Effectiveness of Three Executive Function Interventions on Direct and Far Transfer in Chilean School Children

NCT ID: NCT06935656

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-05

Study Completion Date

2025-12-18

Brief Summary

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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.

Detailed Description

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Conditions

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Executive Functions

Keywords

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Executive functions intervention academic performance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Tablet-based executive function intervention

Intervention Type OTHER

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 intervention

Intervention Type OTHER

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 intervention

Intervention Type OTHER

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.

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.

Group Type EXPERIMENTAL

Tablet-based executive function intervention

Intervention Type OTHER

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 intervention

Intervention Type OTHER

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 intervention

Intervention Type OTHER

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Agencia Nacional de Investigación y Desarrollo

OTHER

Sponsor Role collaborator

University of Talca

OTHER

Sponsor Role lead

Responsible Party

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nicholas napolitano

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Municipal School 2

Talca, Maule Region, Chile

Site Status

Municipal School 4

Talca, Maule Region, Chile

Site Status

Municipal School 5

Talca, Maule Region, Chile

Site Status

Municipal School 1

Talca, Maule Region, Chile

Site Status

Municipal School 3

Talca, Maule Region, Chile

Site Status

Countries

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Chile

References

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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.

Reference Type DERIVED
PMID: 40615866 (View on PubMed)

Study Documents

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Document Type: All of the information regarding the Consent forms, IRB certificate as well as the analytic code and data can be found here.

View Document

Document Type: Study Protocol

View Document

Related Links

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https://osf.io/9mp83

Study protocol

Other Identifiers

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45/2024

Identifier Type: OTHER

Identifier Source: secondary_id

21231300

Identifier Type: -

Identifier Source: org_study_id