- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT06937255
단일 언어 및 다국어 어린이의 언어 위험 및 읽기 장애에 대한 동적 평가
발달 언어 장애 (DLD)의 위험을 식별하기위한 전산화 된 동적 평가 작업의 검증 및 다국어 및 다국적 아동의 특정 판독 장애 (SRD)
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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Maria Luisa Lorusso, Ph.D
- 전화번호: 031-877592
- 이메일: marialuisa.lorusso@lanostrafamiglia.it
연구 장소
-
-
LC
-
Bosisio Parini, LC, 이탈리아, 23842
- 모병
- IRCCS E. Medea, polo di Bosisio Parini
-
연락하다:
- Maria Luisa Lorusso, Ph.D
- 전화번호: 031-877592
- 이메일: marialuisa.lorusso@lanostrafamiglia.it
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 상영
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: 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.
다른 이름들:
|
|
활성 비교기: 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.
다른 이름들:
|
|
실험적: 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.
다른 이름들:
|
|
실험적: 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.
다른 이름들:
|
|
활성 비교기: 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.
다른 이름들:
|
|
활성 비교기: 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.
다른 이름들:
|
|
실험적: 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.
다른 이름들:
|
|
실험적: 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.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
accuracy during task performance
기간: 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
기간: 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)
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Maria Luisa Lorusso, Ph.D, IRCCS E. Medea
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .