- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06937255
Dynamic Assessment of the Risk for Language and Reading Disorders in Monolingual and Multilingual Children
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
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Maria Luisa Lorusso, Ph.D
- Phone Number: 031-877592
- Email: marialuisa.lorusso@lanostrafamiglia.it
Study Locations
-
-
LC
-
Bosisio Parini, LC, Italy, 23842
- Recruiting
- IRCCS E. Medea, polo di Bosisio Parini
-
Contact:
- Maria Luisa Lorusso, Ph.D
- Phone Number: 031-877592
- Email: marialuisa.lorusso@lanostrafamiglia.it
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Intellectual disability, major psychopathological disorders, exposure to Italian language for less than two years.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: TD preschooler, monolingual
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.
|
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.
Other Names:
|
|
Active Comparator: TD preschooler, multilingual
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.
|
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.
Other Names:
|
|
Experimental: DLD preschooler, monolingual
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.
|
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.
Other Names:
|
|
Experimental: DLD preschooler, multilingual
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.
|
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.
Other Names:
|
|
Active Comparator: TD school-age, monolingual
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.
|
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.
Other Names:
|
|
Active Comparator: TD school-age, multilingual
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.
|
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.
Other Names:
|
|
Experimental: SRD school-age, monolingual
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.
|
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.
Other Names:
|
|
Experimental: SRD school-age, multilingual
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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
one or two days (one or two consecutive sessions depending on participant's age, collaboration and fatigue)
|
|
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
|
Intervention occurs during assessment: assessment will last one or two days (one or two consecutive sessions depending on participant's age, collaboration and fatigue)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Maria Luisa Lorusso, Ph.D, IRCCS E. Medea
Publications and helpful links
General 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.
- Orellana 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.
- Hunt 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1036
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
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