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

University of Talca

Status: Completed

Conditions: Executive Functions

Treatments: Other: Traditional executive function intervention; Other: Mixed executive function intervention; Other: Tablet-based executive function intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06935656

45/2024 (Other Identifier)

21231300

Details and patient eligibility

About

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.

Enrollment: 192 patients

Sex: All

Ages: 5 to 10 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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192 participants in 4 patient groups

5-6 year old group

Experimental group

Description:

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.

Treatment:

Other: Tablet-based executive function intervention

Other: Mixed executive function intervention

Other: Traditional executive function intervention

9-10 year old group

Experimental group

Description:

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.

Treatment:

Other: Tablet-based executive function intervention

Other: Mixed executive function intervention

Other: Traditional executive function intervention

5-6 year old TAU group

No Intervention group

Description:

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 group

Description:

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.