NCT03063411

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
175

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

February 10, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 24, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 14, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2018

Completed
Last Updated

November 6, 2018

Status Verified

November 1, 2018

Enrollment Period

5 months

First QC Date

February 10, 2017

Last Update Submit

November 5, 2018

Conditions

Keywords

Maths reasoningWorking memoryExecutive FunctionsCognitive ControlAcademic SkillsRandomised Control Trial

Outcome Measures

Primary Outcomes (1)

  • 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).

    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.

    One year post-training from baseline

  • Change in verbal working memory as measured by the Backward Word Span task.

    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.

    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.

    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.

    One week post-intervention from baseline, three months post-intervention from baseline and 1 year post-intervention from baseline.

  • +1 more secondary outcomes

Study Arms (2)

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.

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.

Other: Active Control Group

Interventions

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.

Executive function intervention

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.

Visual search and simple decision making

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Must not have a significant diagnosed or known physical, mental or learning disability.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Sheffield

Sheffield, United Kingdom

Location

Related Links

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

February 10, 2017

First Posted

February 24, 2017

Study Start

February 1, 2017

Primary Completion

July 14, 2017

Study Completion

July 31, 2018

Last Updated

November 6, 2018

Record last verified: 2018-11

Locations