Clinical trial NCT06937255: Dynamic Assessment of the Risk for Language and Reading Disorders in Monolingual and Multilingual Children
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Developmental Dyslexia
Developmental Language Disorder
Keywords: Developmental Dyslexia
Developmental Language Disorder
Dynamic Assessment
computerized assessment
multilingual population
children
Lead sponsor: IRCCS Eugenio Medea
Sponsor class: OTHER
First posted: 2025-04-22
Enrollment: 150
Sex: ALL
Minimum age (years): 4
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SCREENING

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: accuracy during task performance
timeFrame: one or two days (one or two consecutive sessions depending on participant's age, collaboration and fatigue)
measure: efficiency during task performance
timeFrame: Intervention occurs during assessment: assessment will last one or two days (one or two consecutive sessions depending on participant's age, collaboration and fatigue)
Secondary outcomes:
Other outcomes:
Locations:
city: Bosisio Parini
country: Italy
facility: IRCCS E. Medea, polo di Bosisio Parini
state: LC
Study officials:
affiliation: IRCCS E. Medea
name: Maria Luisa Lorusso, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.