Brain Games to Improve Executive Function in São Paulo, Brazil

NCT ID: NCT03491488

Last Updated: 2018-04-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-16
• Study Completion Date: 2019-12-01

Brief Summary

A growing body of research has highlighted the critical importance of children's self-regulation and executive function skills for their school performance as well as for their later life outcomes. Starting around age three, children have a unique potential to improve these skills and establish positive behaviors that will support them in school and life.

This project will adapt, implement and evaluate the effectiveness of the Brain Games intervention package as a tool to improve children's self-regulation and executive function skills. Brain Games were developed as part of larger behavioral intervention package in the US, and are designed to build the fundamental self-regulation skills that children need to be successful in school as well as later in life. The Brain Games curriculum will be adapted to Brazil, and evaluated through a 12 month randomized controlled trial with 60 crèches in São Paulo to assess its impact on children's self-regulation and executive functioning skills.

Detailed Description

Even though Brazil has made major efforts to improve children's access to early childhood care and education, most of Brazil's (as well as other countries') early childhood programming focuses on care and early learning including early literacy and numeracy. Relatively little attention is currently given to the development of the non-academic self-regulation and executive function skills that have been shown to be critical for children's schooling as well as later life outcomes. The main idea of this project is to adapt Brain Games - an evidence-based, scalable intervention package developed for the US - to the Brazilian context, and to assess its impact on children's self-regulation and executive functioning skills through a randomized controlled trial.

The Brain Games package consists of a series of games and exercises designed for young children in classroom settings. Brain Games are a new, "kernelized" approach to intervention, with simple and discrete stand-alone activities that can be easily integrated into routine operations at crèches with a limited amount of training and supervision of center staff.

The proposed project embodies the principle of Integrated Innovation; the main scientific innovation is the development and validation of a new, kernelized executive functioning intervention package for Brazil. The intervention package will be designed for, and implemented through the public early childhood care section; from a social perspective, the main innovation is to increase the quality of care socially disadvantaged children obtained in public child care. From a business perspective, the intervention itself is sustainable and scalable, as its main elements have already been developed in the US, training is minimal, and material costs are low. Furthermore, the intervention consists of games that are easy and fun to play for children, and can be easily added to the existing curriculum. If the trial is successful, the intervention package could and likely would be rolled out at larger scale.

Conditions

Executive Function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Intervention Group

300 children in the randomly selected crèche classrooms receiving the Brain Games intervention.

The Brain Games intervention we propose in this project is designed to complement and improve current government efforts. Given the importance of executive functioning skills and the high plasticity around age three, early programs like the ones proposed here may be the most effective tool to reduce socioeconomic and intergenerational disparities, and thus nicely complement current social protection policies.

Group Type: EXPERIMENTAL

Brain Games

Intervention Type: OTHER

The Brain Games intervention package is used as a tool to improve children's self-regulation and executive function skills. Brain Games were developed as part of larger behavioral intervention package in the US, and are designed to build the fundamental self-regulation skills that children need to be successful in school as well as later in life. The games are designed to be played in the classroom between regular activities.

Control Group

300 children in the randomly selected creches classrooms receiving the regular Brazilian curriculum.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Brain Games

The Brain Games intervention package is used as a tool to improve children's self-regulation and executive function skills. Brain Games were developed as part of larger behavioral intervention package in the US, and are designed to build the fundamental self-regulation skills that children need to be successful in school as well as later in life. The games are designed to be played in the classroom between regular activities.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• age 3 years, 0 days to 4 years, 364 days at baseline
• attending public creches and pre-schools São Paulo's Western region

Exclusion Criteria

• children younger than 3 years or older than 4 years at baseline
• not attending public creches and pre-schools

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 4 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Grand Challenges Canada

OTHER

Sponsor Role: collaborator

Fundação Maria Cecília Souto Vidigal

UNKNOWN

Sponsor Role: collaborator

Harvard University

OTHER

Sponsor Role: collaborator

Swiss Tropical & Public Health Institute

OTHER

Sponsor Role: collaborator

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Alexandra Brentani

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexandra Brentani, PhD

Role: PRINCIPAL_INVESTIGATOR

USao Paulo

Locations

Faculdade de Medicina da Universidade de São Paulo

São Paulo, São Paulo, Brazil

Countries

Brazil

Central Contacts

Alexandra V Brentani, PhD

Role: CONTACT

alexandra@usp.br

+551126618803

Sandra Grisi, PhD

Role: CONTACT

sandra.grisi@hc.fm.usp.br

+551126618803

Other Identifiers

1707-09236

Identifier Type: -

Identifier Source: org_study_id