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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
175

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United Kingdom
      • Sheffield, United Kingdom
        • The University of Sheffield

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Executive Function Intervention
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.
Other: Active Control Group
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
The investigators will use the Wechsler Individual Achievement Test-II to measure this (WIAT-II; Wechsler, 2005).
Baseline = one week before the intervention; post-test = one week post-intervention, three months post-intervention.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
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.
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.
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.
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.
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.
Three months post-intervention from baseline and 1 year post-intervention from baseline.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Sheffield

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Nottingham

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 14, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 10, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 24, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 6, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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