DyslexiaFormONCNCT05636813
Usefulness of an Assistive Technology Training Program for Adolscents With Dyslexia
A study testing Training in people with Dyslexia and Adolescent, run by University Hospital, Caen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 15 years
- Conditions the study is for
- Dyslexia, Adolescent
- What is being tested?
- Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 8 Mar 2021to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- oral disabilities hindering intelligibility
- physical disabilities (hands) hindering use of AT
- auditive and visual disabilities
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Desmaisons
Caen, 14000
Hélène Desmaisons, MRS, +3321065905, desmaisons-h@chu-caen.fr
François Fournel, Mr, +33231065781, fournel-f@chu-caen.fr
About this study
Official title: Usefulness of an Assistive Technology Training Program for Adolescents With Dyslexia: Pilot Study
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.
Read more
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.
- Conditions
- Dyslexia, Adolescent
- Being tested
- Training
- Keywords
- dyslexic adolescent, dyslexia, education, assistive technology
- Medical subject headings
- Dyslexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrainingOther
Patients are trained to use AT (2 sessions of 4 hours). Written langage skills, autonomy, the use are evaluated before and after training.
| Study group | Role | What they receive |
|---|---|---|
| Training | Experimental | Program of training of use of assistive technology Receives: Other: Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reading skills without assistive technology before training: number of words read
minimum 0 and maximum 152, higher scores mean a better outcome
Measured: 9 weeks
Reading skills without assistive technology before training: number of misread
minimum 0 and maximum 152, higher scores mean a worse outcome
Measured: 9 weeks
Reading skills without assistive technology before training: time to read
(in seconds, higher times mean a worse outcome)
Measured: 9 weeks
Reading comprehension skills without assistive technology before training: titles choices
(higher scores mean a better outcome, minimum 0 and maximum 6)
Measured: 9 weeks
Reading comprehension skills without assistive technology before training: right or wrong
(higher scores mean a better outcome: minimum 0 and maximum 8)
Measured: 9 weeks
Reading comprehension skills without assistive technology before training: choice of the good answer
(higher scores mean a better outcome:minimum 0 and maximum 4).
Measured: 9 weeks
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)
Measured: 9 weeks
Reading skills without assistive technology after training: number of words read
(minimum 0 and maximum 152, higher scores mean a better outcome)
Measured: 9 weeks
Reading skills without assistive technology after training: number of misread
(minimum 0 and maximum 152, higher scores mean a worse outcome)
Measured: 9 weeks
Reading skills without assistive technology after training: time to read
(in seconds, higher times mean a worse outcome)
Measured: 9 weeks
Reading comprehension skills without assistive technology after training: titles choices
(higher scores mean a better outcome, minimum 0 and maximum 6)
Measured: 9 weeks
Reading comprehension skills without assistive technology after training: right or wrong
(higher scores mean a better outcome: minimum 0 and maximum 8)
Measured: 9 weeks
Reading comprehension skills without assistive technology after training: choice of the good answer
(higher scores mean a better outcome:minimum 0 and maximum 4).
Measured: 9 weeks
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)
Measured: 9 weeks
Reading skills with assistive technology before training: number of words read
(minimum 0 and maximum 152, higher scores mean a better outcome)
Measured: 9 weeks
Reading skills with assistive technology before training: number of misread
(minimum 0 and maximum 152, higher scores mean a worse outcome)
Measured: 9 weeks
Reading skills with assistive technology before training: time to read
(in seconds, higher times mean a worse outcome)
Measured: 9 weeks
Reading comprehension skills with assistive technology before training: titles choices
(higher scores mean a better outcome, minimum 0 and maximum 6)
Measured: 9 weeks
Reading comprehension skills with assistive technology before training: right or wrong
(higher scores mean a better outcome: minimum 0 and maximum 8)
Measured: 9 weeks
Reading comprehension skills with assistive technology before training: choice of the good answer
(higher scores mean a better outcome:minimum 0 and maximum 4).
Measured: 9 weeks
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)
Measured: 9 weeks
Reading skills with assistive technology after training: number of words read
(minimum 0 and maximum 152, higher scores mean a better outcome)
Measured: 9 weeks
Reading skills with assistive technology after training: number of misread
(minimum 0 and maximum 152, higher scores mean a worse outcome)
Measured: 9 weeks
Reading skills with assistive technology after training: time to read
(in seconds, higher times mean a worse outcome)
Measured: 9 weeks
Reading comprehension skills with assistive technology after training: titles choices
(higher scores mean a better outcome, minimum 0 and maximum 6)
Measured: 9 weeks
Reading comprehension skills with assistive technology after training: right or wrong
(higher scores mean a better outcome: minimum 0 and maximum 8)
Measured: 9 weeks
Reading comprehension skills with assistive technology after training: choice of the good answer
(higher scores mean a better outcome:minimum 0 and maximum 4).
Measured: 9 weeks
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)
Measured: 9 weeks
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)
Measured: 9 weeks
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)
Measured: 9 weeks
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)
Measured: 9 weeks
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)
Measured: 9 weeks
Secondary outcomes (8)
Autonomy before training
Autonomy in the daily life (number of help's need) (higher scores mean a worse outcome)
Measured: 9 weeks
Autonomy after training
Autonomy in the daily life (number of help's need) (higher scores mean a worse outcome)
Measured: 9 weeks
Effectiveness of assistive technology utilization before training: Frequency of use
(minutes per week) (higher scores mean a better outcome)
Measured: 9 weeks
Effectiveness of assistive technology utilization before training: Number of different utilization locations
(home, school, …) (higher scores mean a better outcome)
Measured: 9 weeks
Effectiveness of assistive technology utilization before training: Number of different accomplished tasks
(games, homework, messaging, social networks, …) (higher scores mean a better outcome)
Measured: 9 weeks
Effectiveness of assistive technology utilization after training: Frequency of use
(minutes per week) (higher scores mean a better outcome)
Measured: 9 weeks
Effectiveness of assistive technology utilization after training: Number of different utilization locations
(home, school, …) (higher scores mean a better outcome)
Measured: 9 weeks
Effectiveness of assistive technology utilization after training: Number of different accomplished tasks
(games, homework, messaging, social networks, …) (higher scores mean a better outcome)
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start8 Mar 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslexiaStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot, pronostic, open-label, non-randomized, descriptive, study
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hélène Desmaisons, MRS, Principal investigator, University Hospital of Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05636813
- Sponsor's protocol ID
- 20-160
- Acronym
- FormONC
- Status last verified
- Feb 2022
- First submitted
- 19 Apr 2021
- Last updated
- 5 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of an Assistive Technology Training Program for Adolescents With Dyslexia: Pilot Study
- ClinicalTrials.gov ID
- NCT05636813
- Acronym / sponsor ID
- FormONC / 20-160
- Conditions
- Dyslexia, Adolescent
- Keywords
- dyslexic adolescent, dyslexia, education, assistive technology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 5 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot, pronostic, open-label, non-randomized, descriptive, study
| Arm | Type | Receives |
|---|---|---|
| Training | Experimental | Other: TrainingProgram of training of use of assistive technology |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- oral disabilities hindering intelligibility
- physical disabilities (hands) hindering use of AT
- auditive and visual disabilities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TrainingPatients are trained to use AT (2 sessions of 4 hours). Written langage skills, autonomy, the use are evaluated before and after training. | Other | Training |
Primary outcome
Reading skills without assistive technology before training: number of words read
Time frame: 9 weeks
minimum 0 and maximum 152, higher scores mean a better outcome
Reading skills without assistive technology before training: number of misread
Time frame: 9 weeks
minimum 0 and maximum 152, higher scores mean a worse outcome
Reading skills without assistive technology before training: time to read
Time frame: 9 weeks
(in seconds, higher times mean a worse outcome)
Reading comprehension skills without assistive technology before training: titles choices
Time frame: 9 weeks
(higher scores mean a better outcome, minimum 0 and maximum 6)
Reading comprehension skills without assistive technology before training: right or wrong
Time frame: 9 weeks
(higher scores mean a better outcome: minimum 0 and maximum 8)
Reading comprehension skills without assistive technology before training: choice of the good answer
Time frame: 9 weeks
(higher scores mean a better outcome:minimum 0 and maximum 4).
Reading effectiveness without assistive technology before training
Time frame: 9 weeks
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
Time frame: 9 weeks
(minimum 0 and maximum 152, higher scores mean a better outcome)
Reading skills without assistive technology after training: number of misread
Time frame: 9 weeks
(minimum 0 and maximum 152, higher scores mean a worse outcome)
Reading skills without assistive technology after training: time to read
Time frame: 9 weeks
(in seconds, higher times mean a worse outcome)
Reading comprehension skills without assistive technology after training: titles choices
Time frame: 9 weeks
(higher scores mean a better outcome, minimum 0 and maximum 6)
Reading comprehension skills without assistive technology after training: right or wrong
Time frame: 9 weeks
(higher scores mean a better outcome: minimum 0 and maximum 8)
Reading comprehension skills without assistive technology after training: choice of the good answer
Time frame: 9 weeks
(higher scores mean a better outcome:minimum 0 and maximum 4).
Reading effectiveness without assistive technology after training
Time frame: 9 weeks
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
Time frame: 9 weeks
(minimum 0 and maximum 152, higher scores mean a better outcome)
Reading skills with assistive technology before training: number of misread
Time frame: 9 weeks
(minimum 0 and maximum 152, higher scores mean a worse outcome)
Reading skills with assistive technology before training: time to read
Time frame: 9 weeks
(in seconds, higher times mean a worse outcome)
Reading comprehension skills with assistive technology before training: titles choices
Time frame: 9 weeks
(higher scores mean a better outcome, minimum 0 and maximum 6)
Reading comprehension skills with assistive technology before training: right or wrong
Time frame: 9 weeks
(higher scores mean a better outcome: minimum 0 and maximum 8)
Reading comprehension skills with assistive technology before training: choice of the good answer
Time frame: 9 weeks
(higher scores mean a better outcome:minimum 0 and maximum 4).
Reading effectiveness with assistive technology before training
Time frame: 9 weeks
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
Time frame: 9 weeks
(minimum 0 and maximum 152, higher scores mean a better outcome)
Reading skills with assistive technology after training: number of misread
Time frame: 9 weeks
(minimum 0 and maximum 152, higher scores mean a worse outcome)
Reading skills with assistive technology after training: time to read
Time frame: 9 weeks
(in seconds, higher times mean a worse outcome)
Reading comprehension skills with assistive technology after training: titles choices
Time frame: 9 weeks
(higher scores mean a better outcome, minimum 0 and maximum 6)
Reading comprehension skills with assistive technology after training: right or wrong
Time frame: 9 weeks
(higher scores mean a better outcome: minimum 0 and maximum 8)
Reading comprehension skills with assistive technology after training: choice of the good answer
Time frame: 9 weeks
(higher scores mean a better outcome:minimum 0 and maximum 4).
Reading effectiveness with assistive technology after training
Time frame: 9 weeks
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
Time frame: 9 weeks
* 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
Time frame: 9 weeks
* 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
Time frame: 9 weeks
* 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
Time frame: 9 weeks
* 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)
8 secondary outcomes
Autonomy before training
Time frame: 9 weeks
Autonomy after training
Time frame: 9 weeks
Effectiveness of assistive technology utilization before training: Frequency of use
Time frame: 9 weeks
Effectiveness of assistive technology utilization before training: Number of different utilization locations
Time frame: 9 weeks
Effectiveness of assistive technology utilization before training: Number of different accomplished tasks
Time frame: 9 weeks
Effectiveness of assistive technology utilization after training: Frequency of use
Time frame: 9 weeks
Effectiveness of assistive technology utilization after training: Number of different utilization locations
Time frame: 9 weeks
Effectiveness of assistive technology utilization after training: Number of different accomplished tasks
Time frame: 9 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2022.
Related trials for Dyslexia
Enrolling by invitation
Brain Stimulation Paired With Structured Reading Instruction in Children With Dyslexia
Dyslexia, Reading Disability
Recruiting
Personalization of Visual Characters and Text-to-Speech (TTS) to Support Learning in Students With Reading Difficulties
Developmental Dyslexia, Reading Problem
Recruiting
Dynamic Assessment of the Risk for Language and Reading Disorders in Monolingual and Multilingual Children
Developmental Dyslexia, Developmental Language Disorder
Active, not recruiting
Promoting Caregiver Implementation of an Effective Early Learning Intervention
Developmental Language Disorder, Reading; Difficult
Active, not recruiting
Pai.ACT: AI-Driven ACT Chatbot for Mental Health Triage and Service Evaluation
Autism Spectrum Disorder, Attention Deficit Disorder With Hyperactivity (ADHD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hélène Desmaisons, MRS principal investigator
University Hospital of Caen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training in people with Dyslexia and Adolescent, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hélène Desmaisons, MRS (+33231065905, desmaisons-h@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reading skills without assistive technology before training: number of words read (time frame: 9 weeks). The study lists 32 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2022.