AzTrials
AzTrials

Learning DisordersNCT05476133

Application of a Training Program for Executive Functions in a Sample of Egyptian Children With Learning Disorder

A study testing Executive functions training-elementary and Promoting executive function in in the classroom in people with Learning Disorders and Executive Dysfunction, run by Alexandria University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

In recent years, significant progress has been made on ways to improve Executive Functions (EF) skills for school readiness involving direct EF training and classroom educational programs. Read more about this study

Who is it for?
Ages 6 to 11 yearsHealthy volunteers can take part
Conditions the study is for
Learning Disorders, Executive Dysfunction
What is being tested?
Executive functions training-elementary and Promoting executive function in in the classroom
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteEgypt
Study dates
15 Jan 2018to 28 May 2020
Phase
Interventional
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 6 to 11 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • children complaining of specific learning disorder and executive function deficits

Who cannot join

  • brain damage, mentally retarded or history of fits or subclinical fits
  • hearing or visual impairment
  • psychic problems

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Faculty of Medicine, Alexandria University

    Alexandria, 21500

Other trials in Egypt

About this study

In recent years, significant progress has been made on ways to improve Executive Functions (EF) skills for school readiness involving direct EF training and classroom educational programs. Due to the absence of a well-structured Arabic program for EF training in children, the rationale of this study is to implement a comprehensive, evidence-based intervention program to help Egyptian children with learning disorders to overcome their EF impairment. It uses the multimodality approach to help meet the needs of students with a variety of learning styles. The aim of this study is to adapt the combined form of the "Executive Functions Training-Elementary", and the "Promoting Executive Function In The Classroom" programs and its application in order to test its effectiveness in the rehabilitation of Egyptian learning disordered children.

Read the detailed description

The study was conducted on 40 children with dyslexia and Executive dysfunction attending unit of phoniatrics, Otorhinolaryngology department, Alexandria University. The results were compared before and after intervention.

The "Executive Functions Training-Elementary" program is an evidence-based practice that targets Executive function skills in the early elementary years by training students how to plan, execute, complete, and monitor tasks. It develops cognitive abilities and behavior control with classroom-related activities for varying ability levels.

The "Promoting Executive Function In The Classroom" program helps to incorporate Executive function processes (such as planning, organization, prioritizing, and self-checking) into the classroom curriculum. Chapters provide effective strategies for learning by improving how to learn.

Data were collected and entered to the computer using (Statistical Package for Social Science) program for statistical analysis (version 21).

Data were entered as numerical or categorical, as appropriate. Kolmogorov-Smirnov test of normality revealed no significance in the distribution of the variables, so the parametric statistics was adopted.

Data were described using minimum, maximum, mean, standard deviation and 95% Confidence Interval of the mean.

Categorical variables were described using frequency and percentage. Comparisons were carried out between two studied dependent normally distributed variables using paired t-test.

Comparisons were carried out between more than two independent normally distributed subgroups using one-way Analysis Of Variance (ANOVA) test. When F ratio of ANOVA was significant Levene test of homogeneity of variances was done, and if significant Brown-Forsythe Robust test was adopted. Post-hoc multiple comparisons was done using Games-Howell.

Being tested
Executive functions training-elementary and Promoting executive function in in the classroom
Keywords
Executive Functions, learning disorder, children
Medical subject headings
Learning Disabilities

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Executive functions training-elementary and Promoting executive function in in the classroomOther

    evidence based practice that target executive function skills in early elementary years.

Study groups in NCT05476133
Study groupRoleWhat they receive
study groupExperimentalsingle group who had intervention and comparison of pre and post intervention assessment
Receives: Other: Executive functions training-elementary and Promoting executive function in in the classroom

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Self-Management to Time.

    scored from 1-4 depending on the parent's answers concerning the child's performance in this item in the last 6 months

    Measured: 3-6 months

  2. Self-Organization and Problem-Solving

    scored from 1-4 depending on the parent's answers concerning the child's performance in this item in the last 6 months

    Measured: 3-6 months

  3. Self-Restraint.

    scored from 1-4 depending on the parent's answers concerning the child's performance in this item in the last 6 months

    Measured: 3-6 months

  4. Self-Motivation.

    scored from 1-4 depending on the parent's answers concerning the child's performance in this item in the last 6 months

    Measured: 3-6 months

  5. Self-Regulation of Emotion

    scored from 1-4 depending on the parent's answers concerning the child's performance in this item in the last 6 months

    Measured: 3-6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2022
  2. Study start15 Jan 2018
  3. Primary completion10 Mar 2020
  4. Study completion28 May 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
the study was carried on a single group underwent initial assessment then intervention then final assessment
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05476133
Sponsor's protocol ID
0106137
Status last verified
Jul 2022
First submitted
15 Jul 2022
Last updated
27 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All statistical data are available in the study once published

Publications

  • Barbosa T, Rodrigues CC, Mello CB, Silva MCSE, Bueno OFA. Executive functions in children with dyslexia. Arq Neuropsiquiatr. 2019 May 13;77(4):254-259. doi: 10.1590/0004-282X20190033.

    PubMed 31090806

  • 3. Medapati N, Periasamy A. Comparing efficiency of executive functions between players and non-players of organized sport. Int J Physiol Nutr Phys Educ 2019; 1: 75-8.

  • Doebel S. Rethinking Executive Function and Its Development. Perspect Psychol Sci. 2020 Jul;15(4):942-956. doi: 10.1177/1745691620904771. Epub 2020 Apr 29.

    PubMed 32348707

  • Cortes Pascual A, Moyano Munoz N, Quilez Robres A. The Relationship Between Executive Functions and Academic Performance in Primary Education: Review and Meta-Analysis. Front Psychol. 2019 Jul 11;10:1582. doi: 10.3389/fpsyg.2019.01582. eCollection 2019.

    PubMed 31354585

  • Baddeley A. Working memory: theories, models, and controversies. Annu Rev Psychol. 2012;63:1-29. doi: 10.1146/annurev-psych-120710-100422. Epub 2011 Sep 27.

    PubMed 21961947

  • Nguyen T, Duncan G J. Kindergarten components of executive function and third grade achievement: A national study. Early Childhood Res Q 2018; 2:1-13

  • Op den Kelder R, Van den Akker AL, Geurts HM, Lindauer RJL, Overbeek G. Executive functions in trauma-exposed youth: a meta-analysis. Eur J Psychotraumatol. 2018 May 3;9(1):1450595. doi: 10.1080/20008198.2018.1450595.

    PubMed 33488998

  • Alsaedi RH, Carrington S, Watters JJ. Behavioral and Neuropsychological Evaluation of Executive Functions in Children with Autism Spectrum Disorder in the Gulf Region. Brain Sci. 2020 Feb 22;10(2):120. doi: 10.3390/brainsci10020120.

    PubMed 32098341

  • Lensing N, Elsner B. Development of hot and cool executive functions in middle childhood: Three-year growth curves of decision making and working memory updating. J Exp Child Psychol. 2018 Sep;173:187-204. doi: 10.1016/j.jecp.2018.04.002. Epub 2018 May 7.

    PubMed 29734050

  • Sung J, Wickrama K. Longitudinal relationship between early academic achievement and executive function: Mediating role of approaches to learning. Contemp Educ Psychol 2018; 24: 171-83

  • Duran C, Byers A, Cameron CE, Grissmer D. Unique and compensatory associations of executive functioning and visuomotor integration with mathematics performance in early elementary school. Early Child Res Q 2018; 42: 21-30.

  • Huang Y, He M, Li A, Lin Y, Zhang X, Wu K. Personality, Behavior Characteristics, and Life Quality Impact of Children with Dyslexia. Int J Environ Res Public Health. 2020 Feb 22;17(4):1415. doi: 10.3390/ijerph17041415.

    PubMed 32098297

  • Hebert M, Kearns DM, Hayes JB, Bazis P, Cooper S. Why Children With Dyslexia Struggle With Writing and How to Help Them. Lang Speech Hear Serv Sch. 2018 Oct 24;49(4):843-863. doi: 10.1044/2018_LSHSS-DYSLC-18-0024.

    PubMed 30458545

  • Meixner JM, Warner GJ, Lensing N, Schiefele U. The relation between executive functions and reading comprehension in primary-school students: A cross-lagged-panel analysis. Early Childhood Res Q 2018; 46: 1-13.

  • Cragg L, Keeble S, Richardson S, Roome HE, Gilmore C. Direct and indirect influences of executive functions on mathematics achievement. Cognition. 2017 May;162:12-26. doi: 10.1016/j.cognition.2017.01.014. Epub 2017 Feb 9.

    PubMed 28189034

Questions about this trial

What is this clinical trial studying?

A study testing Executive functions training-elementary and Promoting executive function in in the classroom in people with Learning Disorders and Executive Dysfunction, run by Alexandria University at 1 site in Egypt.

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 1 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 27 Jul 2022. 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 Egypt. 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?

Self-Management to Time. (time frame: 3-6 months). The study lists 5 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 NCT05476133, which also lists 16 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 27 Jul 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in