NCT04831762

Brief Summary

Executive attention is essential for emotional and behavioral self-regulation. There is inter-individual variability in the level of efficiency of executive attention from kindergarten entry, and this variability predicts children's academic performance at entry to elementary school and beyond. It is therefore essential to better understand the early stages of executive attention development and self-regulation from an early age in order to develop tools for early detection of executive attention disorders, so that school accommodations can be proposed as early as possible. In previous work, we have identified early tactile information processing skills that underpin the development of executive attention. We would like to extend this work to a diverse population of preschool children, in order to consider new tools for the early detection of attention disorders. The MEDiATE-PRV project aims to compare the performance obtained in a validated attentional task in preschool children with assessments of tactile information processing, in relation to the psychomotor and executive development of the child. We will include 200 children aged 4 years to 5 years 11 months with different risk factors for ADHD.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 2, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 5, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

March 9, 2022

Status Verified

March 1, 2022

Enrollment Period

2.6 years

First QC Date

April 2, 2021

Last Update Submit

March 8, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • ANT performance

    Reaction time in ms to ANT trials with a correct answer

    48 to 71 months of age

  • Tactile processing score

    Score to the sensory profile tactile subtest

    48 to 71 months of age

Interventions

Computer-based game challenging orienting and executive attention. The subject must chose which side an animal is going, using left and right buttons, depending on the validity of a cue and the congruency of flankers.

Also known as: Child ANT, flankers task

Following motor commands such as touch your head when they are congruent or incongruent.

Also known as: HTKS
Laby 5-12BEHAVIORAL

Test of motor planning using labyrinths

M-ABC 2BEHAVIORAL

Test of motor functions using various subtests of gross and fine motor function.

Stroop animalsBEHAVIORAL

Stroop test for preK children using animals instead of words

Eligibility Criteria

Age48 Months - 71 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Preschoolers 48 to 71 months of age.

You may qualify if:

  • Attending preschool
  • Parental informed consent

You may not qualify if:

  • \- None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Comete U1075 Inserm Unicaen

Caen, 14032, France

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Central Study Contacts

Nadege Roche-Labarbe, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2021

First Posted

April 5, 2021

Study Start

March 1, 2021

Primary Completion

October 1, 2023

Study Completion

December 31, 2023

Last Updated

March 9, 2022

Record last verified: 2022-03

Locations