Cognitive DevelopmentNCT03063411
Testing Whether a Short Training Program Designed to Improve Cognitive Skills Improves 4-year-olds' Maths Skills
A study testing Executive Function Intervention in people with Cognitive Development, run by University of Sheffield at 1 site in United Kingdom.
Trial summary
This study will test whether a short training program - designed to improve memory and attention skills - will benefit mathematical reasoning in preschoolers from a range of socio-economic backgrounds. Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Development
- What is being tested?
- Executive Function Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2017to 31 Jul 2018
- 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 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Must be attending a nursery school attached to a primary school.
- Must speak and understand English (class teachers will advise on this).
- Must have at least one measure of working memory completed at baseline and one measure of inhibitory control completed at baseline.
Who cannot join
- Must not have a significant diagnosed or known physical, mental or learning disability.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Testing a Short Executive Function Training Intervention to Improve Mathematical Reasoning in a Diverse Sample of Children Before They Start School
This study will test whether a short training program - designed to improve memory and attention skills - will benefit mathematical reasoning in preschoolers from a range of socio-economic backgrounds. The investigators will test how long any benefits last for and whether any intervention effects are greater for children from disadvantaged backgrounds. The aim is to test interventions that aim to close the achievement gap by improving skills known to underpin academic skills, at an age children may benefit most from training.
Read the detailed description
Children's academic success across a range of domains is related to their executive function skills - specifically by their ability to maintain and update information (working memory) and to suppress inappropriate responses (inhibitory control). These skills undergo significant development during the preschool years. Notably, preschool executive function skills strongly predict school readiness, as well as concurrent and later academic achievements in mathematics. The aim of this project is to test an intervention that is specifically designed to improve preschoolers' executive functions - crucially, before the achievement gap sets in. The study will be carried out, following CONSORT (2010) guidelines, with typically developing preschoolers (aged approximately 4 years of age). The study will include children from socioeconomically advantaged and disadvantaged families. Children will be randomly assigned to either an executive function training group or an active control group. A nominated person external to the project will conduct the random allocation process. The random allocation will be done for each nursery to ensure roughly even numbers in each group from each nursery. Children in both groups will complete computerized tasks lasting 15-20 minutes once a week for four weeks. The investigators will compare the trained children to an active control group that closely matches the training in terms of activity. To check for improvements, the investigators will measure cognitive and maths skills at baseline (one week before training); one week post-training; three months post-training; and one year post-training. These assessments will be conducted by testers blind to the child's group.
- Conditions
- Cognitive Development
- Being tested
- Executive Function Intervention, Active Control Group
- Keywords
- Maths reasoning, Working memory, Executive Functions, Cognitive Control, Academic Skills, Randomised Control Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Executive Function InterventionOther
In the executive function training group, children will complete computerised tasks requiring working memory and inhibitory control over four weekly sessions lasting 15-20 minutes. The aim is to improve their executive function skills. In the active control group, children will complete computerised tasks requiring simple decision making and visual search skills over four weekly sessions lasting 15-20 minutes.
Active Control GroupOther
This is the active control condition. Children will complete computerised tasks requiring simple decision making and visual search skills over four weekly sessions lasting 15-20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Executive function intervention | Experimental | The intervention comprises four weekly sessions lasting 15-20 minutes. In these sessions, children complete computerised tasks requiring working memory and inhibitory control. These tasks are child friendly and are based on established measures of executive function. The working memory tasks involve maintaining information in mind and processing information (for example, finding items hiding in different locations that move around) and suppressing a dominant but incorrect response (for example, a game where children try to catch fish but not sharks). Children receive feedback on their responses. If children score 75% or more correct in a session the difficulty level increases in the following session. Receives: Other: Executive Function Intervention |
| Visual search and simple decision making | Active comparator | The control task program, like the intervention, comprises four weekly sessions lasting 15-20 minutes. In these sessions, children complete computerised tasks not requiring executive function skills. Instead, they require simple attention and decision making skills and visual search skills. For example, finding an item among distractors (e.g., a spaceship), or deciding which of two animals can fly (out of a bird and a fish). Children receive feedback on their responses. Receives: Other: Active Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mathematical reasoning scores as measured by the WIAT-II mathematical reasoning sub-test.
The investigators will use the Wechsler Individual Achievement Test-II to measure this (WIAT-II; Wechsler, 2005).
Measured: Baseline = one week before the intervention; post-test = one week post-intervention, three months post-intervention.
Secondary outcomes (6)
Long-term change in mathematical reasoning as measured by the WIAT-II mathematical reasoning sub-test.
Measured: One year post-training from baseline
Change in verbal working memory as measured by the Backward Word Span task.
Measured: One week post-intervention from baseline, three months post-intervention from baseline and 1 year post-intervention from baseline.
Change in visuo-spatial working memory as measured by the Corsi Block task.
Measured: One week post-intervention from baseline, three months post-intervention from baseline and 1 year post-intervention from baseline.
Change in in inhibitory control as measured by the Grass/Snow task.
Measured: One week post-intervention from baseline, three months post-intervention from baseline and 1 year post-intervention from baseline.
Change in in inhibitory control as measured by the Peg Tapping task.
Measured: One week post-intervention from baseline, three months post-intervention from baseline and 1 year post-intervention from baseline.
Change in classroom engagement score as rated by teachers using the Classroom Engagement Scale (FitzPatrick & Pagani, 2012).
Measured: Three months post-intervention from baseline and 1 year post-intervention from baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2017
- Study start1 Feb 2017
- Primary completion14 Jul 2017
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DevelopmentStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sheffield
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nottingham
- Responsible party
- Principal investigator, Emma Blakey, University of Sheffield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03063411
- Sponsor's protocol ID
- 146958
- Status last verified
- Nov 2018
- First submitted
- 10 Feb 2017
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing a Short Executive Function Training Intervention to Improve Mathematical Reasoning in a Diverse Sample of Children Before They Start School
- ClinicalTrials.gov ID
- NCT03063411
- Acronym / sponsor ID
- 146958
- Conditions
- Cognitive Development
- Keywords
- Maths reasoning, Working memory, Executive Functions, Cognitive Control, Academic Skills, Randomised Control Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- University of SheffieldUniversity, hospital or other
- Collaborators
- University of Nottingham
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 14 Jul 2017 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 24 Feb 2017 (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.
This study will test whether a short training program - designed to improve memory and attention skills - will benefit mathematical reasoning in preschoolers from a range of socio-economic backgrounds. The investigators will test how long any benefits last for and whether any intervention effects are greater for children from disadvantaged backgrounds. The aim is to test interventions that aim to close the achievement gap by improving skills known to underpin academic skills, at an age children may benefit most from training.
Detailed description
Children's academic success across a range of domains is related to their executive function skills - specifically by their ability to maintain and update information (working memory) and to suppress inappropriate responses (inhibitory control). These skills undergo significant development during the preschool years. Notably, preschool executive function skills strongly predict school readiness, as well as concurrent and later academic achievements in mathematics. The aim of this project is to test an intervention that is specifically designed to improve preschoolers' executive functions - crucially, before the achievement gap sets in. The study will be carried out, following CONSORT (2010) guidelines, with typically developing preschoolers (aged approximately 4 years of age). The study will include children from socioeconomically advantaged and disadvantaged families. Children will be randomly assigned to either an executive function training group or an active control group. A nominated person external to the project will conduct the random allocation process. The random allocation will be done for each nursery to ensure roughly even numbers in each group from each nursery. Children in both groups will complete computerized tasks lasting 15-20 minutes once a week for four weeks. The investigators will compare the trained children to an active control group that closely matches the training in terms of activity. To check for improvements, the investigators will measure cognitive and maths skills at baseline (one week before training); one week post-training; three months post-training; and one year post-training. These assessments will be conducted by testers blind to the child's group.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Executive function intervention | Experimental | Other: Executive Function InterventionThe intervention comprises four weekly sessions lasting 15-20 minutes. In these sessions, children complete computerised tasks requiring working memory and inhibitory control. These tasks are child friendly and are based on established measures of executive function. The working memory tasks involve maintaining information in mind and processing information (for example, finding items hiding in different locations that move around) and suppressing a dominant but incorrect response (for example, a game where children try to catch fish but not sharks). Children receive feedback on their responses. If children score 75% or more correct in a session the difficulty level increases in the following session. |
| Visual search and simple decision making | Active comparator | Other: Active Control GroupThe control task program, like the intervention, comprises four weekly sessions lasting 15-20 minutes. In these sessions, children complete computerised tasks not requiring executive function skills. Instead, they require simple attention and decision making skills and visual search skills. For example, finding an item among distractors (e.g., a spaceship), or deciding which of two animals can fly (out of a bird and a fish). Children receive feedback on their responses. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Must be attending a nursery school attached to a primary school.
- Must speak and understand English (class teachers will advise on this).
- Must have at least one measure of working memory completed at baseline and one measure of inhibitory control completed at baseline.
Key exclusion criteria (1 listed)
- Must not have a significant diagnosed or known physical, mental or learning 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 Function InterventionIn the executive function training group, children will complete computerised tasks requiring working memory and inhibitory control over four weekly sessions lasting 15-20 minutes. The aim is to improve their executive function skills. In the active control group, children will complete computerised tasks requiring simple decision making and visual search skills over four weekly sessions lasting 15-20 minutes. | Other | Executive function intervention |
| Active Control GroupThis is the active control condition. Children will complete computerised tasks requiring simple decision making and visual search skills over four weekly sessions lasting 15-20 minutes. | Other | Visual search and simple decision making |
Primary outcome
Change in mathematical reasoning scores as measured by the WIAT-II mathematical reasoning sub-test.
Time frame: Baseline = one week before the intervention; post-test = one week post-intervention, three months post-intervention.
The investigators will use the Wechsler Individual Achievement Test-II to measure this (WIAT-II; Wechsler, 2005).
6 secondary outcomes
Long-term change in mathematical reasoning as measured by the WIAT-II mathematical reasoning sub-test.
Time frame: One year post-training from baseline
Change in verbal working memory as measured by the Backward Word Span task.
Time frame: One week post-intervention from baseline, three months post-intervention from baseline and 1 year post-intervention from baseline.
Change in visuo-spatial working memory as measured by the Corsi Block task.
Time frame: One week post-intervention from baseline, three months post-intervention from baseline and 1 year post-intervention from baseline.
Change in in inhibitory control as measured by the Grass/Snow task.
Time frame: One week post-intervention from baseline, three months post-intervention from baseline and 1 year post-intervention from baseline.
Change in in inhibitory control as measured by the Peg Tapping task.
Time frame: One week post-intervention from baseline, three months post-intervention from baseline and 1 year post-intervention from baseline.
Change in classroom engagement score as rated by teachers using the Classroom Engagement Scale (FitzPatrick & Pagani, 2012).
Time frame: Three months post-intervention from baseline and 1 year post-intervention from baseline.
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 6 Nov 2018.
- Our Funder: The Nuffield FoundationLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Executive Function Intervention in people with Cognitive Development, run by University of Sheffield at 1 site in United Kingdom.
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 3 inclusion and 1 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 6 Nov 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 United Kingdom. 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?
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 mathematical reasoning scores as measured by the WIAT-II mathematical reasoning sub-test. (time frame: Baseline = one week before the intervention; post-test = one week post-intervention, three months post-intervention.). 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 6 Nov 2018.