A Randomized Clinical Trial Comparing Executive Function and Language Skills Training on School Readiness in Preschool Children

Study Overview
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Brief Summary
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Background: environmental influences in the first years of life have a great impact on adulthood. Adequate environmental stimulation in the first years of life positively influence cognitive, emotional and neurological development. Studies show that high quality education for 3 to 6 years old children are cost-effective for diverse outcomes, such as socioemotional and cognitive development, as well as school performance. However, it is not clear why specific types of interventions are most effective on school readiness, an important precursor of literacy status and later life outcomes. Objectives: adapt to the Brazilian context two well-known intervention programs: (1) executive functions training developed by Diamond, and (2) oral language skills based on the Nuffield Programme developed by Snowling and colleagues. Methods: a randomized controlled trial involving 720 children (4 to 5 years old) allocated to three groups: (1) adapted school curriculum focusing on executive functions training, (2) adapted school curriculum focusing on oral language skills training, and (3) regular school curriculum.

Official Title
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A Randomized Clinical Trial Comparing Executive Function and Language Skills Training on School Readiness in Preschool Children

Conditions
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Language, Executive Function, Preschool Child

Intervention / Treatment
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* Behavioral: Executive functions training
* Behavioral: Language skills training
* Other: Regular school curriculum


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Schools interested in the intervention program Preschool children (4 to 6 years old) Exclusion Criteria: Presence of any sensory impairment Intellectual disability

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Executive functions training<br> | Behavioral: Executive functions training<br>* Daily training of executive functions via activities to develop auto-regulation, attention and memory.<br>|
| Experimental: Language skills training<br> | Behavioral: Language skills training<br>* Daily training of language skills via activities to develop phonological awareness and vocabulary.<br>|
| Active Comparator: Regular school curriculum<br> | Other: Regular school curriculum<br>* Ministry of Education national school curriculum.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in school readiness | Assessed with a 43 items questionnaire developed by the research staff. | Beginning of the school year (baseline) and at the end of the school year (post intervention, 7 to 8 months later) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in inhibitory control | Inhibitory control assessed via the Flanker e Simon (Dots task) tests. | Beginning of the school year (baseline) and at the end of the school year (post intervention, 7 to 8 months later) | 
| Change in working memory | Working memory assessed via the neuropsychological Automated Working Memory Assessment (AWMA). | Beginning of the school year (baseline) and at the end of the school year (post intervention, 7 to 8 months later) | 
| Change in oral language skills | Expressive language assessed via the Child Language Test - ABFW. | Beginning of the school year (baseline) and at the end of the school year (post intervention, 7 to 8 months later) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Executive Function, Language, Preschool child, Development