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

July 26, 2022 updated by: Engy Elhakeem, Alexandria University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt, 21500
        • Faculty of medicine, Alexandria University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • children complaining of specific learning disorder and executive function deficits

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: study group
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
evidence based practice that target executive function skills in early elementary years.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-Management to Time.
Time Frame: 3-6 months
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
Time Frame: 3-6 months
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.
Time Frame: 3-6 months
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.
Time Frame: 3-6 months
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
Time Frame: 3-6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Investigators

  • Study Chair: Reham M Elmaghraby, MD, Otorhinolaryngology department, Faculty of Medicine, Alexandria University
  • Study Director: Engy S Elhakeem, MD, Otorhinolaryngology department, Faculty of Medicine, Alexandria University
  • Study Chair: Soha AL Ibrahim, MD, Neuropsychiatry department, Faculty of Medicine, Alexandria University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2018

Primary Completion (Actual)

March 10, 2020

Study Completion (Actual)

May 28, 2020

Study Registration Dates

First Submitted

July 15, 2022

First Submitted That Met QC Criteria

July 26, 2022

First Posted (Actual)

July 27, 2022

Study Record Updates

Last Update Posted (Actual)

July 27, 2022

Last Update Submitted That Met QC Criteria

July 26, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0106137

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

All statistical data are available in the study once published

IPD Sharing Time Frame

6 months after publishing

IPD Sharing Access Criteria

through the email address engy.elhakeem@alexmed.edu.eg

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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