- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06935656
Effectiveness of Three Executive Function Interventions on Direct and Far Transfer in Chilean School Children
December 19, 2025 updated by: nicholas napolitano, University of Talca
Executive functions (EF) are a set of effortful cognitive processes that allow children to control their thoughts, emotions, behaviors, update information in their memory and be mentally flexible.
The literature shows that the development of EF is essential for school success, in addition to being an important predictor of quality of life in adulthood.
As a result, numerous interventions have sought to stimulate EF development through different programs and formats, typically reporting moderate effectiveness in improving core EF components.
However, evidence for effects on untrained, domain-specific areas, such as academic performance, is less consistent.
One explanation for these mixed findings may lie in the heterogeneity of interventions and participant characteristics; particularly regarding the modality of the intervention (e.g., using digital media versus traditional media) and children's stage of development.
Although the current literature suggests these factors moderate intervention efficacy, there is a lack of randomized controlled trials that compare these variables within a single design.
To address this gap, a randomized controlled study has been proposed, aimed at examining an EF intervention delivered in one of three modalities-traditional (paper-and-pencil), digital (computer-based), and mixed-in low-income, urban Chilean school children at two developmental stages (5-6 years and 9-10 years).
Each program will target core EF components and measure both efficacy in EF improvement and outcomes in literacy and math skills.
By contrasting these intervention modalities across distinct age groups, this study seeks to identify whether developmental level and format have moderating effects on EF improvement and academic performance.
Our findings will contribute to ongoing debates about the best practices for EF stimulation, potentially informing evidence-based interventions that can be scaled or adapted for children at different developmental stages and in under-resourced settings.
In doing so, this research seeks to clarify how, when, and for whom EF interventions yield lasting benefits beyond immediate cognitive skills.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
192
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maule Region
-
Talca, Maule Region, Chile, 07762
- Municipal School 2
-
Talca, Maule Region, Chile, 07762
- Municipal School 4
-
Talca, Maule Region, Chile, 07762
- Municipal School 5
-
Talca, Maule Region, Chile
- Municipal School 1
-
Talca, Maule Region, Chile
- Municipal School 3
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Schools must be classified by the Chilean government as being public elementary schools located in an urban setting, with a proportion of vulnerability of at least 70% or greater (index for socioeconomic status). Schools also must contain at least one kindergarten class.
- For participants, the children must be regularly attending either kindergarten, or the fourth or fifth grade.
Exclusion Criteria:
- Schools that are considered rural, private or subsidized are not eligible. Additionally, schools that have a vulnerability index of less than 70% are not eligible.
- For participants, children with an intellectual disability, or are unable to understand and speak Spanish, will be excluded from the data analysis.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 5-6 year old group
This arm is made up of the younger group of participants (aged 5-6 years old) who will be randomly assigned to one of the three interventions.
|
This intervention contains activities that have been designed to stimulate the development of children's executive functioning (working memory, inhibitory control and cognitive flexibility).
Each activity is presented as a game, and each executive function is stimulated for an equal amount of time through activities that require motor skills, the manipulation of cards and the use of paper and pencil tasks.
This intervention contains activities that have been designed to stimulate the development of children's executive functioning (working memory, inhibitory control and cognitive flexibility).
Each activity is presented as a game, and each executive function is stimulated for an equal amount of time.
Half of the intervention sessions utilize activities that require motor skills, the manipulation of cards and the use of paper and pencil tasks, and the other half are activities that are completed on a tablet.
This intervention contains activities that have been designed to stimulate the development of children's executive functioning (working memory, inhibitory control and cognitive flexibility).
Each activity is presented in a gamified environment, and each executive function is stimulated for an equal amount of time through activities that children complete on a tablet.
|
|
Experimental: 9-10 year old group
This arm is made up of the older group of participants (aged 9-10 years old) who will be randomly assigned to one of the three interventions.
|
This intervention contains activities that have been designed to stimulate the development of children's executive functioning (working memory, inhibitory control and cognitive flexibility).
Each activity is presented as a game, and each executive function is stimulated for an equal amount of time through activities that require motor skills, the manipulation of cards and the use of paper and pencil tasks.
This intervention contains activities that have been designed to stimulate the development of children's executive functioning (working memory, inhibitory control and cognitive flexibility).
Each activity is presented as a game, and each executive function is stimulated for an equal amount of time.
Half of the intervention sessions utilize activities that require motor skills, the manipulation of cards and the use of paper and pencil tasks, and the other half are activities that are completed on a tablet.
This intervention contains activities that have been designed to stimulate the development of children's executive functioning (working memory, inhibitory control and cognitive flexibility).
Each activity is presented in a gamified environment, and each executive function is stimulated for an equal amount of time through activities that children complete on a tablet.
|
|
No Intervention: 5-6 year old TAU group
This arm is made up of the younger group of participants (aged 5-6 years old) who will be randomly assigned to no intervention, and will receive their normal schooling.
|
|
|
No Intervention: 9-10 year old TAU group
This arm is made up of the older group of participants (aged 9-10 years old) who will be randomly assigned to no intervention, and will receive their normal schooling.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in working memory
Time Frame: From baseline to end of intervention at 12 weeks
|
Working memory will be measured using a direct task known as the Corsi Block Test.
The test has an internal consistency of 0.93 (95% confidence interval of 0.84 - 0.97) in children ages 10-11 years.
Participants will see nine blocks on a screen.
The participant will be instructed to watch a sequence of blocks that illuminate.
The participant will need to replicate the sequence by touching the blocks on the screen.
Sequences begin simple (2 blocks) and become more difficult throughout the trials (up to 9 blocks).
A score is determined by the number of errors and the number of correct responses.
A higher score indicates better working memory.
|
From baseline to end of intervention at 12 weeks
|
|
Change from baseline in inhibitory control
Time Frame: From baseline to end of intervention at 12 weeks
|
To measure inhibitory control, the Hearts and Flowers task will be used.
Participants will watch a stimulus of either a heart or a flower in the center of a screen.
In the congruent trials, participants will respond with the same stimulus by touching either the smaller heart or flower to the left or right (respectively) of the main stimulus on screen.
In the incongruent trials, the opposite of the stimulus must be touched.
Reaction time and accuracy are both collected from each trial.
Lower reaction time and more accurate responses indicate better inhibitory control.
This task was adapted in Chile and had a Cronbach's alpha of 0.83 in children aged 6 to 10 years.
|
From baseline to end of intervention at 12 weeks
|
|
Change from baseline in cognitive flexibility
Time Frame: From baseline to end of intervention at 12 weeks
|
Cognitive flexibility will be measured using a modified version of the Dimensional Change Card Sort.
This task requires participants to group images on cards first using two dimensions: shape in the first set of trials, then color in the second set.
Next, in the third set of trials, participants are asked to group images on cards based on three dimensions: shape, color, or quantity.
Reaction time and accuracy are recorded from each trial.
Lower reaction time and better accuracy indicate better cognitive flexibility.
This instrument has not been validated in Chile but has a reliability coefficient of 0.92 in children aged 6-15 years.
|
From baseline to end of intervention at 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in literacy
Time Frame: From baseline to end of intervention at 12 weeks
|
The Tejas LEE instrument will be used to measure literacy.
This is a standardized instrument designed for children from kindergarten to third grade.
It evaluates various reading competencies through four scales and was adapted in Chile.
In each of the scales, higher accuracy of responses indicates better literacy.
|
From baseline to end of intervention at 12 weeks
|
|
Change from baseline in math ability
Time Frame: From baseline to end of intervention at 12 weeks
|
The Woodcock-Muñoz III Battery will be used to measure mathematical skills.
This test was adapted from English to Spanish and contains several subtests designed to assess mathmatical skills.
In each of the subtests, higher accuracy scores indicate better math skills.
Among Spanish-speaking children aged four to 13 years, the reliabilities of these subtests range between 0.84 and 0.97.
|
From baseline to end of intervention at 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 5, 2025
Primary Completion (Actual)
November 26, 2025
Study Completion (Actual)
December 18, 2025
Study Registration Dates
First Submitted
April 4, 2025
First Submitted That Met QC Criteria
April 15, 2025
First Posted (Actual)
April 20, 2025
Study Record Updates
Last Update Posted (Actual)
December 22, 2025
Last Update Submitted That Met QC Criteria
December 19, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 21231300
- 45/2024 (Other Identifier: University of Talca Scientific Ethics Committee)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
The study will follow open science guidelines in that the anonymized data and the R analysis script will be made available on the OSF registry of this study.
Parents and guardians will be informed of this process in the informed consent form.
IPD Sharing Time Frame
The protocol, SAP and ICF are currently available on the OSF study registry (start date: March 11, 2025).
Analytic code will be when the statistical analyses are complete (estimated date: June, 2026).
This data will be available for five years, as per guidelines set by the University of Talca's Scientific Ethics Commitee.
IPD Sharing Access Criteria
Anyone with the provided link will be able to access this information.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Study Data/Documents
-
All of the information regarding the Consent forms, IRB certificate as well as the analytic code and data can be found here.
Information identifier: DOI 10.17605/OSF.IO/Y4SGJInformation comments: The analytic code and data will be uploaded once the data is collected (est. December, 2025) and analyzed (est. June, 2026)
- Study Protocol
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Executive Functions
-
Universidad Nacional de Educación a DistanciaMinistry of Economy and Competitiveness (MINECO) - Government of SpainUnknownMemory Functions | Executive FunctionsSpain
-
European University Miguel de CervantesCentro Doctor Villacián, Valladolid, SpainCompleted
-
Shenzhen UniversityNot yet recruitingExecutive Functions (EF)
-
University of British ColumbiaNatural Sciences and Engineering Research Council, CanadaRecruitingPostural Balance | Executive FunctionsCanada
-
Penn State UniversityNational Dairy CouncilNot yet recruitingMicrobiome | Dietary Quality | Executive Functions (EF)United States
-
Universidad de AntioquiaClub La NororientalCompletedDecision Making in Soccer Players and Executive FunctionsColombia
-
University of California, IrvineWithdrawnThe Effects of Exercise on Executive FunctionsUnited States
-
Bahçeşehir UniversityNot yet recruitingHealthy Participants | Cognition | Vagus Nerve Stimulation | Neuromodulation | Sex Differences | Cognitive Assessment | Executive Functions | taVNS
-
School of Health Sciences GenevaUniversity of Lausanne Hospitals; University of Geneva, SwitzerlandRecruitingMagnetic Resonance Imaging | Behavior | Functional Magnetic Resonance Imaging | Music | Development, Child | Brain Imaging | Executive Functions | Brain Plasticity | Interventions | Arts | Structural Brain ConnectivitySwitzerland
-
Vittore Buzzi Children's HospitalTerminated
Clinical Trials on Traditional executive function intervention
-
Koronis Biomedical TechnologiesNational Institute of Mental Health (NIMH); University of Minnesota; Mount Sinai...RecruitingCognitive Intervention to Promote Healthy Development of Executive Function (EF) Skills in Young ChildrenUnited States
-
University of SheffieldUniversity of NottinghamCompletedCognitive DevelopmentUnited Kingdom
-
University of Missouri, Kansas CityUniversity of KansasUnknownPosttraumatic Stress DisordersUnited States
-
Xinhua Hospital, Shanghai Jiao Tong University...Completed
-
Education University of Hong KongRecruiting
-
Sohag UniversityNot yet recruitingExecutive Dysfunction | Stuttering, ChildhoodEgypt
-
Xinhua Hospital, Shanghai Jiao Tong University...Active, not recruitingADHD | Child, OnlyChina
-
Concordia University, MontrealCanadian Institutes of Health Research (CIHR)CompletedAging | Age Related Hearing LossCanada
-
ZIli FanUnknown
-
Kessler FoundationNational Institute on Disability, Independent Living, and Rehabilitation...RecruitingTBI (Traumatic Brain Injury)United States