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Effectiveness of a Parent-administered Reading Therapy Program During Summer Break for Dyslexic Children (REEDVAC)

Primary Purpose

Dyslexia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Parent-administered reading therapy.
Dyslexic's Holiday Workbook
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslexia

Eligibility Criteria

8 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Robert Debre Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Parent-administered reading therapy.

Dyslexic's Holliday Workbook.

Arm Description

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.

Use of a special Dys holiday book, no parent-guided training.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
April 28, 2020
Last Updated
February 1, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT04384952
Brief Title
Effectiveness of a Parent-administered Reading Therapy Program During Summer Break for Dyslexic Children
Acronym
REEDVAC
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
June 5, 2020 (Actual)
Primary Completion Date
October 15, 2020 (Actual)
Study Completion Date
October 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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."
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. "

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslexia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Single Blind
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Parent-administered reading therapy.
Arm Type
Experimental
Arm Description
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.
Arm Title
Dyslexic's Holliday Workbook.
Arm Type
Active Comparator
Arm Description
Use of a special Dys holiday book, no parent-guided training.
Intervention Type
Other
Intervention Name(s)
Parent-administered reading therapy.
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Dyslexic's Holiday Workbook
Intervention Description
Use of a special Dyslexic's holiday book, no parent-guided training.
Primary Outcome Measure Information:
Title
Measuring program effectiveness on reading performance (accuracy and speed of word reading)
Description
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)
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Robert Debre Hospital
City
Paris
ZIP/Postal Code
75019
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
36253171
Citation
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.
Results Reference
result

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Effectiveness of a Parent-administered Reading Therapy Program During Summer Break for Dyslexic Children

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