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

NCT ID: NCT02807831

Last Updated: 2016-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

582 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2014-12-31

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.

Detailed Description

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Conditions

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Executive Function Language Preschool Child

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Executive functions training

Group Type EXPERIMENTAL

Executive functions training

Intervention Type BEHAVIORAL

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

Language skills training

Group Type EXPERIMENTAL

Language skills training

Intervention Type BEHAVIORAL

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

Regular school curriculum

Group Type ACTIVE_COMPARATOR

Regular school curriculum

Intervention Type OTHER

Ministry of Education national school curriculum.

Interventions

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Executive functions training

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

Intervention Type BEHAVIORAL

Language skills training

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

Intervention Type BEHAVIORAL

Regular school curriculum

Ministry of Education national school curriculum.

Intervention Type OTHER

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
Minimum Eligible Age

3 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Guilherme Vanoni Polanczyk

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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2012/51.624-1

Identifier Type: -

Identifier Source: org_study_id

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