Promoting Inclusive Education Through Executive Functions

NCT05472194 | Not Yet Recruiting

• 1 other identifier: EduFun2022
• Study Type: interventional
• Target: 470
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Cognitive Training

Keywords

Inclusive Education; Executive Functions; Cognitive Tools

Outcome Measures

Primary Outcomes (6)

• 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.

• 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.

• 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.

• 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.

• 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.

• 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 Outcomes (1)

• School Grades

  Through study completion, an average of 1 year.

Study Arms (2)

Experimental Condition

EXPERIMENTAL

Participants allocated to the Experimental condition will be following a cognitive training program using a set of game-based activities specifically developed to train executive functions.

Behavioral: InSchool Training Program

Control Condition

ACTIVE COMPARATOR

Participants allocated to the Control condition will be following the same sessions of the training program (similar to the Experimental group) while playing with a set of commonly used games within the school context (e.g. puzzles).

Behavioral: Regular school activities

Interventions

InSchool Training Program BEHAVIORAL

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.

Experimental Condition

Regular school activities BEHAVIORAL

Children in the control group will be playing with the regular school activities.

Control Condition

Eligibility Criteria

• Age: 5 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Minho: lead

Study Officials

• Sónia Sousa, PhD

  School of Psychology, University of Minho

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sónia Sousa, PhD

CONTACT

+351917824280; soniamachado@psi.uminho.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be randomly assigned for the experimental or control group with no information on the nature of the group they will be assigned. Additionally, no information about the training activities will be passed on to the participants.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The protocol includes a randomized controlled trial with a follow-up at six months involving two groups per age range (5,6 and 7Y) -a training group, which will be enrolled in the InSchool program and an active control group that will be participating in the regular kindergarten/elementary school activities. Participants will be randomly assigned to each group to control for inter-individual variability in executive functions' developmental level, which could distinctly impact the study results.

Study Record Dates

• First Submitted: June 23, 2022
• First Posted: July 25, 2022
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 9, 2027
• Study Completion (Estimated): December 9, 2027
• Last Updated: December 6, 2024

Record last verified: 2024-12