NCT06557382

Brief Summary

The aim of this study is to examine the relationship between cognitive skills, reading speed and reading comprehension skills in children who will learn to read and who do not have any diagnosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 2, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 9, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 16, 2024

Completed
Last Updated

August 16, 2024

Status Verified

August 1, 2024

Enrollment Period

2 months

First QC Date

August 9, 2024

Last Update Submit

August 13, 2024

Conditions

Keywords

cognitive skillspredict reading speedchild

Outcome Measures

Primary Outcomes (7)

  • Frankfurter tests

    The reliability and validity studies of the Frankfurter Concentration Test for five-year-old children, developed by Raatz and Möhling (1971). were conducted in Germany.It is a short, simple test that measures attention and concentration skills. It is a performance test that involves marking a target stimulus in a visual.

    Baseline and 6 months after initial evaluation

  • Cancellation Test

    It is a neuropsychological test developed by Weintraub and Mesulam (1985). The IT in the BILNOT Battery has been standardized for both adults and children. In studies conducted in our country, it has been observed that the IT scores are grouped under the factors of visual-spatial scanning, impulsivity and reaction speed regarding the stimulus context.

    Baseline and 6 months after initial evaluation

  • Executive Functions and Occupational Routines Scale (EFORTS)

    It evaluates the mental characteristics of children aged 6-12, such as impulse, verbal and non-verbal memory, self-regulation, problem solving, and planning. It is scored by the family on a 1-5 Likert scale. It has 3 subsections, including morning-evening routines, play-fun, and social routines, and contains a total of 30 questions.

    Baseline and 6 months after initial evaluation

  • Forward and Backward Digit Span

    To assess working memory, the Digit Span Subtest of the Wechsler Intelligence Scale for children was used ın forward digit span, the child is told a 2-digit number and asked to repeat it. When the same digit is repeated twice correctly, the number of digits is increased. The number of digits is increased until an error is made. When an error is made twice, the test is finished and the forward digit span is determined. The backward digit span is similar to the forward digit span. The only difference is that the child is asked to repeat the given numbers backwards.

    Baseline and 6 months after initial evaluation

  • The Head-Toes-Knees-Shoulders

    It measures children's ability to regulate their behavior. Children are asked to do the opposite of what is said. The task increases in complexity by including 4 body parts (head, toe, knee and shoulder). Answers are scored from 0 to 2 points.

    Baseline and 6 months after initial evaluation

  • Motor-free Perception Test (MVPT-3).

    MVPT-3 includes all visual perception subheadings. The test consists of 9 subfields and 65 shapes, namely visual discrimination (1-8), shape formation (9-13), visual memory-I (14-21), visual proximity-I(22-34), visual discrimination (35-45), position in space (46-50), figure-ground (51-55), visual proximity-II (56-60) and visual memory-II (61-65). Total visual perception score is calculated.

    Baseline and 6 months after initial evaluation

  • Test of Integrated Language and Literacy Skills (TILLS)

    It was developed by Nelson and his colleagues to assess the oral and written language skills of school-age children (6-18). The test consists of 15 subtests that measure different stages of oral and written language skills.

    6 months after initial evaluation

Study Arms (1)

Primary school 1st grade students

Cognitive tests and reading-related evaluations will be administered to illiterate first-grade primary school students before and 6 months after they start education.

Behavioral: Cognitive tests and reading-related evaluations

Interventions

Tests assessing cognitive status and reading were administered. (Frankfurter; MVPT-3, TILLs; etc.)

Primary school 1st grade students

Eligibility Criteria

Age72 Months - 96 Months
Sexall(Gender-based eligibility)
Gender Eligibility DetailsALL GENDER
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Primary School Students Aged 6-8.

You may qualify if:

  • Being 6 years old and above and starting primary school
  • Not knowing how to read and write
  • Not having received any previous literacy training
  • Knowing Turkish

You may not qualify if:

  • Having dyslexia
  • Being diagnosed with a neurological or psychiatric disease
  • Having an organic disorder such as hearing and vision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medipol Mega University Hospital

Istanbul, 34214, Turkey (Türkiye)

Location

Related Publications (32)

  • Gernsbacher MA, Kaschak MP. Neuroimaging studies of language production and comprehension. Annu Rev Psychol. 2003;54:91-114. doi: 10.1146/annurev.psych.54.101601.145128. Epub 2002 Jun 10.

    PMID: 12359916BACKGROUND
  • Safi D, Lefebvre P, Nader M. Literacy acquisition: Reading development. Handb Clin Neurol. 2020;173:185-199. doi: 10.1016/B978-0-444-64150-2.00017-4.

    PMID: 32958173BACKGROUND
  • Habib S. Learning and Teaching British Values [Internet]. Cham: Springer International Publishing; 2018 [a.yer 15 Aralık 2023]. Erişim adresi: http://link.springer.com/10.1007/978-3-319-60381-0

    BACKGROUND
  • Dehaene S, Cohen L, Morais J, Kolinsky R. Illiterate to literate: behavioural and cerebral changes induced by reading acquisition. Nat Rev Neurosci. 2015 Apr;16(4):234-44. doi: 10.1038/nrn3924. Epub 2015 Mar 18.

    PMID: 25783611BACKGROUND
  • Houde O, Rossi S, Lubin A, Joliot M. Mapping numerical processing, reading, and executive functions in the developing brain: an fMRI meta-analysis of 52 studies including 842 children. Dev Sci. 2010 Nov;13(6):876-85. doi: 10.1111/j.1467-7687.2009.00938.x.

    PMID: 20977558BACKGROUND
  • Bernhardt EB. "Reading in the Foreign Language." Listening, Reading, and Writing: Analysis and Application. Barbara HW, editör. Northeast Conference on the Teaching of Foreign Languages; 1986. 93- 11 s.

    BACKGROUND
  • Just MA, Carpenter PA. A capacity theory of comprehension: individual differences in working memory. Psychol Rev. 1992 Jan;99(1):122-49. doi: 10.1037/0033-295x.99.1.122.

    PMID: 1546114BACKGROUND
  • Whitehurst G, Lonigan C. Emergent literacy: Development from pre-readers to readers. Neuman S, Dickinson K, editörler. New York: Guilford: Handbook of early literacy research; 2001. 11-29 s.

    BACKGROUND
  • Nouwens S, Groen MA, Kleemans T, Verhoeven L. How executive functions contribute to reading comprehension. Br J Educ Psychol. 2021 Mar;91(1):169-192. doi: 10.1111/bjep.12355. Epub 2020 May 22.

    PMID: 32441782BACKGROUND
  • Miller MR, Müller U, Giesbrecht GF, Carpendale JI, Kerns KA. The contribution of executive function and social understanding to preschoolers' letter and math skills. Cognitive Development. 2013;28(4):331-49.

    BACKGROUND
  • Gallen CL, Schaerlaeken S, Younger JW; Project iLEAD Consortium; Anguera JA, Gazzaley A. Contribution of sustained attention abilities to real-world academic skills in children. Sci Rep. 2023 Feb 15;13(1):2673. doi: 10.1038/s41598-023-29427-w.

    PMID: 36792755BACKGROUND
  • McClelland MM, Acock AC, Piccinin A, Rhea SA, Stallings MC. Relations between Preschool Attention Span-Persistence and Age 25 Educational Outcomes. Early Child Res Q. 2013 Apr 1;28(2):314-324. doi: 10.1016/j.ecresq.2012.07.008. Epub 2012 Aug 3.

    PMID: 23543916BACKGROUND
  • Hoover WA, Gough PB. The simple view of reading. Read Writ. 01 Haziran 1990;2(2):127-60.

    BACKGROUND
  • Daigle D, Armand F, Armand F, Armand F. L'approche bilingue et l'apprentissage de la lecture chez les sourds. Revue de l'Association canadienne de linguistique appliquée (ACLA). 2004;7(1):23-38.

    BACKGROUND
  • Perfetti C, Stafura J. Word Knowledge in a Theory of Reading Comprehension. Scientific Studies of Reading. 2014;(18):22-37.

    BACKGROUND
  • Raatz U, Mhling R. Frankfurter tests für Fünfjhrige-Konzentration (FTF-K). Weinheim Beltz. 1971 [a.yer 15 Aralık 2023]; Erişim adresi: https://www.scirp.org/reference/referencespapers?referenceid=1626613

    BACKGROUND
  • Kaymak S. Yuvaya giden beş yaşındaki çocuklarla dikkat toplama çalışmaları [Yayınlanmamış yüksek lisans tezi]. [Ankara]: Ankara Üniversitesi Sosyal Bilimler Enstitüsü; 1995.

    BACKGROUND
  • Kurt M, Karakaş S. Sağ serebral hemisferin bilişsel işlevlerine duyarlı üç nöropsikolojik testin özellikleri ve aralarındaki ilişkiler. 3P Dergisi. 2000;(8):251-65.

    BACKGROUND
  • Kılıç BG, Irak M, Koçkar Aİ, Şener S, Karakaş S. İşaretleme Testi Türk Formu'nun 6-11 Yaş Grubu Çocuklarda Standardizasyon Çalışması. Klinik Psikiyatri Dergisi. 2002;5(4):213-28.

    BACKGROUND
  • Kurt M. Sağ serebral hemisferin bilişsel işlevlerine duyarlı nöropsikolojik testlerin faktör yapısının incelenmesi [Yayınlanmamış yüksek lisans tezi]. [Ankara]: Hacettepe Üniversitesi; 1998.

    BACKGROUND
  • Lezak M. Neuropsychological Assessment. 3. Baskı. New York: Oxford University Press; 1995.

    BACKGROUND
  • Weintraub S, Mesulam MM. Right cerebral dominance in spatial attention. Further evidence based on ipsilateral neglect. Arch Neurol. 1987 Jun;44(6):621-5. doi: 10.1001/archneur.1987.00520180043014.

    PMID: 3579679BACKGROUND
  • Wechsler D, The Wechsler Intelligence Scale for children. 3. bs. San Antonio, TX: The Psychological Corporation; 1991.

    BACKGROUND
  • Uluç S, Öktem F, Erden G, Gençöz T, Sezgin N. Wechsler Çocuklar için Zeka Ölçeği-IV: Klinik Bağlamda Zekanın Değerlendirilmesinde Türkiye için Yeni Bir Dönem. Türk Psikoloji Yazıları. 14(28):49-57.

    BACKGROUND
  • Cameron Ponitz CE, McClelland MM, Jewkes AM, Connor CM, Farris CL, Morrison FJ. Touch your toes! Developing a direct measure of behavioral regulation in early childhood. Early Childhood Research Quarterly. 01 Nisan 2008;23(2):141-58.

    BACKGROUND
  • McClelland MM, Cameron CE, Duncan R, Bowles RP, Acock AC, Miao A, Pratt ME. Predictors of early growth in academic achievement: the head-toes-knees-shoulders task. Front Psychol. 2014 Jun 17;5:599. doi: 10.3389/fpsyg.2014.00599. eCollection 2014.

    PMID: 25071619BACKGROUND
  • Akyürek G, Bumin G. Turkish Adaptation of The Executive Functions and Occupational Routines Scale (EFORTS) and Its Validity And Reliability. Dev Med Child Neurol. 2017;(59):2-18.

    BACKGROUND
  • Harber JR. Perception and perceptual-motor integration: there is a difference. Percept Mot Skills. 1979 Dec;49(3):917-8. doi: 10.2466/pms.1979.49.3.917.

    PMID: 530792BACKGROUND
  • Colarusso R, Hammil D. Motor-free perception test (MVPT-3). California: Academic Therapy Publication; 2003.

    BACKGROUND
  • Mailend ML, Plante E, Anderson MA, Applegate EB, Nelson NW. Reliability of the Test of Integrated Language and Literacy Skills (TILLS). Int J Lang Commun Disord. 2016 Jul;51(4):447-59. doi: 10.1111/1460-6984.12222. Epub 2016 Mar 27.

    PMID: 27018642BACKGROUND
  • Metin Ş, Aral N. Motor beceriden bağımsız görsel algı testi-3: Geçerlik güvenirlik çalışması. Çankırı Karatekin Üniversitesi Sosyal Bilimler Enstitüsü Dergisi. 2012;4(2):57-72.

    BACKGROUND
  • Atavasun Uysal S. Az Gören Çocuklarda İki Farklı Görsel Algılama Tedavisinin Etkinliğinin Karşılaştırılması [Doktora Tezi]. [Ankara]: Hacettepe Üniversitesi; 2009.

    BACKGROUND

MeSH Terms

Interventions

Neuropsychological Tests

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

August 9, 2024

First Posted

August 16, 2024

Study Start

October 2, 2023

Primary Completion

November 27, 2023

Study Completion

July 1, 2024

Last Updated

August 16, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations