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Dynamiczna ocena ryzyka dla zaburzeń językowych i czytania u dzieci jednojęzycznych i wielojęzycznych

3 listopada 2026 zaktualizowane przez: IRCCS Eugenio Medea

Walidacja skomputeryzowanych zadań oceny dynamicznej w celu zidentyfikowania ryzyka zaburzeń języka rozwojowego (DLD) i konkretnego zaburzenia czytania (SRD) u dzieci jednojęzycznych i wielojęzycznych

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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

150

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

4 lata do 9 lat (Dziecko)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Ekranizacja
  • Przydział: Nielosowe
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: 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.
Test diagnostyczny: computerized Dynamic Assessment

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.

Inne nazwy:
  • Narzędzia do oceny dynamicznej Mulimi
Aktywny komparator: 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.
Test diagnostyczny: computerized Dynamic Assessment

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.

Inne nazwy:
  • Narzędzia do oceny dynamicznej Mulimi
Eksperymentalny: 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.
Test diagnostyczny: computerized Dynamic Assessment

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.

Inne nazwy:
  • Narzędzia do oceny dynamicznej Mulimi
Eksperymentalny: 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.
Test diagnostyczny: computerized Dynamic Assessment

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.

Inne nazwy:
  • Narzędzia do oceny dynamicznej Mulimi
Aktywny komparator: 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.
Test diagnostyczny: computerized Dynamic Assessment

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.

Inne nazwy:
  • Narzędzia do oceny dynamicznej Mulimi
Aktywny komparator: 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.
Test diagnostyczny: computerized Dynamic Assessment

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.

Inne nazwy:
  • Narzędzia do oceny dynamicznej Mulimi
Eksperymentalny: 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.
Test diagnostyczny: computerized Dynamic Assessment

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.

Inne nazwy:
  • Narzędzia do oceny dynamicznej Mulimi
Eksperymentalny: 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.
Test diagnostyczny: computerized Dynamic Assessment

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.

Inne nazwy:
  • Narzędzia do oceny dynamicznej Mulimi

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
accuracy during task performance
Ramy czasowe: day 1 and day 2 (one or two consecutive sessions depending on participant's age, collaboration and fatigue)

total number and % correct answers, number and % errors during task performance
day 1 and day 2 (one or two consecutive sessions depending on participant's age, collaboration and fatigue)
efficiency during task performance
Ramy czasowe: day 1 and day 2 (during assessment, which will last one or two days, in 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
day 1 and day 2 (during assessment, which will last one or two days, in one or two consecutive sessions depending on participant's age, collaboration and fatigue)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

IRCCS Eugenio Medea

Śledczy

  • Główny śledczy: Maria Luisa Lorusso, Ph.D, IRCCS E. Medea

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

3 kwietnia 2023

Zakończenie podstawowe (Szacowany)

1 grudnia 2028

Ukończenie studiów (Szacowany)

1 grudnia 2028

Daty rejestracji na studia

Pierwszy przesłany

21 marca 2024

Pierwszy przesłany, który spełnia kryteria kontroli jakości

17 kwietnia 2025

Pierwszy wysłany (Rzeczywisty)

22 kwietnia 2025

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

5 listopada 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

3 listopada 2026

Ostatnia weryfikacja

1 kwietnia 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 1036

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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