Cognitive TrainingEduFunNCT05472194
Promoting Inclusive Education Through Executive Functions
A study testing InSchool Training Program and Regular school activities in people with Cognitive Training, run by University of Minho.
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. Read more about this study
- Who is it for?
- Ages 5 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Training
- What is being tested?
- InSchool Training Program and Regular school activities
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 470 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to 9 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Typically developed children of 5, 6, and 7 years old attending the regular curriculum at public educational services -kindergarten and elementary school.
Who cannot join
- Presence or history of cognitive deficits, neurological or psychiatric condition.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Promoting Inclusive Education Through Executive Functions - Study Protocol of a Randomized Control Trial
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.
- Conditions
- Cognitive Training
- Being tested
- InSchool Training Program, Regular school activities
- Keywords
- Inclusive Education, Executive Functions, Cognitive Tools
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InSchool Training ProgramBehavioural
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 activitiesBehavioural
Children in the control group will be playing with the regular school activities.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Behavioral: Regular school activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study startSep 2025 (estimated)
- Primary completion9 Dec 2027 (estimated)
- Study completion9 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive TrainingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant
- Enrolment
- 470 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sonia Sousa, University of Minho
- Investigators
- Sónia Sousa, PhD, Principal investigator, School of Psychology, University of Minho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05472194
- Sponsor's protocol ID
- EduFun2022
- Acronym
- EduFun
- Status last verified
- Dec 2024
- First submitted
- 23 Jun 2022
- Last updated
- 6 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Inclusive Education Through Executive Functions - Study Protocol of a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05472194
- Acronym / sponsor ID
- EduFun / EduFun2022
- Conditions
- Cognitive Training
- Keywords
- Inclusive Education, Executive Functions, Cognitive Tools
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 470 participants (estimated)
- Lead sponsor
- University of MinhoUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- 9 Dec 2027 (estimated)
- Study completion
- 9 Dec 2027 (estimated)
- First posted
- 25 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental Condition | Experimental | Behavioral: InSchool Training ProgramParticipants 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. |
| Control Condition | Active comparator | Behavioral: Regular school activitiesParticipants 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). |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Typically developed children of 5, 6, and 7 years old attending the regular curriculum at public educational services -kindergarten and elementary school.
Key exclusion criteria (1 listed)
- Presence or history of cognitive deficits, neurological or psychiatric condition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InSchool Training ProgramThe 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. | Behavioural | Experimental Condition |
| Regular school activitiesChildren in the control group will be playing with the regular school activities. | Behavioural | Control Condition |
Primary outcome
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.
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.
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.
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.
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.
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.
1 secondary outcome
School Grades
Time frame: Through study completion, an average of 1 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sónia Sousa, PhD principal investigator
School of Psychology, University of Minho
Questions about this trial
What is this clinical trial studying?
A study testing InSchool Training Program and Regular school activities in people with Cognitive Training, run by University of Minho.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sónia Sousa, PhD (+351917824280, soniamachado@psi.uminho.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Executive functions (Working memory) (time frame: Through study completion, an average of 1 year.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.