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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04384952
Other study ID # APHP200214
Secondary ID IDRCB 2019-A0326
Status Completed
Phase N/A
First received
Last updated
Start date June 5, 2020
Est. completion date October 15, 2020

Study information

Verified date April 2020
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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."


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. "


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date October 15, 2020
Est. primary completion date October 15, 2020
Accepts healthy volunteers No
Gender All
Age group 8 Years to 13 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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.
Dyslexic's Holiday Workbook
Use of a special Dyslexic's holiday book, no parent-guided training.

Locations

Country Name City State
France Robert Debre Hospital Paris

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (1)

Kerjean L, Benard P, Peyre H. Parent-implemented intervention for children in third to fifth grade with dyslexia. Encephale. 2022 Oct 14:S0013-7006(22)00216-0. doi: 10.1016/j.encep.2022.08.016. Online ahead of print. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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) 4 weeks
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