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

• Sponsor: University Hospital, Caen (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04831762
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Anticipated Duration (Months): 34
• Patients Per Site Per Month: 5.9

Study Details

Study Description

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	Phase
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

• Study Type: Observational
• Anticipated 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: Mar 1, 2021
• Anticipated Primary Completion Date: Oct 1, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Outcome Measures

Primary Outcome Measures

1. ANT performance [48 to 71 months of age]

   Reaction time in ms to ANT trials with a correct answer

2. Tactile processing score [48 to 71 months of age]

   Score to the sensory profile tactile subtest

Eligibility Criteria

Criteria

• Ages Eligible for Study: 48 Months to 71 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Attending preschool

• Parental informed consent

Exclusion Criteria:

• None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Comete U1075 Inserm Unicaen	Caen		France	14032

Sponsors and Collaborators

• University Hospital, Caen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Caen
• ClinicalTrials.gov Identifier: NCT04831762
• Other Study ID Numbers: 2020-A03209-30
• First Posted: Apr 5, 2021
• Last Update Posted: Mar 9, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Attention Deficit Disorder with Hyperactivity

Study Results

No Results Posted as of Mar 9, 2022