- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03063411
Testing Whether a Short Training Program Designed to Improve Cognitive Skills Improves 4-year-olds' Maths Skills
November 5, 2018 updated by: Emma Blakey, University of Sheffield
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
175
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Sheffield, United Kingdom
- The University of Sheffield
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 5 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion criteria:
- 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.
Exclusion criteria:
- Must not have a significant diagnosed or known physical, mental or learning disability.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Executive function intervention
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.
|
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 Comparator: Visual search and simple decision making
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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The investigators will use the Wechsler Individual Achievement Test-II to measure this (WIAT-II; Wechsler, 2005).
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Baseline = one week before the intervention; post-test = one week post-intervention, three months post-intervention.
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Long-term change in mathematical reasoning as measured by the WIAT-II mathematical reasoning sub-test.
Time Frame: One year post-training from baseline
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One year post-training from baseline
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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.
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One week post-intervention from baseline, three months post-intervention from baseline and 1 year post-intervention from baseline.
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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.
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One week post-intervention from baseline, three months post-intervention from baseline and 1 year post-intervention from baseline.
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|
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.
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One week post-intervention from baseline, three months post-intervention from baseline and 1 year post-intervention from baseline.
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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.
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One week post-intervention from baseline, three months post-intervention from baseline and 1 year post-intervention from baseline.
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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.
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Three months post-intervention from baseline and 1 year post-intervention from baseline.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2017
Primary Completion (Actual)
July 14, 2017
Study Completion (Actual)
July 31, 2018
Study Registration Dates
First Submitted
February 10, 2017
First Submitted That Met QC Criteria
February 20, 2017
First Posted (Actual)
February 24, 2017
Study Record Updates
Last Update Posted (Actual)
November 6, 2018
Last Update Submitted That Met QC Criteria
November 5, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 146958
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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