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Markers of Executive Attention Development in Preschoolers - Behavioral Measures in Various Populations (MEDiATE-PRV)

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ClinicalTrials.gov Identifier: NCT04831762
Recruitment Status : Recruiting
First Posted : April 5, 2021
Last Update Posted : March 9, 2022
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen

Study Description
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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.


Condition or disease Intervention/treatment
Attention Deficit Behavioral: Attention Network task (computerized) Behavioral: Head-toes-knees-schoulders Behavioral: Laby 5-12 Behavioral: M-ABC 2 Behavioral: Stroop animals

Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: MARQUEURS DE DEVELOPPEMENT DE L'ATTENTION EXECUTIVE CHEZ L'ENFANT : POPULATIONS VARIEES
Actual Study Start Date : March 1, 2021
Estimated Primary Completion Date : October 1, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Behavioral: Attention Network task (computerized)
    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.
    Other Name: Child ANT, flankers task
  • Behavioral: Head-toes-knees-schoulders
    Following motor commands such as touch your head when they are congruent or incongruent.
    Other Name: HTKS
  • Behavioral: Laby 5-12
    Test of motor planning using labyrinths
  • Behavioral: M-ABC 2
    Test of motor functions using various subtests of gross and fine motor function.
  • Behavioral: Stroop animals
    Stroop test for preK children using animals instead of words

Outcome Measures
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Primary Outcome Measures :
  1. ANT performance [ Time Frame: 48 to 71 months of age ]
    Reaction time in ms to ANT trials with a correct answer

  2. Tactile processing score [ Time Frame: 48 to 71 months of age ]
    Score to the sensory profile tactile subtest


Eligibility Criteria
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Ages Eligible for Study:   48 Months to 71 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Preschoolers 48 to 71 months of age.
Criteria

Inclusion Criteria:

  • Attending preschool
  • Parental informed consent

Exclusion Criteria:

- None

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04831762


Contacts
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Contact: Nadege Roche-Labarbe, PhD +33(0)649922568 nadege.roche@unicaen.fr

Locations
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France
Comete U1075 Inserm Unicaen Recruiting
Caen, France, 14032
Contact: Nadege Roche-Labarbe, PhD         
Sponsors and Collaborators
University Hospital, Caen
More Information
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Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT04831762    
Other Study ID Numbers: 2020-A03209-30
First Posted: April 5, 2021    Key Record Dates
Last Update Posted: March 9, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders