Cognitive Function 1, SocialNCT06557382
Cognitive Skills and Reading Speed
An observational study of Cognitive Function 1, Social and Reading Problem, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 72 to 96 monthsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Function 1, Social, Reading Problem
- What is being tested?
- Cognitive tests and reading-related evaluations
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Oct 2023to 1 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 72 to 96 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Primary School Students Aged 6-8.
Who may be able to join
- 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
Who cannot join
- Having dyslexia
- Being diagnosed with a neurological or psychiatric disease
- Having an organic disorder such as hearing and vision
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Medipol Mega University Hospital
Istanbul, 34214
About this study
Official title: The Power of Cognitive Skills to Predict Reading Speed
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.
Read the detailed description
Learning to read is a very difficult process for both parents and children. Some children overcome this process more easily, while others have more difficulty. Understanding this process and the factors that affect it is important for developing academic skills. Reading is a complex, multifactorial, and dynamic process. When reading begins, parallel activation of limbic, motor, and cognitive processes occurs in different brain regions, including the cortex, thalamus, and basal ganglia. Orthographic word processes, phonological analysis, mapping between print, sound, and meaning, articulatory registration, and semantic/syntactic processing of written words occur through activation of left ventral occipitotemporal, dorsal temporoparietal, and left inferior frontal brain networks. During this process, the brain mentioned above networks establish connections with many areas of both hemispheres to enable comprehension. Reading skills involve the activation and interaction of cognitive processes such as attention, working memory, and executive control. Their study with 9-year-old children stated that planning skills are important for reading and that good inhibitory control increases phonotic coding skills. Miller and colleagues noted that the executive function subcomponents of working memory, but not inhibition, explained 52% of the variance in literacy and 81% of the variance in mathematics. Gallen and colleagues found that the ability to sustain attention was associated with reading and mathematics skills. McClelland and colleagues suggested that children with a higher standard deviation score in attention span at age 4 were 48.7% more likely to graduate from college by age 25. As can be seen, although reading skills have been linked to cognitive abilities in the literature, complete clarity has not been achieved. It would be appropriate to evaluate reading in general as word recognition/identification and reading comprehension skills. While word recognition involves lower-level cognitive processes, comprehension requires the automatization of lower-level cognitive skills coordinated with the effect of higher-level cognitive skills. In this context, it may be necessary to examine which cognitive skill can predict reading according to subheadings of reading such as reading speed and reading comprehension. If the relationship between cognitive skills and the speed of learning to read and reading comprehension is revealed, the performance of children at risk of falling behind in reading can be increased with additional measures. Since it will be predicted which of the children who have just started school will fall behind in learning to read by using the tests with high prediction coefficients to be determined at the end of the study, developmental measures can be taken for these children. In addition, it will be possible to focus on cognitive exercises to increase the success of these children in their educational lives.
The purpose of this study is to examine the relationship between cognitive skills in children who will learn to read and who do not have any diagnosis and reading speed and reading comprehension skills.
- Conditions
- Cognitive Function 1, Social, Reading Problem
- Being tested
- Cognitive tests and reading-related evaluations
- Keywords
- cognitive skills, predict reading speed, child
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive tests and reading-related evaluationsBehavioural
Tests assessing cognitive status and reading were administered. (Frankfurter; MVPT-3, TILLs; etc.)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Cognitive tests and reading-related evaluations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months after initial evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start2 Oct 2023
- Primary completion27 Nov 2023
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Cognitive Function 1, SocialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ozden erkan, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06557382
- Sponsor's protocol ID
- E-10840098-772.02-8008
- Status last verified
- Aug 2024
- First submitted
- 9 Aug 2024
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 12359916Safi 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.
PubMed 32958173Habib 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
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.
PubMed 25783611Houde 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.
PubMed 20977558Bernhardt 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.
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.
PubMed 1546114Whitehurst 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.
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.
PubMed 32441782Miller 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.
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.
PubMed 36792755McClelland 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.
PubMed 23543916Hoover WA, Gough PB. The simple view of reading. Read Writ. 01 Haziran 1990;2(2):127-60.
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.
Perfetti C, Stafura J. Word Knowledge in a Theory of Reading Comprehension. Scientific Studies of Reading. 2014;(18):22-37.
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Power of Cognitive Skills to Predict Reading Speed
- ClinicalTrials.gov ID
- NCT06557382
- Acronym / sponsor ID
- E-10840098-772.02-8008
- Conditions
- Cognitive Function 1, Social, Reading Problem
- Keywords
- cognitive skills, predict reading speed, child
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 27 Nov 2023 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 16 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Learning to read is a very difficult process for both parents and children. Some children overcome this process more easily, while others have more difficulty. Understanding this process and the factors that affect it is important for developing academic skills. Reading is a complex, multifactorial, and dynamic process. When reading begins, parallel activation of limbic, motor, and cognitive processes occurs in different brain regions, including the cortex, thalamus, and basal ganglia. Orthographic word processes, phonological analysis, mapping between print, sound, and meaning, articulatory registration, and semantic/syntactic processing of written words occur through activation of left ventral occipitotemporal, dorsal temporoparietal, and left inferior frontal brain networks. During this process, the brain mentioned above networks establish connections with many areas of both hemispheres to enable comprehension. Reading skills involve the activation and interaction of cognitive processes such as attention, working memory, and executive control. Their study with 9-year-old children stated that planning skills are important for reading and that good inhibitory control increases phonotic coding skills. Miller and colleagues noted that the executive function subcomponents of working memory, but not inhibition, explained 52% of the variance in literacy and 81% of the variance in mathematics. Gallen and colleagues found that the ability to sustain attention was associated with reading and mathematics skills. McClelland and colleagues suggested that children with a higher standard deviation score in attention span at age 4 were 48.7% more likely to graduate from college by age 25. As can be seen, although reading skills have been linked to cognitive abilities in the literature, complete clarity has not been achieved. It would be appropriate to evaluate reading in general as word recognition/identification and reading comprehension skills. While word recognition involves lower-level cognitive processes, comprehension requires the automatization of lower-level cognitive skills coordinated with the effect of higher-level cognitive skills. In this context, it may be necessary to examine which cognitive skill can predict reading according to subheadings of reading such as reading speed and reading comprehension. If the relationship between cognitive skills and the speed of learning to read and reading comprehension is revealed, the performance of children at risk of falling behind in reading can be increased with additional measures. Since it will be predicted which of the children who have just started school will fall behind in learning to read by using the tests with high prediction coefficients to be determined at the end of the study, developmental measures can be taken for these children. In addition, it will be possible to focus on cognitive exercises to increase the success of these children in their educational lives.
The purpose of this study is to examine the relationship between cognitive skills in children who will learn to read and who do not have any diagnosis and reading speed and reading comprehension skills.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary school 1st grade students | – | Behavioral: Cognitive tests and reading-related evaluationsCognitive tests and reading-related evaluations will be administered to illiterate first-grade primary school students before and 6 months after they start education. |
Who may qualify
- Ages
- 72 to 96 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Primary School Students Aged 6-8.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Having dyslexia
- Being diagnosed with a neurological or psychiatric disease
- Having an organic disorder such as hearing and vision
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive tests and reading-related evaluationsTests assessing cognitive status and reading were administered. (Frankfurter; MVPT-3, TILLs; etc.) | Behavioural | Primary school 1st grade students |
Primary outcome
Frankfurter tests
Time frame: Baseline and 6 months after initial evaluation
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.
Cancellation Test
Time frame: Baseline and 6 months after initial evaluation
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.
Executive Functions and Occupational Routines Scale (EFORTS)
Time frame: Baseline and 6 months after initial evaluation
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.
Forward and Backward Digit Span
Time frame: Baseline and 6 months after initial evaluation
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.
The Head-Toes-Knees-Shoulders
Time frame: Baseline and 6 months after initial evaluation
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.
Motor-free Perception Test (MVPT-3).
Time frame: Baseline and 6 months after initial evaluation
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.
Test of Integrated Language and Literacy Skills (TILLS)
Time frame: 6 months after initial evaluation
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
- Background: PubMed 12359916Gernsbacher 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.
- Background: PubMed 32958173Safi 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.
- BackgroundHabib 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: PubMed 25783611Dehaene 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.
- Background: PubMed 20977558Houde 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.
- BackgroundBernhardt 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: PubMed 1546114Just 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.
- BackgroundWhitehurst 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: PubMed 32441782Nouwens 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.
- BackgroundMiller 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: PubMed 36792755Gallen 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.
- Background: PubMed 23543916McClelland 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Function 1, Social and Reading Problem, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frankfurter tests (time frame: Baseline and 6 months after initial evaluation). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06557382, which also lists 32 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2024.