Executive FunctionsNCT06935656
Effectiveness of Three Executive Function Interventions on Direct and Far Transfer in Chilean School Children
A study testing Tablet-based executive function intervention, Traditional executive function intervention and Mixed executive function intervention in people with Executive Functions, run by University of Talca at 5 sites in Chile.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Executive Functions
- What is being tested?
- Tablet-based executive function intervention, Traditional executive function intervention and Mixed executive function intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 5 sitesChile
- Study dates
- 5 May 2025to 18 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Chile5 sites
Municipal School 2
Talca, Maule Region, 07762
Municipal School 4
Talca, Maule Region, 07762
Municipal School 5
Talca, Maule Region, 07762
Municipal School 1
Talca, Maule Region
Municipal School 3
Talca, Maule Region
About this study
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.
- Conditions
- Executive Functions
- Being tested
- Tablet-based executive function intervention, Traditional executive function intervention, Mixed executive function intervention
- Keywords
- Executive functions, intervention, academic performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tablet-based executive function interventionOther
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.
Traditional executive function interventionOther
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.
Mixed executive function interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 5-6 year old group | Experimental | 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. Receives: Other: Tablet-based executive function intervention; Other: Traditional executive function intervention; Other: Mixed executive function intervention |
| 9-10 year old group | Experimental | 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. Receives: Other: Tablet-based executive function intervention; Other: Traditional executive function intervention; Other: Mixed executive function intervention |
| 5-6 year old TAU group | No intervention | 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. |
| 9-10 year old TAU group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in working memory
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.
Measured: From baseline to end of intervention at 12 weeks
Change from baseline in inhibitory control
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.
Measured: From baseline to end of intervention at 12 weeks
Change from baseline in cognitive flexibility
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.
Measured: From baseline to end of intervention at 12 weeks
Secondary outcomes (2)
Change from baseline in literacy
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.
Measured: From baseline to end of intervention at 12 weeks
Change from baseline in math ability
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.
Measured: From baseline to end of intervention at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start5 May 2025
- Primary completion26 Nov 2025
- Study completion18 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Executive FunctionsStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- This cluster-randomized, between-subjects factorial study examines two independent variables: (1) intervention modality (digital, traditional, mixed, and control) and (2) age group (5-6, 9-10 years), forming a 4 × 2 design with eight groups. Four schools will be randomly assigned to one modality. All follow the same state curriculum and serve demographically similar urban children, ensuring baseline comparability. Within each school, both age groups will participate, allowing analysis of main and interaction effects. The intervention delivers the same EF program via digital, traditional, or mixed formats, while the control group receives no specialized EF training. Executive functions, literacy, and math will be measured pre- and post-intervention.
- Masking
- None (open label)
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Talca
- Sponsor type
- University, hospital or other
- Collaborators
- Agencia Nacional de Investigación y Desarrollo
- Responsible party
- Principal investigator, nicholas napolitano, University of Talca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06935656
- Sponsor's protocol ID
- 21231300
- Other IDs
- 45/2024
- Status last verified
- Dec 2025
- First submitted
- 4 Apr 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Napolitano N, Rojas-Barahona CA, Gaete J, Araya R. A comparison of three executive function interventions on direct and far transfer in Chilean school children: a cluster-randomized controlled protocol. BMC Psychol. 2025 Jul 4;13(1):730. doi: 10.1186/s40359-025-03075-3.
PubMed 40615866
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Three Executive Function Interventions on Direct and Far Transfer in Chilean School Children
- ClinicalTrials.gov ID
- NCT06935656
- Acronym / sponsor ID
- 21231300
- Conditions
- Executive Functions
- Keywords
- Executive functions, intervention, academic performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- University of TalcaUniversity, hospital or other
- Collaborators
- Agencia Nacional de Investigación y Desarrollo
- Study start
- 5 May 2025 (actual)
- Primary completion
- 26 Nov 2025 (actual)
- Study completion
- 18 Dec 2025 (actual)
- First posted
- 20 Apr 2025 (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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This cluster-randomized, between-subjects factorial study examines two independent variables: (1) intervention modality (digital, traditional, mixed, and control) and (2) age group (5-6, 9-10 years), forming a 4 × 2 design with eight groups. Four schools will be randomly assigned to one modality. All follow the same state curriculum and serve demographically similar urban children, ensuring baseline comparability. Within each school, both age groups will participate, allowing analysis of main and interaction effects. The intervention delivers the same EF program via digital, traditional, or mixed formats, while the control group receives no specialized EF training. Executive functions, literacy, and math will be measured pre- and post-intervention.
| Arm | Type | Receives |
|---|---|---|
| 5-6 year old group | Experimental | Other: Tablet-based executive function intervention, Other: Traditional executive function intervention, Other: Mixed executive function interventionThis 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. |
| 9-10 year old group | Experimental | Other: Tablet-based executive function intervention, Other: Traditional executive function intervention, Other: Mixed executive function interventionThis 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. |
| 5-6 year old TAU group | No intervention | –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. |
| 9-10 year old TAU group | No intervention | –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. |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| Tablet-based executive function interventionThis 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. | Other | 5-6 year old group, 9-10 year old group |
| Traditional executive function interventionThis 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 | 5-6 year old group, 9-10 year old group |
| Mixed executive function interventionThis 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 | 5-6 year old group, 9-10 year old group |
Primary outcome
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.
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.
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.
2 secondary outcomes
Change from baseline in literacy
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Derived from this study: PubMed 40615866Napolitano N, Rojas-Barahona CA, Gaete J, Araya R. A comparison of three executive function interventions on direct and far transfer in Chilean school children: a cluster-randomized controlled protocol. BMC Psychol. 2025 Jul 4;13(1):730. doi: 10.1186/s40359-025-03075-3.
- Study protocolLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tablet-based executive function intervention, Traditional executive function intervention and Mixed executive function intervention in people with Executive Functions, run by University of Talca at 5 sites in Chile.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in working memory (time frame: From baseline to end of intervention at 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06935656, which also lists 1 linked publication.
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 22 Dec 2025.