search
Back to results

Usefulness of an Assistive Technology Training Program for Adolscents With Dyslexia (FormONC)

Primary Purpose

Dyslexia, Adolescent

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Training
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dyslexia focused on measuring dyslexic adolescent, dyslexia, education, assistive technology

Eligibility Criteria

8 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: adolescents with dyslexia normal schooling (not in a specialized establishment) with attribution of assistive technology less than 3 months or planned soon or low usage Exclusion Criteria: oral disabilities hindering intelligibility physical disabilities (hands) hindering use of AT auditive and visual disabilities

Sites / Locations

  • DesmaisonsRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Training

Arm Description

Program of training of use of assistive technology

Outcomes

Primary Outcome Measures

Reading skills without assistive technology before training: number of words read
minimum 0 and maximum 152, higher scores mean a better outcome
Reading skills without assistive technology before training: number of misread
minimum 0 and maximum 152, higher scores mean a worse outcome
Reading skills without assistive technology before training: time to read
(in seconds, higher times mean a worse outcome)
Reading comprehension skills without assistive technology before training: titles choices
(higher scores mean a better outcome, minimum 0 and maximum 6)
Reading comprehension skills without assistive technology before training: right or wrong
(higher scores mean a better outcome: minimum 0 and maximum 8)
Reading comprehension skills without assistive technology before training: choice of the good answer
(higher scores mean a better outcome:minimum 0 and maximum 4).
Reading effectiveness without assistive technology before training
sum (minimum 0 and maximum 172: higher scores mean a better outcome) of number of correct read words (minimum 0 and maximum 152) plus comprehension score (minimum 0 and maximum 18) plus reading score (0: failed, 1: partially succeded, 2 succeded)
Reading skills without assistive technology after training: number of words read
(minimum 0 and maximum 152, higher scores mean a better outcome)
Reading skills without assistive technology after training: number of misread
(minimum 0 and maximum 152, higher scores mean a worse outcome)
Reading skills without assistive technology after training: time to read
(in seconds, higher times mean a worse outcome)
Reading comprehension skills without assistive technology after training: titles choices
(higher scores mean a better outcome, minimum 0 and maximum 6)
Reading comprehension skills without assistive technology after training: right or wrong
(higher scores mean a better outcome: minimum 0 and maximum 8)
Reading comprehension skills without assistive technology after training: choice of the good answer
(higher scores mean a better outcome:minimum 0 and maximum 4).
Reading effectiveness without assistive technology after training
sum (minimum 0 and maximum 172: higher scores mean a better outcome) of number of correct read words (minimum 0 and maximum 152) plus comprehension score (minimum 0 and maximum 18) plus reading score (0: failed, 1: partially succeded, 2 succeded)
Reading skills with assistive technology before training: number of words read
(minimum 0 and maximum 152, higher scores mean a better outcome)
Reading skills with assistive technology before training: number of misread
(minimum 0 and maximum 152, higher scores mean a worse outcome)
Reading skills with assistive technology before training: time to read
(in seconds, higher times mean a worse outcome)
Reading comprehension skills with assistive technology before training: titles choices
(higher scores mean a better outcome, minimum 0 and maximum 6)
Reading comprehension skills with assistive technology before training: right or wrong
(higher scores mean a better outcome: minimum 0 and maximum 8)
Reading comprehension skills with assistive technology before training: choice of the good answer
(higher scores mean a better outcome:minimum 0 and maximum 4).
Reading effectiveness with assistive technology before training
sum (minimum 0 and maximum 172: higher scores mean a better outcome) of number of correct read words (minimum 0 and maximum 152) plus comprehension score (minimum 0 and maximum 18) plus reading score (0: failed, 1: partially succeded, 2 succeded)
Reading skills with assistive technology after training: number of words read
(minimum 0 and maximum 152, higher scores mean a better outcome)
Reading skills with assistive technology after training: number of misread
(minimum 0 and maximum 152, higher scores mean a worse outcome)
Reading skills with assistive technology after training: time to read
(in seconds, higher times mean a worse outcome)
Reading comprehension skills with assistive technology after training: titles choices
(higher scores mean a better outcome, minimum 0 and maximum 6)
Reading comprehension skills with assistive technology after training: right or wrong
(higher scores mean a better outcome: minimum 0 and maximum 8)
Reading comprehension skills with assistive technology after training: choice of the good answer
(higher scores mean a better outcome:minimum 0 and maximum 4).
Reading effectiveness with assistive technology after training
sum (minimum 0 and maximum 172: higher scores mean a better outcome) of number of correct read words (minimum 0 and maximum 152) plus comprehension score (minimum 0 and maximum 18) plus reading score (0: failed, 1: partially succeded, 2 succeded)
Written skills without assistive technology before training
Number of correct written words (handwriting) in 3 minutes (higher scores mean a better outcome) Number of incorrect written words (handwriting) in 3 minutes (higher scores mean a worse outcome)
Written skills without assistive technology after training
Number of correct written words (handwriting) in 3 minutes (higher scores mean a better outcome) Number of incorrect written words (handwriting) in 3 minutes (higher scores mean a worse outcome)
Written skills with assistive technology before training
Number of correct written words in 3 minutes (higher scores mean a better outcome) Number of incorrect written words in 3 minutes (higher scores mean a worse outcome)
Written skills with assistive technology after training
Number of correct written words in 3 minutes (higher scores mean a better outcome) Number of incorrect written words in 3 minutes (higher scores mean a worse outcome)

Secondary Outcome Measures

Autonomy before training
Autonomy in the daily life (number of help's need) (higher scores mean a worse outcome)
Autonomy after training
Autonomy in the daily life (number of help's need) (higher scores mean a worse outcome)
Effectiveness of assistive technology utilization before training: Frequency of use
(minutes per week) (higher scores mean a better outcome)
Effectiveness of assistive technology utilization before training: Number of different utilization locations
(home, school, …) (higher scores mean a better outcome)
Effectiveness of assistive technology utilization before training: Number of different accomplished tasks
(games, homework, messaging, social networks, …) (higher scores mean a better outcome)
Effectiveness of assistive technology utilization after training: Frequency of use
(minutes per week) (higher scores mean a better outcome)
Effectiveness of assistive technology utilization after training: Number of different utilization locations
(home, school, …) (higher scores mean a better outcome)
Effectiveness of assistive technology utilization after training: Number of different accomplished tasks
(games, homework, messaging, social networks, …) (higher scores mean a better outcome)

Full Information

First Posted
April 19, 2021
Last Updated
November 24, 2022
Sponsor
University Hospital, Caen
search

1. Study Identification

Unique Protocol Identification Number
NCT05636813
Brief Title
Usefulness of an Assistive Technology Training Program for Adolscents With Dyslexia
Acronym
FormONC
Official Title
Usefulness of an Assistive Technology Training Program for Adolescents With Dyslexia: Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 8, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen

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
Specific Written Language Disorders (SWLD) are severe and lasting impairments in the development of written language that affect approximately 10% of the school-age population.Concerned patients don't have any intellectual disability. Speech therapy help them to improve their language skills but also to compensate for their difficulties. School environment is one of the places where these disorders can constitute a real handicap. Given the prevalence of disorders, governments but also supra-governmental authorities have promoted educational integration of the concerned patients around the world. In France, different systems exist to help these patients with SWLD to follow an education that allows them to update their capacities as much as possible. School facilities are proposed such as attribution of Assistive Technology (AT). Nevertheless, these facilities have some limitations. Concerning AT, several studies have shown the benefits for patients with dyslexia such as a better use of them. However, there were some limitations in their use and their usefulness. The lack of use training is one of the barriers cited by patients and caregivers (parents and teachers). Assistive Technology training exists for patients with dyslexia but very few studies have measured their influence on their performance in written language. Moreover, these studies did not take into account the previous level of computer practice nor the natural appropriation of the AT (ie: anyone can appropriate themselves). It is therefore difficult to affirm the specificity of the training's influence. This study aims to assess the usefulness of AT training on the written language performance of adolescents with dyslexia. This work will study teenager's autonomy and how they use these tools.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslexia, Adolescent
Keywords
dyslexic adolescent, dyslexia, education, assistive technology

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pilot, pronostic, open-label, non-randomized, descriptive, study
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Training
Arm Type
Experimental
Arm Description
Program of training of use of assistive technology
Intervention Type
Other
Intervention Name(s)
Training
Intervention Description
Patients are trained to use AT (2 sessions of 4 hours). Written langage skills, autonomy, the use are evaluated before and after training.
Primary Outcome Measure Information:
Title
Reading skills without assistive technology before training: number of words read
Description
minimum 0 and maximum 152, higher scores mean a better outcome
Time Frame
9 weeks
Title
Reading skills without assistive technology before training: number of misread
Description
minimum 0 and maximum 152, higher scores mean a worse outcome
Time Frame
9 weeks
Title
Reading skills without assistive technology before training: time to read
Description
(in seconds, higher times mean a worse outcome)
Time Frame
9 weeks
Title
Reading comprehension skills without assistive technology before training: titles choices
Description
(higher scores mean a better outcome, minimum 0 and maximum 6)
Time Frame
9 weeks
Title
Reading comprehension skills without assistive technology before training: right or wrong
Description
(higher scores mean a better outcome: minimum 0 and maximum 8)
Time Frame
9 weeks
Title
Reading comprehension skills without assistive technology before training: choice of the good answer
Description
(higher scores mean a better outcome:minimum 0 and maximum 4).
Time Frame
9 weeks
Title
Reading effectiveness without assistive technology before training
Description
sum (minimum 0 and maximum 172: higher scores mean a better outcome) of number of correct read words (minimum 0 and maximum 152) plus comprehension score (minimum 0 and maximum 18) plus reading score (0: failed, 1: partially succeded, 2 succeded)
Time Frame
9 weeks
Title
Reading skills without assistive technology after training: number of words read
Description
(minimum 0 and maximum 152, higher scores mean a better outcome)
Time Frame
9 weeks
Title
Reading skills without assistive technology after training: number of misread
Description
(minimum 0 and maximum 152, higher scores mean a worse outcome)
Time Frame
9 weeks
Title
Reading skills without assistive technology after training: time to read
Description
(in seconds, higher times mean a worse outcome)
Time Frame
9 weeks
Title
Reading comprehension skills without assistive technology after training: titles choices
Description
(higher scores mean a better outcome, minimum 0 and maximum 6)
Time Frame
9 weeks
Title
Reading comprehension skills without assistive technology after training: right or wrong
Description
(higher scores mean a better outcome: minimum 0 and maximum 8)
Time Frame
9 weeks
Title
Reading comprehension skills without assistive technology after training: choice of the good answer
Description
(higher scores mean a better outcome:minimum 0 and maximum 4).
Time Frame
9 weeks
Title
Reading effectiveness without assistive technology after training
Description
sum (minimum 0 and maximum 172: higher scores mean a better outcome) of number of correct read words (minimum 0 and maximum 152) plus comprehension score (minimum 0 and maximum 18) plus reading score (0: failed, 1: partially succeded, 2 succeded)
Time Frame
9 weeks
Title
Reading skills with assistive technology before training: number of words read
Description
(minimum 0 and maximum 152, higher scores mean a better outcome)
Time Frame
9 weeks
Title
Reading skills with assistive technology before training: number of misread
Description
(minimum 0 and maximum 152, higher scores mean a worse outcome)
Time Frame
9 weeks
Title
Reading skills with assistive technology before training: time to read
Description
(in seconds, higher times mean a worse outcome)
Time Frame
9 weeks
Title
Reading comprehension skills with assistive technology before training: titles choices
Description
(higher scores mean a better outcome, minimum 0 and maximum 6)
Time Frame
9 weeks
Title
Reading comprehension skills with assistive technology before training: right or wrong
Description
(higher scores mean a better outcome: minimum 0 and maximum 8)
Time Frame
9 weeks
Title
Reading comprehension skills with assistive technology before training: choice of the good answer
Description
(higher scores mean a better outcome:minimum 0 and maximum 4).
Time Frame
9 weeks
Title
Reading effectiveness with assistive technology before training
Description
sum (minimum 0 and maximum 172: higher scores mean a better outcome) of number of correct read words (minimum 0 and maximum 152) plus comprehension score (minimum 0 and maximum 18) plus reading score (0: failed, 1: partially succeded, 2 succeded)
Time Frame
9 weeks
Title
Reading skills with assistive technology after training: number of words read
Description
(minimum 0 and maximum 152, higher scores mean a better outcome)
Time Frame
9 weeks
Title
Reading skills with assistive technology after training: number of misread
Description
(minimum 0 and maximum 152, higher scores mean a worse outcome)
Time Frame
9 weeks
Title
Reading skills with assistive technology after training: time to read
Description
(in seconds, higher times mean a worse outcome)
Time Frame
9 weeks
Title
Reading comprehension skills with assistive technology after training: titles choices
Description
(higher scores mean a better outcome, minimum 0 and maximum 6)
Time Frame
9 weeks
Title
Reading comprehension skills with assistive technology after training: right or wrong
Description
(higher scores mean a better outcome: minimum 0 and maximum 8)
Time Frame
9 weeks
Title
Reading comprehension skills with assistive technology after training: choice of the good answer
Description
(higher scores mean a better outcome:minimum 0 and maximum 4).
Time Frame
9 weeks
Title
Reading effectiveness with assistive technology after training
Description
sum (minimum 0 and maximum 172: higher scores mean a better outcome) of number of correct read words (minimum 0 and maximum 152) plus comprehension score (minimum 0 and maximum 18) plus reading score (0: failed, 1: partially succeded, 2 succeded)
Time Frame
9 weeks
Title
Written skills without assistive technology before training
Description
Number of correct written words (handwriting) in 3 minutes (higher scores mean a better outcome) Number of incorrect written words (handwriting) in 3 minutes (higher scores mean a worse outcome)
Time Frame
9 weeks
Title
Written skills without assistive technology after training
Description
Number of correct written words (handwriting) in 3 minutes (higher scores mean a better outcome) Number of incorrect written words (handwriting) in 3 minutes (higher scores mean a worse outcome)
Time Frame
9 weeks
Title
Written skills with assistive technology before training
Description
Number of correct written words in 3 minutes (higher scores mean a better outcome) Number of incorrect written words in 3 minutes (higher scores mean a worse outcome)
Time Frame
9 weeks
Title
Written skills with assistive technology after training
Description
Number of correct written words in 3 minutes (higher scores mean a better outcome) Number of incorrect written words in 3 minutes (higher scores mean a worse outcome)
Time Frame
9 weeks
Secondary Outcome Measure Information:
Title
Autonomy before training
Description
Autonomy in the daily life (number of help's need) (higher scores mean a worse outcome)
Time Frame
9 weeks
Title
Autonomy after training
Description
Autonomy in the daily life (number of help's need) (higher scores mean a worse outcome)
Time Frame
9 weeks
Title
Effectiveness of assistive technology utilization before training: Frequency of use
Description
(minutes per week) (higher scores mean a better outcome)
Time Frame
9 weeks
Title
Effectiveness of assistive technology utilization before training: Number of different utilization locations
Description
(home, school, …) (higher scores mean a better outcome)
Time Frame
9 weeks
Title
Effectiveness of assistive technology utilization before training: Number of different accomplished tasks
Description
(games, homework, messaging, social networks, …) (higher scores mean a better outcome)
Time Frame
9 weeks
Title
Effectiveness of assistive technology utilization after training: Frequency of use
Description
(minutes per week) (higher scores mean a better outcome)
Time Frame
9 weeks
Title
Effectiveness of assistive technology utilization after training: Number of different utilization locations
Description
(home, school, …) (higher scores mean a better outcome)
Time Frame
9 weeks
Title
Effectiveness of assistive technology utilization after training: Number of different accomplished tasks
Description
(games, homework, messaging, social networks, …) (higher scores mean a better outcome)
Time Frame
9 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adolescents with dyslexia normal schooling (not in a specialized establishment) with attribution of assistive technology less than 3 months or planned soon or low usage Exclusion Criteria: oral disabilities hindering intelligibility physical disabilities (hands) hindering use of AT auditive and visual disabilities
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hélène Desmaisons, MRS
Phone
+33231065905
Email
desmaisons-h@chu-caen.fr
First Name & Middle Initial & Last Name or Official Title & Degree
François Fournel, MR
Phone
+33231065781
Email
fournel-f@chu-caen.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hélène Desmaisons, MRS
Organizational Affiliation
University Hospital of Caen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Desmaisons
City
Caen
ZIP/Postal Code
14000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hélène Desmaisons, MRS
Phone
+3321065905
Email
desmaisons-h@chu-caen.fr
First Name & Middle Initial & Last Name & Degree
François Fournel, Mr
Phone
+33231065781
Email
fournel-f@chu-caen.fr

12. IPD Sharing Statement

Learn more about this trial

Usefulness of an Assistive Technology Training Program for Adolscents With Dyslexia

We'll reach out to this number within 24 hrs