Executive FunctionNCT02807831
A Randomized Clinical Trial Comparing Executive Function and Language Skills Training on School Readiness in Preschool Children
A study testing Executive functions training, Language skills training and Regular school curriculum in people with Executive Function and Language, run by University of Sao Paulo.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Executive Function, Language, Preschool Child
- What is being tested?
- Executive functions training, Language skills training and Regular school curriculum
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 582 participants
- Where
- No sites listed yet
- Study dates
- Feb 2014to Dec 2014
- 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 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Schools interested in the intervention program
- Preschool children (4 to 6 years old)
Who cannot join
- Presence of any sensory impairment
- Intellectual disability
About this study
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.
- Conditions
- Executive Function, Language, Preschool Child
- Being tested
- Executive functions training, Language skills training, Regular school curriculum
- Keywords
- Executive Function, Language, Preschool child, Development
- Medical subject headings
- Language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Executive functions trainingBehavioural
Daily training of executive functions via activities to develop auto-regulation, attention and memory.
Language skills trainingBehavioural
Daily training of language skills via activities to develop phonological awareness and vocabulary.
Regular school curriculumOther
Ministry of Education national school curriculum.
| Study group | Role | What they receive |
|---|---|---|
| Executive functions training | Experimental | Not described Receives: Behavioral: Executive functions training |
| Language skills training | Experimental | Not described Receives: Behavioral: Language skills training |
| Regular school curriculum | Active comparator | Not described Receives: Other: Regular school curriculum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in school readiness
Assessed with a 43 items questionnaire developed by the research staff.
Measured: Beginning of the school year (baseline) and at the end of the school year (post intervention, 7 to 8 months later)
Secondary outcomes (3)
Change in inhibitory control
Inhibitory control assessed via the Flanker e Simon (Dots task) tests.
Measured: Beginning of the school year (baseline) and at the end of the school year (post intervention, 7 to 8 months later)
Change in working memory
Working memory assessed via the neuropsychological Automated Working Memory Assessment (AWMA).
Measured: Beginning of the school year (baseline) and at the end of the school year (post intervention, 7 to 8 months later)
Change in oral language skills
Expressive language assessed via the Child Language Test - ABFW.
Measured: Beginning of the school year (baseline) and at the end of the school year (post intervention, 7 to 8 months later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2016 (estimated)
- Study startFeb 2014
- Primary completionDec 2014
- Study completionDec 2014
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 582 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Guilherme Vanoni Polanczyk, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02807831
- Sponsor's protocol ID
- 2012/51.624-1
- Status last verified
- Jun 2016
- First submitted
- 10 Jun 2016
- Last updated
- 21 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial Comparing Executive Function and Language Skills Training on School Readiness in Preschool Children
- ClinicalTrials.gov ID
- NCT02807831
- Acronym / sponsor ID
- 2012/51.624-1
- Conditions
- Executive Function, Language, Preschool Child
- Keywords
- Executive Function, Language, Preschool child, Development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 582 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Feb 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 21 Jun 2016 (estimated)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Executive functions training | Experimental | Behavioral: Executive functions training |
| Language skills training | Experimental | Behavioral: Language skills training |
| Regular school curriculum | Active comparator | Other: Regular school curriculum |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Schools interested in the intervention program
- Preschool children (4 to 6 years old)
Key exclusion criteria (2 listed)
- Presence of any sensory impairment
- Intellectual disability
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 |
|---|---|---|
| Executive functions trainingDaily training of executive functions via activities to develop auto-regulation, attention and memory. | Behavioural | Executive functions training |
| Language skills trainingDaily training of language skills via activities to develop phonological awareness and vocabulary. | Behavioural | Language skills training |
| Regular school curriculumMinistry of Education national school curriculum. | Other | Regular school curriculum |
Primary outcome
Change in school readiness
Time frame: Beginning of the school year (baseline) and at the end of the school year (post intervention, 7 to 8 months later)
Assessed with a 43 items questionnaire developed by the research staff.
3 secondary outcomes
Change in inhibitory control
Time frame: Beginning of the school year (baseline) and at the end of the school year (post intervention, 7 to 8 months later)
Change in working memory
Time frame: Beginning of the school year (baseline) and at the end of the school year (post intervention, 7 to 8 months later)
Change in oral language skills
Time frame: Beginning of the school year (baseline) and at the end of the school year (post intervention, 7 to 8 months later)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Executive functions training, Language skills training and Regular school curriculum in people with Executive Function and Language, run by University of Sao Paulo.
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: finished, as of the sponsor's last update on 21 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in school readiness (time frame: Beginning of the school year (baseline) and at the end of the school year (post intervention, 7 to 8 months later)). 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 21 Jun 2016.