NCT06937255

Brief 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 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 3, 2023

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2024

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

April 22, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

May 4, 2025

Status Verified

April 1, 2025

Enrollment Period

2.7 years

First QC Date

March 21, 2024

Last Update Submit

April 30, 2025

Conditions

Keywords

Developmental DyslexiaDevelopmental Language DisorderDynamic Assessmentcomputerized assessmentmultilingual populationchildren

Outcome Measures

Primary Outcomes (2)

  • accuracy during task performance

    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

    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)

Study Arms (8)

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.

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.

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.

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.

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.

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.

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.

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.

Diagnostic Test: computerized Dynamic Assessment

Interventions

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.

Also known as: MuLiMi Dynamic Assessment tools
DLD preschooler, monolingualDLD preschooler, multilingualSRD school-age, monolingualSRD school-age, multilingualTD preschooler, monolingualTD preschooler, multilingualTD school-age, monolingualTD school-age, multilingual

Eligibility Criteria

Age4 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Intellectual disability, major psychopathological disorders, exposure to Italian language for less than two years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS E. Medea, polo di Bosisio Parini

Bosisio Parini, LC, 23842, Italy

RECRUITING

Related Publications (3)

  • 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.

    PMID: 35429340BACKGROUND
  • 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.

    PMID: 31194570BACKGROUND
  • 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.

    PMID: 35230888BACKGROUND

MeSH Terms

Conditions

DyslexiaLanguage Development Disorders

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSpecific Learning DisorderLearning DisabilitiesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Officials

  • Maria Luisa Lorusso, Ph.D

    IRCCS E. Medea

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Luisa Lorusso, Ph.D

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2024

First Posted

April 22, 2025

Study Start

April 3, 2023

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

May 4, 2025

Record last verified: 2025-04

Locations