- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04384952
Effectiveness of a Parent-administered Reading Therapy Program During Summer Break for Dyslexic Children (REEDVAC)
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."
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Paris, France, 75019
- Robert Debre Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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.
|
Active Comparator: Dyslexic's Holliday Workbook.
Use of a special Dys holiday book, no parent-guided training.
|
Use of a special Dyslexic's holiday book, no parent-guided training.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
4 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- APHP200214
- IDRCB 2019-A03260-57 (Other Identifier: ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dyslexia
-
Catholic University of the Sacred HeartFondazione Policlinico Universitario Agostino Gemelli IRCCS; Fondazione I.R...Enrolling by invitationDevelopmental DyslexiaItaly
-
University of ZurichUnknown
-
Bambino Gesù Hospital and Research InstituteRecruitingDevelopmental DyslexiaItaly
-
Bambino Gesù Hospital and Research InstituteEnrolling by invitationDevelopmental DyslexiaItaly
-
Scalab CNRS 9193UnknownDevelopmental DyslexiaFrance
-
Catholic University of the Sacred HeartUnknown
-
University Hospital, ToursCompleted
-
IRCCS Eugenio MedeaFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico; University of MilanRecruiting
-
Georgia State UniversityMedical University of South Carolina; National Institutes of Health (NIH)CompletedDevelopmental Reading Disorder | Dyslexia, DevelopmentalUnited States
-
Università Vita-Salute San RaffaeleRecruiting
Clinical Trials on Parent-administered reading therapy.
-
McGill UniversityUnknownDyslexia | Developmental Articulation Disorder | Speech Articulation Disorder | Phonological ImpairmentCanada
-
The Hong Kong Polytechnic UniversityRecruiting
-
The Hong Kong Polytechnic UniversityUnknown
-
Children's Hospital Medical Center, CincinnatiActive, not recruitingParent-Child Relations | Language Development | LiteracyUnited States
-
Florida International UniversityLotus HouseCompletedParenting | Behavior ProblemUnited States
-
Johns Hopkins UniversityNational Institute of Nursing Research (NINR); University of Iowa; Hugo W. Moser...Completed
-
Ohio UniversityNational Institute of Mental Health (NIMH)CompletedDepression | HIV InfectionsUnited States
-
University of British ColumbiaRegistered Massage Therapists Association of British ColumbiaCompleted
-
Eunice Kennedy Shriver National Institute of Child...CompletedBrain Injuries | Cerebrovascular Accident | Dyslexia, AcquiredUnited States