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

Executive Function Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02807831
• Other study ID #: 2012/51.624-1
• Status: Completed
• Phase: N/A
• First received: June 10, 2016
• Last updated: June 16, 2016
• Start date: February 2014
• Est. completion date: December 2014

Study information

• Verified date: June 2016
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 582
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 6 Years

Eligibility

Inclusion Criteria:

• Schools interested in the intervention program

• Preschool children (4 to 6 years old)

Exclusion Criteria:

• Presence of any sensory impairment

• Intellectual disability

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Executive Function
• Language
• Preschool Child

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Secondary	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)	Yes
Secondary	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)	Yes
Secondary	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)	Yes