ClinicalTrials.gg
Not yet recruitingNCT05472194EduFunUpdated Dec 6, 2024

Promoting Inclusive Education Through Executive Functions

An interventional study of InSchool Training Program and Regular school activities in Cognitive Training, sponsored by University of Minho. Not yet recruiting. Open to participants aged 5 Years to 7 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-06.

Sponsored by University of Minho · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
470
Allocation
Randomized
Ages
5 Years to 7 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cognitive Training

Keywords

  • Inclusive Education
  • Executive Functions
  • Cognitive Tools
03

In context

Lead sponsor

University of Minho is the lead sponsor of 39 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 7 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Presence or history of cognitive deficits, neurological or psychiatric condition.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
470 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • BehavioralInSchool 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.

  • BehavioralRegular school activities

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Through study completion, an average of 1 year.

  2. 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.

    Time frame: Through study completion, an average of 1 year.

  3. 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.

    Time frame: Through study completion, an average of 1 year.

  4. 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.

    Time frame: Through study completion, an average of 1 year.

  5. 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.

    Time frame: Through study completion, an average of 1 year.

  6. 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.

    Time frame: Through study completion, an average of 1 year.

Secondary outcomes

  1. 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.

    Time frame: Through study completion, an average of 1 year.

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2025; primary completion for Dec 2027, 27 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 23, 2022
First posted
Jul 25, 2022
StartEst.
Sep 2025
Primary completionEst.
Dec 9, 2027
CompletionEst.
Dec 9, 2027
Last update
Dec 6, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05472194
Lead sponsor
University of Minho
Responsible party
Sonia Sousa (Principal Investigator, University of Minho) — Principal investigator
First posted
Jul 25, 2022
Start date
Sep 2025 (estimated)
Primary completion
Dec 9, 2027 (estimated)
Completion
Dec 9, 2027 (estimated)
Last update
Dec 6, 2024

Study contacts

Sónia Sousa, PhD
Contact
soniamachado@psi.uminho.pt
+351917824280
Sónia Sousa, PhD
principal investigator · School of Psychology, University of Minho

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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