Brain Games to Improve Executive Function in São Paulo, Brazil

NCT03491488 | Unknown

• 1 other identifier: 1707-09236
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Executive Function

Keywords

executive function; Early childhood education; self regulation

Outcome Measures

Primary Outcomes (1)

• Child executive functions

  Child executive functions will be a composite score based on three tests conducted with all children at endline: a hearts-and-flowers test conducted on tablets, a pencil-tap test, and the IDELA executive functioning assessment. The composite score will be computed using principal component analysis of the normalized scores in the three tests.

  Endline assessements - after 12 months of intervention delivery, scheduled for April 2019

Secondary Outcomes (1)

• School readiness

  Endline survey - after 12 months of intervention; scheduled for April 2019

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Other: Brain Games

Control Group

NO INTERVENTION

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

Interventions

Brain Games 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.

Intervention Group

Eligibility Criteria

• Age: 3 Years - 4 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo: lead
• Grand Challenges Canada: collaborator
• Fundação Maria Cecília Souto Vidigal: collaborator
• Harvard University: collaborator
• Swiss Tropical & Public Health Institute: collaborator

Study Sites (1)

Faculdade de Medicina da Universidade de São Paulo

São Paulo, São Paulo, 01246903, Brazil

Location

MeSH Terms

Conditions

Self-Control

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• Alexandra Brentani, PhD

  USao Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandra V Brentani, PhD

CONTACT

+551126618803; alexandra@usp.br

Sandra Grisi, PhD

CONTACT

+551126618803; sandra.grisi@hc.fm.usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: randomized controlled trial at 60 public crèches in São Paulo, Brazil

Study Record Dates

• First Submitted: March 20, 2018
• First Posted: April 9, 2018
• Study Start: April 16, 2018
• Primary Completion: June 1, 2019
• Study Completion: December 1, 2019
• Last Updated: April 9, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)