| Registry | NCT06935656 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, factorial, masking: none, basic science |
| Enrollment | 192 (Actual) |
| Sponsor | University of Talca (Other); collaborators: Agencia Nacional de Investigación y Desarrollo |
| Conditions | Executive Functions |
| Interventions | Tablet-based executive function intervention, Traditional executive function intervention, Mixed executive function intervention (Other) |
| Dates | start 2025-05-05, primary completion 2025-11-26, completion 2025-12-18, first posted 2025-04-20, last updated 2025-12-22 |
| Locations | 5 sites in Chile |
Related Papers Related Patents Related Grants Related Experts
All trials for Executive Functions All trials of Tablet-based executive function intervention All trials of Traditional executive function intervention
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| 5-6 year old group | Experimental | Other: Tablet-based executive function intervention; Other: Traditional executive function intervention; Other: Mixed executive function intervention | 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. |
| 9-10 year old group | Experimental | Other: Tablet-based executive function intervention; Other: Traditional executive function intervention; Other: Mixed executive function intervention | 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. |
| 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. |
Sex: All, ages: 5 Years to 10 Years
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Municipal School 2 | Talca, Maule Region | Chile | |
| Municipal School 4 | Talca, Maule Region | Chile | |
| Municipal School 5 | Talca, Maule Region | Chile | |
| Municipal School 1 | Talca, Maule Region | Chile | |
| Municipal School 3 | Talca, Maule Region | Chile |