Executive FunctionNCT03491488
Brain Games to Improve Executive Function in São Paulo, Brazil
A study testing Brain Games in people with Executive Function, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Executive Function
- What is being tested?
- Brain Games
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteBrazil
- Study dates
- 16 Apr 2018to 1 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 4 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- age 3 years, 0 days to 4 years, 364 days at baseline
- attending public creches and pre-schools São Paulo's Western region
Who cannot join
- children younger than 3 years or older than 4 years at baseline
- not attending public creches and pre-schools
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, 01246903
About this study
Official title: Brain Games: A Crèches-Based Early Intervention Program to Improve Children's Executive Function and Self Control Skills in São Paulo, Brazil
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.
Read the 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
- Being tested
- Brain Games
- Keywords
- executive function, Early childhood education, self regulation
- Medical subject headings
- Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain GamesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Brain Games |
| Control Group | No intervention | 300 children in the randomly selected creches classrooms receiving the regular Brazilian curriculum. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Endline assessements - after 12 months of intervention delivery, scheduled for April 2019
Secondary outcomes (1)
School readiness
School readiness will be assessed using the IDELA tool
Measured: Endline survey - after 12 months of intervention; scheduled for April 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2018
- Study start16 Apr 2018 (estimated)
- Primary completion1 Jun 2019 (estimated)
- Study completion1 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Executive FunctionStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial at 60 public crèches in São Paulo, Brazil
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Grand Challenges Canada, Fundação Maria Cecilia Souto Vidigal, Harvard University, Swiss Tropical & Public Health Institute
- Responsible party
- Principal investigator, Alexandra Brentani, University of Sao Paulo
- Investigators
- Alexandra Brentani, PhD, Principal investigator, USao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03491488
- Sponsor's protocol ID
- 1707-09236
- Status last verified
- Apr 2018
- First submitted
- 20 Mar 2018
- Last updated
- 9 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Intervention materials will be shared with the Government.
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Games: A Crèches-Based Early Intervention Program to Improve Children's Executive Function and Self Control Skills in São Paulo, Brazil
- ClinicalTrials.gov ID
- NCT03491488
- Acronym / sponsor ID
- 1707-09236
- Conditions
- Executive Function
- Keywords
- executive function, Early childhood education, self regulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Grand Challenges Canada, Fundação Maria Cecilia Souto Vidigal, Harvard University, Swiss Tropical & Public Health Institute
- Study start
- 16 Apr 2018 (estimated)
- Primary completion
- 1 Jun 2019 (estimated)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 9 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized controlled trial at 60 public crèches in São Paulo, Brazil
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Brain Games300 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. |
| Control Group | No intervention | –300 children in the randomly selected creches classrooms receiving the regular Brazilian curriculum. |
Who may qualify
- Ages
- 3 to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- age 3 years, 0 days to 4 years, 364 days at baseline
- attending public creches and pre-schools São Paulo's Western region
Key exclusion criteria (2 listed)
- children younger than 3 years or older than 4 years at baseline
- not attending public creches and pre-schools
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain GamesThe 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. | Other | Intervention Group |
Primary outcome
Child executive functions
Time frame: Endline assessements - after 12 months of intervention delivery, scheduled for April 2019
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.
1 secondary outcome
School readiness
Time frame: Endline survey - after 12 months of intervention; scheduled for April 2019
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2018.
- Individual participant dataSharing planned: Yes. Intervention materials will be shared with the Government.
Related trials for Executive Function
Not yet recruiting
Cognitive-Motor Training With the DextEgg in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
Recruiting
Virtual Reality in Rehabilitation of Executive Functions in Children With Mild or Moderate Traumatic Brain Injury
Traumatic Brain Injury
Recruiting
Neocortical Microarchitecture of Executive Function
Parkinson Disease
Active, not recruiting
Learning by Heart: The Effectiveness of an EF Training Program for Pre-schoolers With Critical CHD
Congenital Heart Disease, Executive Dysfunction
Recruiting
Acupuncture for ADHD: Acupoint Data Mining, Clinical Effectiveness, and Interviews to Explore Treatment Outcomes.
Acupuncture, ADHD - Attention Deficit Disorder With Hyperactivity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandra Brentani, PhD principal investigator
USao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain Games in people with Executive Function, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandra V Brentani, PhD (+551126618803, alexandra@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child executive functions (time frame: Endline assessements - after 12 months of intervention delivery, scheduled for April 2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2018.