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Promoting Inclusive Education Through Executive Functions (EduFun)

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ClinicalTrials.gov Identifier: NCT05472194
Recruitment Status : Not yet recruiting
First Posted : July 25, 2022
Last Update Posted : July 27, 2022
Sponsor:
Information provided by (Responsible Party):
Sonia Sousa, University of Minho

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.


Condition or disease Intervention/treatment Phase
Cognitive Training Behavioral: InSchool Training Program Behavioral: Regular school activities Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 470 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Single (Participant)
Masking Description: 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.
Primary Purpose: Prevention
Official Title: Promoting Inclusive Education Through Executive Functions - Study Protocol of a Randomized Control Trial
Estimated Study Start Date : September 2023
Estimated Primary Completion Date : December 9, 2024
Estimated Study Completion Date : September 9, 2025

Arm Intervention/treatment
Experimental: Experimental Condition
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
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.

Active Comparator: Control Condition
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
Children in the control group will be playing with the regular school activities.




Primary Outcome Measures :
  1. Executive functions (Working memory) [ Time Frame: Through study completion, an average of 1 year. ]
    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.

  2. Executive functions (Working memory) [ Time Frame: Through study completion, an average of 1 year. ]
    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.

  3. Executive functions (Inhibitory control) [ Time Frame: Through study completion, an average of 1 year. ]
    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.

  4. Executive functions (Inhibitory control) [ Time Frame: Through study completion, an average of 1 year. ]
    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.

  5. Executive functions (set shifting) [ Time Frame: Through study completion, an average of 1 year. ]
    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.

  6. Executive functions (set shifting) [ Time Frame: Through study completion, an average of 1 year. ]
    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.


Secondary Outcome Measures :
  1. School Grades [ Time Frame: Through study completion, an average of 1 year. ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05472194


Contacts
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Contact: Sónia Sousa, PhD +351917824280 soniamachado@psi.uminho.pt

Sponsors and Collaborators
University of Minho
Investigators
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Principal Investigator: Sónia Sousa, PhD School of Psychology, University of Minho
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Responsible Party: Sonia Sousa, Principal Investigator, University of Minho
ClinicalTrials.gov Identifier: NCT05472194    
Other Study ID Numbers: EduFun2022
First Posted: July 25, 2022    Key Record Dates
Last Update Posted: July 27, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sonia Sousa, University of Minho:
Inclusive Education
Executive Functions
Cognitive Tools