Clinical trial NCT03491488: Brain Games to Improve Executive Function in São Paulo, Brazil
Official title: Brain Games: A Crèches-Based Early Intervention Program to Improve Children's Executive Function and Self Control Skills in São Paulo, Brazil
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Executive Function
Keywords: executive function
Early childhood education
self regulation
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Grand Challenges Canada
name: Fundação Maria Cecília Souto Vidigal
name: Harvard University
name: Swiss Tropical & Public Health Institute
First posted: 2018-04-09
Enrollment: 600
Sex: ALL
Minimum age (years): 3
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial at 60 public crèches in São Paulo, Brazil
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Child executive functions
timeFrame: Endline assessements - after 12 months of intervention delivery, scheduled for April 2019
Secondary outcomes:
measure: School readiness
timeFrame: Endline survey - after 12 months of intervention; scheduled for April 2019
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Faculdade de Medicina da Universidade de São Paulo
state: SP
Study officials:
affiliation: USao Paulo
name: Alexandra Brentani, PhD
role: PRINCIPAL_INVESTIGATOR
References: