Clinical trial NCT06935656: Effectiveness of Three Executive Function Interventions on Direct and Far Transfer in Chilean School Children
Official title: Effectiveness of Three Executive Function Interventions on Direct and Far Transfer in Chilean School Children
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Executive Functions
Keywords: Executive functions
intervention
academic performance
Lead sponsor: University of Talca
Sponsor class: OTHER
Collaborators: name: Agencia Nacional de Investigación y Desarrollo
First posted: 2025-04-20
Enrollment: 240
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention 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.
Primary purpose: BASIC_SCIENCE

Brief 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. 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in working memory
timeFrame: From baseline to end of intervention at 12 weeks
measure: Change from baseline in inhibitory control
timeFrame: From baseline to end of intervention at 12 weeks
measure: Change from baseline in cognitive flexibility
timeFrame: From baseline to end of intervention at 12 weeks
Secondary outcomes:
measure: Change from baseline in literacy
timeFrame: From baseline to end of intervention at 12 weeks
measure: Change from baseline in math ability
timeFrame: From baseline to end of intervention at 12 weeks
Other outcomes:
Locations:
city: Talca
country: Chile
facility: University of Talca
state: Maule
Study officials:
References: