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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03063411
Other study ID # 146958
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2017
Est. completion date July 31, 2018

Study information

Verified date November 2018
Source University of Sheffield
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 175
Est. completion date July 31, 2018
Est. primary completion date July 14, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 5 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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 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.

Locations

Country Name City State
United Kingdom The University of Sheffield Sheffield

Sponsors (2)

Lead Sponsor Collaborator
University of Sheffield University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Long-term change in mathematical reasoning as measured by the WIAT-II mathematical reasoning sub-test. One year post-training from baseline
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary Change in classroom engagement score as rated by teachers using the Classroom Engagement Scale (FitzPatrick & Pagani, 2012). Three months post-intervention from baseline and 1 year post-intervention from baseline.
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