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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
192

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Cristian A Rojas-Barahona, PhD
  • Phone Number: +56-71-2417361
  • Email: crojas@utalca.cl

Study Locations

  • Chile
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Traditional executive function intervention
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.
Other: Mixed executive function intervention
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.
Other: Tablet-based executive function intervention
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.
Other: Traditional executive function intervention
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.
Other: Mixed executive function intervention
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.
Other: Tablet-based executive function intervention
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Talca

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Agencia Nacional de Investigación y Desarrollo

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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 5, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 26, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 18, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 4, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 22, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

  1. 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/Y4SGJ
    Information comments: The analytic code and data will be uploaded once the data is collected (est. December, 2025) and analyzed (est. June, 2026)
  2. 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.

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