in reading performance of a parent-administered reading training program during the summer break for dyslexic children.
"
- Conditions
- Dyslexia
- Being tested
- Parent-administered reading therapy., Dyslexic's Holiday Workbook
- Medical subject headings
- Dyslexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent-administered reading therapy.Other
Parent-administered reading therapy program: 15min each day, 5 days a week during 6 weeks during the summer break. Repeted reading with feedback from the parent and time control.
Dyslexic's Holiday WorkbookOther
Use of a special Dyslexic's holiday book, no parent-guided training.
| Study group | Role | What they receive |
|---|---|---|
| Parent-administered reading therapy. | Experimental | Parent-administered reading therapy program: 15min each day, 5 days a week during 6 weeks during the summer break. Repeated reading with feedback from the parent and time control. Receives: Other: Parent-administered reading therapy. |
| Dyslexic's Holliday Workbook. | Active comparator | Use of a special Dys holiday book, no parent-guided training. Receives: Other: Dyslexic's Holiday Workbook |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring program effectiveness on reading performance (accuracy and speed of word reading)
Word Reading performance with French BALE Test. BALE (Batterie Analytique du Langage Ecrit). Measure of number of correct words read and speed of reading. Raw score for word reading performance (accuracy) : minimum 0 (worse outcomme, maximum 20 (better outcome)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start5 Jun 2020
- Primary completion15 Oct 2020
- Study completion15 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyslexiaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04384952
- Sponsor's protocol ID
- APHP200214
- Other IDs
- IDRCB 2019-A03260-57
- Acronym
- REEDVAC
- Status last verified
- Apr 2020
- First submitted
- 28 Apr 2020
- Last updated
- 3 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kerjean L, Benard P, Peyre H. Parent-implemented intervention for children in third to fifth grade with dyslexia. Encephale. 2023 Dec;49(6):589-595. doi: 10.1016/j.encep.2022.08.016. Epub 2022 Oct 15.
PubMed 36253171
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing the Effect of a Parent-guided Speech and Language Therapy Program During the Summer Holidays With an Adapted Holiday Book on the Reading Level of Children With Visual-attentional Dyslexia
- ClinicalTrials.gov ID
- NCT04384952
- Acronym / sponsor ID
- REEDVAC / APHP200214
- Conditions
- Dyslexia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 5 Jun 2020 (actual)
- Primary completion
- 15 Oct 2020 (actual)
- Study completion
- 15 Oct 2020 (actual)
- First posted
- 12 May 2020 (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.
"After summer break, the reading performance of dyslexic children declines more than those of non-dyslexic children. Indeed, during the summer, dyslexic children are less inclined to read and their consultations with speech therapist are usually suspended.
Intensive speech therapy programs proved to be efficient during the summer, to maintain reading level of dyslexic children. However these programs are expensive and not easy to generalise. Some other studies tested reading therapy programs applied by parents at home. It proved to be effective and feasible.
Thus, the hypothesis of the present study is: a parent-administered reading therapy program during the summer break could stabilise the reading performance of dyslexic children after the summer. On the contrary the investigators assume the control group reading performance would decrease."
Detailed description
"Dyslexia is a specific learning disability characterised by reading difficulties, not caused by developmental, neurological or sensory (vision or hearing) disorders.
After summer break, the reading performance of dyslexic children declines more than those of non-dyslexic children. Indeed, during the summer, dyslexic children are less inclined to read and their consultations with speech therapist are usually suspended.
Intensive reading therapy programs proved to be efficient during the summer, to maintain reading level of dyslexic children. However these programs are expensive and not easy to generalise. Some other studies tested reading therapy programs applied by parents at home. It proved to be effective and feasible.
Thus, the hypothesis of the present study is: a parent-administered reading therapy program during the summer break could stabilise the reading performance of dyslexic children (grade 3 to 5) after the summer. On the contrary the investigators assume the control group reading performance would decrease.
With a controlled randomised trial, the investigators will compare the reading performance of two groups of dyslexic children with the same type of dyslexia (with visual information treatment deficit). All of them are diagnosed by the Reference Centre for learning disabilities (CRTLA), a Robert Debré Hospital's Unit, Paris (France).
Intensity and duration : 6 weeks during the summer break. 15 minutes/day, 5 times per week.
Intervention group : Parent-administered reading therapy program. Control group : Dyslexic's Holiday Workbook (Hatier Editor). This study's main objective consists in evaluating the effectiveness in reading performance of a parent-administered reading training program during the summer break for dyslexic children.
"
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parent-administered reading therapy. | Experimental | Other: Parent-administered reading therapy.Parent-administered reading therapy program: 15min each day, 5 days a week during 6 weeks during the summer break. Repeated reading with feedback from the parent and time control. |
| Dyslexic's Holliday Workbook. | Active comparator | Other: Dyslexic's Holiday WorkbookUse of a special Dys holiday book, no parent-guided training. |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Schooled in Grade 3, 4 or 5 (CE2, CM1 ou CM2) at inclusion
- Diagnosis of developmental dyslexia with visual information treatment deficit, confirmed by the Reference Center for Learning Disabilities, Robert Debré Hospital
- Speech therapy for dyslexia that has started for at least 6 months
- No speech therapy during the 6-weeks intervention
- Family interest and availibility for 6 weeks durant summer break
Key exclusion criteria (6 listed)
- Parents not fluent enough in French to read a text
- Patient IQ (intelligence quotient) < 70 (WISC test- Wechsler Intelligence Scale for Children)
- Other neurological pathology in the foreground
- Presenting hearing disorders or visual disorders not treated,
- Member of a sibling also eligible for the protocol (contamination bias)
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 |
|---|---|---|
| Parent-administered reading therapy.Parent-administered reading therapy program: 15min each day, 5 days a week during 6 weeks during the summer break. Repeted reading with feedback from the parent and time control. | Other | Parent-administered reading therapy. |
| Dyslexic's Holiday WorkbookUse of a special Dyslexic's holiday book, no parent-guided training. | Other | Dyslexic's Holliday Workbook. |
Primary outcome
Measuring program effectiveness on reading performance (accuracy and speed of word reading)
Time frame: 4 weeks
Word Reading performance with French BALE Test. BALE (Batterie Analytique du Langage Ecrit). Measure of number of correct words read and speed of reading. Raw score for word reading performance (accuracy) : minimum 0 (worse outcomme, maximum 20 (better outcome)
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 3 Feb 2023.
- Results publication: PubMed 36253171Kerjean L, Benard P, Peyre H. Parent-implemented intervention for children in third to fifth grade with dyslexia. Encephale. 2023 Dec;49(6):589-595. doi: 10.1016/j.encep.2022.08.016. Epub 2022 Oct 15.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent-administered reading therapy. and Dyslexic's Holiday Workbook in people with Dyslexia, run by Assistance Publique - Hôpitaux de Paris 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 6 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 3 Feb 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?
Measuring program effectiveness on reading performance (accuracy and speed of word reading) (time frame: 4 weeks). 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 NCT04384952, which also lists 1 linked publication.
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 3 Feb 2023.