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

NCT02807831 | Completed

• 1 other identifier: 2012/51.624-1
• Study Type: interventional
• Target: 582
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Executive Function; Language; Preschool Child

Keywords

Executive Function; Language; Preschool child; Development

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in inhibitory control

  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

  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

  Beginning of the school year (baseline) and at the end of the school year (post intervention, 7 to 8 months later)

Study Arms (3)

Executive functions training

EXPERIMENTAL

Behavioral: Executive functions training

Language skills training

EXPERIMENTAL

Behavioral: Language skills training

Regular school curriculum

ACTIVE COMPARATOR

Other: Regular school curriculum

Interventions

Executive functions training BEHAVIORAL

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

Executive functions training

Language skills training BEHAVIORAL

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

Language skills training

Regular school curriculum OTHER

Ministry of Education national school curriculum.

Regular school curriculum

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Presence of any sensory impairment
• Intellectual disability

Sponsors & Collaborators

• University of Sao Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

MeSH Terms

Conditions

Language

Condition Hierarchy (Ancestors)

Communication; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 10, 2016
• First Posted: June 21, 2016
• Study Start: February 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: June 21, 2016

Record last verified: 2016-06