NCT05476133

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

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

January 15, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2020

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

July 15, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 27, 2022

Completed
Last Updated

July 27, 2022

Status Verified

July 1, 2022

Enrollment Period

2.2 years

First QC Date

July 15, 2022

Last Update Submit

July 26, 2022

Conditions

Keywords

Executive Functionslearning disorderchildren

Outcome Measures

Primary Outcomes (5)

  • 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

    3-6 months

  • 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

    3-6 months

  • 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

    3-6 months

  • 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

    3-6 months

  • 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

    3-6 months

Study Arms (1)

study group

EXPERIMENTAL

single group who had intervention and comparison of pre and post intervention assessment

Other: Executive functions training-elementary and Promoting executive function in in the classroom

Interventions

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

study group

Eligibility Criteria

Age6 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • children complaining of specific learning disorder and executive function deficits

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Alexandria University

Alexandria, 21500, Egypt

Location

Related Publications (16)

  • 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.

    PMID: 31090806BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 32348707BACKGROUND
  • 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.

    PMID: 31354585BACKGROUND
  • 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.

    PMID: 21961947BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 33488998BACKGROUND
  • 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.

    PMID: 32098341BACKGROUND
  • 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.

    PMID: 29734050BACKGROUND
  • 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

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 32098297BACKGROUND
  • 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.

    PMID: 30458545BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 28189034BACKGROUND
  • Nesbitt KT, Fuhs MW, Farran DC. Stability and instability in the co-development of mathematics, executive function skills, and visual-motor integration from prekindergarten to first grade. Early Childhood Res Q 2018; 1:1-13.

    BACKGROUND

MeSH Terms

Conditions

Learning Disabilities

Condition Hierarchy (Ancestors)

Communication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Officials

  • Reham M Elmaghraby, MD

    otorhinolaryngology department, Faculty of Medicine, Alexandria University

    STUDY CHAIR
  • Engy S Elhakeem, MD

    otorhinolaryngology department, Faculty of Medicine, Alexandria University

    STUDY DIRECTOR
  • Soha AL Ibrahim, MD

    Neuropsychiatry department, Faculty of Medicine, Alexandria University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: the study was carried on a single group underwent initial assessment then intervention then final assessment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of phoniatrics

Study Record Dates

First Submitted

July 15, 2022

First Posted

July 27, 2022

Study Start

January 15, 2018

Primary Completion

March 10, 2020

Study Completion

May 28, 2020

Last Updated

July 27, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will share

All statistical data are available in the study once published

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
6 months after publishing
Access Criteria
through the email address engy.elhakeem@alexmed.edu.eg

Locations