Developmental DyslexiaNCT06937255
Dynamic Assessment of the Risk for Language and Reading Disorders in Monolingual and Multilingual Children
A study testing computerized Dynamic Assessment in people with Developmental Dyslexia and Developmental Language Disorder, run by IRCCS Eugenio Medea at 1 site in Italy.
Trial summary
The project represents the completion of a part of the recently concluded European project MultiMind, in which a computer platform called MuLiMi was developed and validated. The platform hosts screening tests for the identification of the risk of Language and Learning Disorders in preschool and primary school… Read more about this study
- Who is it for?
- Ages 4 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Developmental Dyslexia, Developmental Language Disorder
- What is being tested?
- computerized Dynamic Assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 3 Apr 2023to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 4 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- age 4-6 years (Kindergarten) or 7-9 years (Primary school);
- Attendance at an Italian-language school in Italy or Switzerland/Germany.
- Additional inclusion criteria for the multilingual group only:
- (i) At least one parent speaks at least one language other than Italian in the family;
- (ii) Continuous exposure to the Italian language for at least two years.
Who cannot join
- Intellectual disability, major psychopathological disorders, exposure to Italian language for less than two years.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS E. Medea, polo di Bosisio Parini
Bosisio Parini, LC, 23842
Maria Luisa Lorusso, Ph.D, 031-877592, marialuisa.lorusso@lanostrafamiglia.it
About this study
Official title: Validation of Computerized Dynamic Assessment Tasks to Identify the Risk of Developmental Language Disorders (DLD) and Specific Reading Disorder (SRD) in Monolingual and Multilingual Children
The project represents the completion of a part of the recently concluded European project MultiMind, in which a computer platform called MuLiMi was developed and validated. The platform hosts screening tests for the identification of the risk of Language and Learning Disorders in preschool and primary school children, respectively. The aim is to validate the Dynamic Assessment (DA) tests (a first test assessing the capacity to learn new words for preschool children and a second one assessing the capacity to learn a new spelling code for school-age children) in a population of monolingual and bilingual children attending preschool and primary school. The main goal of the study is to complete the validation of the two Dynamic Assessment tests implemented in the MuLiMi platform developed for the MultiMind project.
Read the detailed description
Dynamic Assessment tests are characterized by their emphasis on the learning process activated during the test itself, focusing on measuring the improvement achieved from the beginning to the end of the test rather than the absolute level of performance. They are thus considered measures of the learning potential (in this case, language and spelling) of the assessed subject. This type of testing is used as an integration of static assessment (traditional, aimed at detecting absolute performance level) and has proven particularly useful in the assessment of multilingual children.
However, computerized tests that can also be used remotely are not currently available. For these reasons, it was found particularly useful to include this type of task within the MuLiMi computerized battery. While the other tests hosted on the MuLiMi platform concern specific L1-L2 pairs, DA tests can be applied regardless of the L1 (provided a minimum L2 mastery is present so as to understand the requests) because they assess the capacity to learn new information and are thus rather independent of previous knowledge. This study will provide baseline data for the MuLiMi battery applied to children belonging to any language minority group and thus enable it to be used comprehensively in the future for the purpose of risk assessment of language and learning disorders.
- Being tested
- computerized Dynamic Assessment
- Keywords
- Developmental Dyslexia, Developmental Language Disorder, Dynamic Assessment, computerized assessment, multilingual population, children
- Medical subject headings
- Dyslexia, Language Development Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computerized Dynamic AssessmentDiagnostic test
Also called MuLiMi Dynamic Assessment tools
The DA tests (with a duration of about 30 minutes) can be administered by accessing the digital platform MuLiMi, individually with the experimenter or examiner. The tests are in game form and require children to learn the names of characters presented in the context of stories (preschool version) or to learn new codes for reading and writing (primary school version). In both cases, the new materials (names or codes) are repeatedly presented to the child until (s)he reaches an accuracy threshold. The number of repetitions needed to reach the threshold constitutes the main measure of the child's learning capacity, together with the number of errors committed during the various cycles.
| Study group | Role | What they receive |
|---|---|---|
| TD preschooler, monolingual | Active comparator | This group will include monolingual children who have not been referred to clinical or educational services for any delay or disorder in language abilities. They will be tested with the MuLiMi battery (lexical, phonological and morphosyntactic tests), including the DA Novel Word Learning Test (NWLT) as DA screening test. Furthermore, they will be assessed with standardized language tests providing benchmark measures for validation. Receives: Diagnostic Test: computerized Dynamic Assessment |
| TD preschooler, multilingual | Active comparator | This group will include multilingual children who have not been referred to clinical or educational services for any delay or disorder in language abilities. They will be tested with the MuLiMi battery (lexical, phonological and morphosyntactic tests), including the DA Novel Word Learning Test (NWLT) as DA screening test. Furthermore, they will be assessed with standardized language tests providing benchmark measures for validation. Receives: Diagnostic Test: computerized Dynamic Assessment |
| DLD preschooler, monolingual | Experimental | This group will include monolingual children who have been referred to clinical or educational services because of delays or disorders in language abilities. They will be tested with the MuLiMi battery (lexical, phonological and morphosyntactic tests), including the DA Novel Word Learning Test (NWLT) as DA screening test. Furthermore, they will be assessed with standardized language tests providing benchmark measures for validation. Receives: Diagnostic Test: computerized Dynamic Assessment |
| DLD preschooler, multilingual | Experimental | This group will include multilingual children who have been referred to clinical or educational services because of delays or disorders in language abilities. They will be tested with the MuLiMi battery (lexical, phonological and morphosyntactic tests), including the DA Novel Word Learning Test (NWLT) as DA screening test. Furthermore, they will be assessed with standardized language tests providing benchmark measures for validation. Receives: Diagnostic Test: computerized Dynamic Assessment |
| TD school-age, monolingual | Active comparator | This group will include monolingual children who have not been referred to clinical or educational services for any delay or disorder in language abilities. They will be tested with the MuLiMi battery (reading, orthographic and metaphonological tests), including the Dynamic Reading Assessment (DRA) as DA screening test. Furthermore, they will be assessed with standardized reading and language tests providing benchmark measures for validation. Receives: Diagnostic Test: computerized Dynamic Assessment |
| TD school-age, multilingual | Active comparator | This group will include monolingual children who have not been referred to clinical or educational services for any delay or disorder in language abilities. They will be tested with the MuLiMi battery (reading, orthographic and metaphonological tests), including the Dynamic Reading Assessment (DRA) as DA screening test. Furthermore, they will be assessed with standardized reading and language tests providing benchmark measures for validation. Receives: Diagnostic Test: computerized Dynamic Assessment |
| SRD school-age, monolingual | Experimental | This group will include monolingual children who have been referred to clinical or educational services for any delay or disorder in language abilities. They will be tested with the MuLiMi battery (reading, orthographic and metaphonological tests), including the Dynamic Reading Assessment (DRA) as DA screening test. Furthermore, they will be assessed with standardized reading and language tests providing benchmark measures for validation. Receives: Diagnostic Test: computerized Dynamic Assessment |
| SRD school-age, multilingual | Experimental | This group will include multilingual children who have been referred to clinical or educational services for any delay or disorder in language abilities. They will be tested with the MuLiMi battery (reading, orthographic and metaphonological tests), including the Dynamic Reading Assessment (DRA) as DA screening test. Furthermore, they will be assessed with standardized reading and language tests providing benchmark measures for validation. Receives: Diagnostic Test: computerized Dynamic Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy during task performance
total number and % correct answers, number and % errors during task performance
Measured: one or two days (one or two consecutive sessions depending on participant's age, collaboration and fatigue)
efficiency during task performance
number of repeated cycles, number of cycles needed to reach target performance
Measured: Intervention occurs during assessment: assessment will last one or two days (one or two consecutive sessions depending on participant's age, collaboration and fatigue)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start3 Apr 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Developmental DyslexiaStudies of the same condition, open and under way.
- 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study will compare performance in a parallel manner in two populations: preschool and school-age children. Preschool age children will be assessed with the DA screening test for the risk of DLD, whereas school-age children will be assessed with the DA screening test for the risk of SRD. Each of the two groups will be subdivided into 2 groups: typically developing (TD) and atypically developing (AD). Each of the 2 groups will be further subdivided into monolingual and multilingual children. Pairwise comparisons will be performed to assess the capacity of the DA screening tools to discriminate AD from TD children, separately for monolingual and multilingual children.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Eugenio Medea
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Luisa Lorusso, Ph.D, Principal investigator, IRCCS E. Medea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06937255
- Sponsor's protocol ID
- 1036
- Status last verified
- Apr 2025
- First submitted
- 21 Mar 2024
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
MacLeod AAN, Glaspey AM. Dynamic assessment of multilingual children's word learning. Int J Lang Commun Disord. 2022 Jul;57(4):822-851. doi: 10.1111/1460-6984.12723. Epub 2022 Apr 16.
PubMed 35429340Orellana CI, Wada R, Gillam RB. The Use of Dynamic Assessment for the Diagnosis of Language Disorders in Bilingual Children: A Meta-Analysis. Am J Speech Lang Pathol. 2019 Aug 9;28(3):1298-1317. doi: 10.1044/2019_AJSLP-18-0202. Epub 2019 Jun 13.
PubMed 31194570Hunt E, Nang C, Meldrum S, Armstrong E. Can Dynamic Assessment Identify Language Disorder in Multilingual Children? Clinical Applications From a Systematic Review. Lang Speech Hear Serv Sch. 2022 Apr 11;53(2):598-625. doi: 10.1044/2021_LSHSS-21-00094. Epub 2022 Mar 1.
PubMed 35230888
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Computerized Dynamic Assessment Tasks to Identify the Risk of Developmental Language Disorders (DLD) and Specific Reading Disorder (SRD) in Monolingual and Multilingual Children
- ClinicalTrials.gov ID
- NCT06937255
- Acronym / sponsor ID
- 1036
- Keywords
- Developmental Dyslexia, Developmental Language Disorder, Dynamic Assessment, computerized assessment, multilingual population, children
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- IRCCS Eugenio MedeaUniversity, hospital or other
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 22 Apr 2025 (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.
The project represents the completion of a part of the recently concluded European project MultiMind, in which a computer platform called MuLiMi was developed and validated. The platform hosts screening tests for the identification of the risk of Language and Learning Disorders in preschool and primary school children, respectively. The aim is to validate the Dynamic Assessment (DA) tests (a first test assessing the capacity to learn new words for preschool children and a second one assessing the capacity to learn a new spelling code for school-age children) in a population of monolingual and bilingual children attending preschool and primary school. The main goal of the study is to complete the validation of the two Dynamic Assessment tests implemented in the MuLiMi platform developed for the MultiMind project.
Detailed description
Dynamic Assessment tests are characterized by their emphasis on the learning process activated during the test itself, focusing on measuring the improvement achieved from the beginning to the end of the test rather than the absolute level of performance. They are thus considered measures of the learning potential (in this case, language and spelling) of the assessed subject. This type of testing is used as an integration of static assessment (traditional, aimed at detecting absolute performance level) and has proven particularly useful in the assessment of multilingual children.
However, computerized tests that can also be used remotely are not currently available. For these reasons, it was found particularly useful to include this type of task within the MuLiMi computerized battery. While the other tests hosted on the MuLiMi platform concern specific L1-L2 pairs, DA tests can be applied regardless of the L1 (provided a minimum L2 mastery is present so as to understand the requests) because they assess the capacity to learn new information and are thus rather independent of previous knowledge. This study will provide baseline data for the MuLiMi battery applied to children belonging to any language minority group and thus enable it to be used comprehensively in the future for the purpose of risk assessment of language and learning disorders.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
- Model description
- The study will compare performance in a parallel manner in two populations: preschool and school-age children. Preschool age children will be assessed with the DA screening test for the risk of DLD, whereas school-age children will be assessed with the DA screening test for the risk of SRD. Each of the two groups will be subdivided into 2 groups: typically developing (TD) and atypically developing (AD). Each of the 2 groups will be further subdivided into monolingual and multilingual children. Pairwise comparisons will be performed to assess the capacity of the DA screening tools to discriminate AD from TD children, separately for monolingual and multilingual children.
| Arm | Type | Receives |
|---|---|---|
| TD preschooler, monolingual | Active comparator | Diagnostic Test: computerized Dynamic AssessmentThis group will include monolingual children who have not been referred to clinical or educational services for any delay or disorder in language abilities. They will be tested with the MuLiMi battery (lexical, phonological and morphosyntactic tests), including the DA Novel Word Learning Test (NWLT) as DA screening test. Furthermore, they will be assessed with standardized language tests providing benchmark measures for validation. |
| TD preschooler, multilingual | Active comparator | Diagnostic Test: computerized Dynamic AssessmentThis group will include multilingual children who have not been referred to clinical or educational services for any delay or disorder in language abilities. They will be tested with the MuLiMi battery (lexical, phonological and morphosyntactic tests), including the DA Novel Word Learning Test (NWLT) as DA screening test. Furthermore, they will be assessed with standardized language tests providing benchmark measures for validation. |
| DLD preschooler, monolingual | Experimental | Diagnostic Test: computerized Dynamic AssessmentThis group will include monolingual children who have been referred to clinical or educational services because of delays or disorders in language abilities. They will be tested with the MuLiMi battery (lexical, phonological and morphosyntactic tests), including the DA Novel Word Learning Test (NWLT) as DA screening test. Furthermore, they will be assessed with standardized language tests providing benchmark measures for validation. |
| DLD preschooler, multilingual | Experimental | Diagnostic Test: computerized Dynamic AssessmentThis group will include multilingual children who have been referred to clinical or educational services because of delays or disorders in language abilities. They will be tested with the MuLiMi battery (lexical, phonological and morphosyntactic tests), including the DA Novel Word Learning Test (NWLT) as DA screening test. Furthermore, they will be assessed with standardized language tests providing benchmark measures for validation. |
| TD school-age, monolingual | Active comparator | Diagnostic Test: computerized Dynamic AssessmentThis group will include monolingual children who have not been referred to clinical or educational services for any delay or disorder in language abilities. They will be tested with the MuLiMi battery (reading, orthographic and metaphonological tests), including the Dynamic Reading Assessment (DRA) as DA screening test. Furthermore, they will be assessed with standardized reading and language tests providing benchmark measures for validation. |
| TD school-age, multilingual | Active comparator | Diagnostic Test: computerized Dynamic AssessmentThis group will include monolingual children who have not been referred to clinical or educational services for any delay or disorder in language abilities. They will be tested with the MuLiMi battery (reading, orthographic and metaphonological tests), including the Dynamic Reading Assessment (DRA) as DA screening test. Furthermore, they will be assessed with standardized reading and language tests providing benchmark measures for validation. |
| SRD school-age, monolingual | Experimental | Diagnostic Test: computerized Dynamic AssessmentThis group will include monolingual children who have been referred to clinical or educational services for any delay or disorder in language abilities. They will be tested with the MuLiMi battery (reading, orthographic and metaphonological tests), including the Dynamic Reading Assessment (DRA) as DA screening test. Furthermore, they will be assessed with standardized reading and language tests providing benchmark measures for validation. |
| SRD school-age, multilingual | Experimental | Diagnostic Test: computerized Dynamic AssessmentThis group will include multilingual children who have been referred to clinical or educational services for any delay or disorder in language abilities. They will be tested with the MuLiMi battery (reading, orthographic and metaphonological tests), including the Dynamic Reading Assessment (DRA) as DA screening test. Furthermore, they will be assessed with standardized reading and language tests providing benchmark measures for validation. |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- age 4-6 years (Kindergarten) or 7-9 years (Primary school);
- Attendance at an Italian-language school in Italy or Switzerland/Germany.
- (i) At least one parent speaks at least one language other than Italian in the family;
- (ii) Continuous exposure to the Italian language for at least two years.
Key exclusion criteria (1 listed)
- Intellectual disability, major psychopathological disorders, exposure to Italian language for less than two years.
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 |
|---|---|---|
| computerized Dynamic AssessmentAlso: MuLiMi Dynamic Assessment toolsThe DA tests (with a duration of about 30 minutes) can be administered by accessing the digital platform MuLiMi, individually with the experimenter or examiner. The tests are in game form and require children to learn the names of characters presented in the context of stories (preschool version) or to learn new codes for reading and writing (primary school version). In both cases, the new materials (names or codes) are repeatedly presented to the child until (s)he reaches an accuracy threshold. The number of repetitions needed to reach the threshold constitutes the main measure of the child's learning capacity, together with the number of errors committed during the various cycles. | Diagnostic test | DLD preschooler, monolingual, DLD preschooler, multilingual, SRD school-age, monolingual, SRD school-age, multilingual, TD preschooler, monolingual, TD preschooler, multilingual, TD school-age, monolingual, TD school-age, multilingual |
Primary outcome
accuracy during task performance
Time frame: one or two days (one or two consecutive sessions depending on participant's age, collaboration and fatigue)
total number and % correct answers, number and % errors during task performance
efficiency during task performance
Time frame: Intervention occurs during assessment: assessment will last one or two days (one or two consecutive sessions depending on participant's age, collaboration and fatigue)
number of repeated cycles, number of cycles needed to reach target performance
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- Background: PubMed 35429340MacLeod AAN, Glaspey AM. Dynamic assessment of multilingual children's word learning. Int J Lang Commun Disord. 2022 Jul;57(4):822-851. doi: 10.1111/1460-6984.12723. Epub 2022 Apr 16.
- Background: PubMed 31194570Orellana CI, Wada R, Gillam RB. The Use of Dynamic Assessment for the Diagnosis of Language Disorders in Bilingual Children: A Meta-Analysis. Am J Speech Lang Pathol. 2019 Aug 9;28(3):1298-1317. doi: 10.1044/2019_AJSLP-18-0202. Epub 2019 Jun 13.
- Background: PubMed 35230888Hunt E, Nang C, Meldrum S, Armstrong E. Can Dynamic Assessment Identify Language Disorder in Multilingual Children? Clinical Applications From a Systematic Review. Lang Speech Hear Serv Sch. 2022 Apr 11;53(2):598-625. doi: 10.1044/2021_LSHSS-21-00094. Epub 2022 Mar 1.
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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.
Maria Luisa Lorusso, Ph.D principal investigator
IRCCS E. Medea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing computerized Dynamic Assessment in people with Developmental Dyslexia and Developmental Language Disorder, run by IRCCS Eugenio Medea at 1 site in Italy.
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 5 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 4 May 2025. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Luisa Lorusso, Ph.D (031-877592, marialuisa.lorusso@lanostrafamiglia.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
accuracy during task performance (time frame: one or two days (one or two consecutive sessions depending on participant's age, collaboration and fatigue)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06937255, which also lists 3 linked publications.
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 4 May 2025.