Clinical trial NCT05472194: Promoting Inclusive Education Through Executive Functions
Official title: Promoting Inclusive Education Through Executive Functions - Study Protocol of a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cognitive Training
Keywords: Inclusive Education
Executive Functions
Cognitive Tools
Lead sponsor: University of Minho
Sponsor class: OTHER
First posted: 2022-07-25
Enrollment: 470
Sex: ALL
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The protocol includes a randomized controlled trial with a follow-up at six months involving two groups per age range (5,6 and 7Y) -a training group, which will be enrolled in the InSchool program and an active control group that will be participating in the regular kindergarten/elementary school activities. Participants will be randomly assigned to each group to control for inter-individual variability in executive functions' developmental level, which could distinctly impact the study results.
Primary purpose: PREVENTION

Brief summary: Background: Recently governments worldwide have been doing enormous efforts to ensuring egalitarian educational opportunities for all children. However, the number of children that remain out of the school or lack proficiency in academic performance is still very worrying. One of the factors that seems to contribute to such inequalities is socioeconomic status (SES). SES strongly impacts the developmental trajectory of both the brain and cognitive abilities as off early childhood, further affecting learning and academic success.

Despite the great interest in building inclusive societies and the promising results of executive functions' training programs for leveling the SES-achievement disparities, only a few studies have actually included schools from low-SES settings and lack a comprehensive, evidence-based background underlying the intervention protocols. Thus, with a preventive emphasis, the current project aims to implementing and evaluating a cost-effective game-based training protocol to promote and boost the development of executive functions in preschool and elementary school-aged children from disadvantaged contexts, ultimately contributing to prevent school dropout and reduce academic inequalities.

Detailed description: A randomized controlled trial will be implemented in Portuguese schools embedded in low-income settings. It will include a total of 396 participants, 132 per age group: 5,6 and 7 years old. At each age group a total of 132 children will be enrolled in the program for 4 weeks, 66 in the active control group, and 66 in the intervention group. The assessment protocol will include demographics, including SES, and evaluation of executive functions. Both groups -control and intervention- will complete the same assessment protocol at three distinct moments -baseline, post-intervention, and 6 months' follow-up. The training program will comprise the following: (i) 3 weekly sessions of 30 minutes each (ii) each session will be dedicated to train a specific domain of executive functions -working memory, inhibition and cognitive flexibility.

Eligibility criteria: Inclusion Criteria:

* Typically developed children of 5, 6, and 7 years old attending the regular curriculum at public educational services -kindergarten and elementary school.

Exclusion Criteria:

* Presence or history of cognitive deficits, neurological or psychiatric condition.

Primary outcomes:
measure: Executive functions (Working memory)
timeFrame: Through study completion, an average of 1 year.
measure: Executive functions (Working memory)
timeFrame: Through study completion, an average of 1 year.
measure: Executive functions (Inhibitory control)
timeFrame: Through study completion, an average of 1 year.
measure: Executive functions (Inhibitory control)
timeFrame: Through study completion, an average of 1 year.
measure: Executive functions (set shifting)
timeFrame: Through study completion, an average of 1 year.
measure: Executive functions (set shifting)
timeFrame: Through study completion, an average of 1 year.
Secondary outcomes:
measure: School Grades
timeFrame: Through study completion, an average of 1 year.
Other outcomes:
Locations:
Study officials:
affiliation: School of Psychology, University of Minho
name: Sónia Sousa, PhD
role: PRINCIPAL_INVESTIGATOR
References: