NCT04384952

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."

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 12, 2020

Completed
24 days until next milestone

Study Start

First participant enrolled

June 5, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2020

Completed
Last Updated

February 3, 2023

Status Verified

April 1, 2020

Enrollment Period

4 months

First QC Date

April 28, 2020

Last Update Submit

February 1, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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.

Other: Parent-administered reading therapy.

Dyslexic's Holliday Workbook.

ACTIVE COMPARATOR

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

Other: Dyslexic's Holiday Workbook

Interventions

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.

Parent-administered reading therapy.

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

Dyslexic's Holliday Workbook.

Eligibility Criteria

Age8 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Robert Debre Hospital

Paris, 75019, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Dyslexia

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSpecific Learning DisorderLearning DisabilitiesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Single Blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2020

First Posted

May 12, 2020

Study Start

June 5, 2020

Primary Completion

October 15, 2020

Study Completion

October 15, 2020

Last Updated

February 3, 2023

Record last verified: 2020-04

Locations