Promoting Inclusive Education Through Executive Functions

Cognitive Training Clinical Trial

— EduFun  

Official title:

Promoting Inclusive Education Through Executive Functions - Study Protocol of a Randomized Control Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05472194
• Other study ID #: EduFun2022
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: September 9, 2025

Study information

• Verified date: November 2023
• Source: University of Minho
• Contact: Sónia Sousa, PhD
• Phone: +351917824280
• Email: soniamachado[@]psi.uminho.pt
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Background: Recently governments worldwide have been doing enormous efforts to ensuring egalitarian educational opportunities for all children. However, the number of children that remain out of the school or lack proficiency in academic performance is still very worrying. One of the factors that seems to contribute to such inequalities is socioeconomic status (SES). SES strongly impacts the developmental trajectory of both the brain and cognitive abilities as off early childhood, further affecting learning and academic success.

Despite the great interest in building inclusive societies and the promising results of executive functions' training programs for leveling the SES-achievement disparities, only a few studies have actually included schools from low-SES settings and lack a comprehensive, evidence-based background underlying the intervention protocols. Thus, with a preventive emphasis, the current project aims to implementing and evaluating a cost-effective game-based training protocol to promote and boost the development of executive functions in preschool and elementary school-aged children from disadvantaged contexts, ultimately contributing to prevent school dropout and reduce academic inequalities.

Description:

A randomized controlled trial will be implemented in Portuguese schools embedded in low-income settings. It will include a total of 396 participants, 132 per age group: 5,6 and 7 years old. At each age group a total of 132 children will be enrolled in the program for 4 weeks, 66 in the active control group, and 66 in the intervention group. The assessment protocol will include demographics, including SES, and evaluation of executive functions. Both groups -control and intervention- will complete the same assessment protocol at three distinct moments -baseline, post-intervention, and 6 months' follow-up. The training program will comprise the following: (i) 3 weekly sessions of 30 minutes each (ii) each session will be dedicated to train a specific domain of executive functions -working memory, inhibition and cognitive flexibility.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 470
• Est. completion date: September 9, 2025
• Est. primary completion date: December 9, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 7 Years

Eligibility

Inclusion Criteria:

• Typically developed children of 5, 6, and 7 years old attending the regular curriculum at public educational services -kindergarten and elementary school.

Exclusion Criteria:

• Presence or history of cognitive deficits, neurological or psychiatric condition.

Related Conditions & MeSH terms

• Cognitive Training

Intervention

Behavioral:
• InSchool Training Program
The goal of the intervention is to promote and boost the development of executive functions in preschool and elementary school-aged children by means of engagement in meaningful and challenging activities. The method to achieve this consists on weekly intervention sessions run by teachers with a set of games specially developed to train executive functions.
• Regular school activities
Children in the control group will be playing with the regular school activities.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Minho

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Executive functions (Working memory)	Accuracy, measured through the number of hits, will be collected from the participant's performance on a working memory task, conducted using a digital platform specifically built to assess the hypothetical differences in participant's level of achievement between the pretest and posttest assessments.	Through study completion, an average of 1 year.
Primary	Executive functions (Working memory)	Reaction times, measured as seconds needed to give a response, will be collected from the participant's performance on a working memory task, conducted using a digital platform specifically built to assess the hypothetical differences in participant's level of achievement between the pretest and posttest assessments.	Through study completion, an average of 1 year.
Primary	Executive functions (Inhibitory control)	Accuracy, measured through the number of hits, will be collected from the participant's performance on an inhibitory control task, conducted using a digital platform specifically built to assess the hypothetical differences in participant's level of achievement between the pretest and posttest assessments.	Through study completion, an average of 1 year.
Primary	Executive functions (Inhibitory control)	Reaction times, measured as seconds needed to give a response, will be collected from the participant's performance on an inhibitory control task, conducted using a digital platform specifically built to assess the hypothetical differences in participant's level of achievement between the pretest and posttest assessments.	Through study completion, an average of 1 year.
Primary	Executive functions (set shifting)	Accuracy, measured through the number of hits, will be collected from the participant's performance on a set shifting task, conducted using a digital platform specifically built to assess the hypothetical differences in participant's level of achievement between the pretest and posttest assessments.	Through study completion, an average of 1 year.
Primary	Executive functions (set shifting)	Reaction times, measured as seconds needed to give a response, will be collected from the participant's performance on a set shifting task, conducted using a digital platform specifically built to assess the hypothetical differences in participant's level of achievement between the pretest and posttest assessments.	Through study completion, an average of 1 year.
Secondary	School Grades	Grades in math and Portuguese of each participant's current school year are the secondary outcomes and will be requested to their teachers. This measure will be applicable only to the 6 and 7 years old children.	Through study completion, an average of 1 year.