Skip to main content
OpenTrials
Completed

NCT Number: NCT02807831

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Presence of any sensory impairment
  • Intellectual disability

Treatment and study plan

Executive functions training

Behavioral

Daily training of executive functions via activities to develop auto-regulation, attention and memory.

Language skills training

Behavioral

Daily training of language skills via activities to develop phonological awareness and vocabulary.

Regular school curriculum

Other

Ministry of Education national school curriculum.

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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).

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 21, 2016
Registry last updated
Jun 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.