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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: December 2014

Interventions

  • Behavioral: Executive functions training
    • Daily training of executive functions via activities to develop auto-regulation, attention and memory.
  • Behavioral: Language skills training
    • Daily training of language skills via activities to develop phonological awareness and vocabulary.
  • Other: Regular school curriculum
    • Ministry of Education national school curriculum.

Arms, Groups and Cohorts

  • Experimental: Executive functions training
  • Experimental: Language skills training
  • Active Comparator: Regular school curriculum

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

Inclusion Criteria

  • Schools interested in the intervention program – Preschool children (4 to 6 years old) Exclusion Criteria:

  • Presence of any sensory impairment – Intellectual disability

Gender Eligibility: All

Minimum Age: 3 Years

Maximum Age: 6 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Sao Paulo
  • Collaborator
    • Fundação de Amparo à Pesquisa do Estado de São Paulo
  • Provider of Information About this Clinical Study
    • Principal Investigator: Guilherme Vanoni Polanczyk, Professor – University of Sao Paulo

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