Development of Executive Functions in Children and Adolescents: Establishment of a Reference Norm for the Assessment of Executive Functions in Ecological Settings (eEFEe Tool) (DFEE)
The aim of this interventional study is to develop a normative reference for the ecological assessment of executive functions in children and adolescents using the eEFEe tool.
Executive functions are high-level cognitive abilities that support planning, behavioral regulation, and problem solving in everyday life. Current neuropsychological tests often fail to reflect real-life functioning. The eEFEe tool was designed to assess these abilities through tasks that simulate daily situations.
The study will include healthy children and adolescents aged 7 to 18 years, enrolled in regular schools in France. Participants will complete the eEFEe ecological tasks, as well as standardized cognitive and social cognition assessments, and parents will provide sociodemographic information.
Results from this study will be used to establish reference norms for the eEFEe tool and to examine how executive function performance varies according to age, cognitive development, and sociodemographic factors. These normative data will later support the clinical use of the eEFEe tool to better identify executive difficulties in children and adolescents.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
-
Rennes, France, 35043
- LP3C - Université Rennes II
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
Accepte les volontaires sains
La description
Inclusion Criteria (Children/Adolescents):
- Aged 7 to 18 years 11 months
- Enrolled in regular schools in France since early primary education
- Assent provided by child/adolescent and consent by parents/legal guardians; or consent by participant if 18 years old
- Covered by the French national health insurance system
Inclusion Criteria (Parents/Legal Guardians):
- Provided written consent
- Have a child participating in the DFEE study
Exclusion Criteria (Children/Adolescents):
- Significant motor impairments preventing completion of the eEFEe assessment
Exclusion Criteria (Parents/Legal Guardians):
- Insufficient spoken French proficiency preventing collection of sociodemographic data
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: eEFEe Assessment - Children/Adolescents and Parents
Children/Adolescents (7-18 years): Complete standardized cognitive and social cognition assessments and the eEFEe ecological executive function tasks. The ecological assessment includes six real-life tasks adapted to age and is video-recorded for later scoring of successes, errors, and verbal/non-verbal behaviors. Parents/Legal Guardians: Complete a sociodemographic questionnaire and the BRIEF Parent Form to provide information on family, schooling, and child behavior related to executive functions. |
Children/Adolescents: Complete the eEFEe ecological executive function tasks (six daily-life tasks adapted to age) and standardized cognitive and social cognition tests (NEPSY-II, WISC-V/WAIS, Rey Figure, etc.). Sessions are video-recorded for later scoring. Parents/Legal Guardians: Complete a sociodemographic questionnaire and the BRIEF Parent Form to assess executive-related behaviors in daily life. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of successful actions on ecological assessments of executive functions in children (eEFEe test)
Délai: "eEFEe" visit : Between Day 0 and Day 60
|
The eEFEe consists of six everyday tasks, adapted for different age groups in line with clinical and educational practices in the field. Each task is divided into several steps. Each step is scored according to the level of completion. An overall success score is assigned to each task. A high score indicates that the task has been successfully completed, while a low score indicates partial completion or failure to complete the task. The tasks in question are:
|
"eEFEe" visit : Between Day 0 and Day 60
|
|
Number of errors on ecological assessments of executive functions in children (eEFEe test)
Délai: "eEFEe" visit : Between Day 0 and Day 60
|
Number of errors on the eEFEe test. The number of errors that occurred during the task is recorded. These are categorised into two types: action errors and behavioural errors. Action errors include omissions, incomplete actions, additional actions, sequencing errors and the identification of errors without correction. Behavioural errors include difficult decisions, dependency, failure to take advantage of assistance provided, lack of initiative, distractibility, lack of engagement with the environment, dangerous behaviour, inappropriate behaviour and interventions by the therapist. Test tasks :
|
"eEFEe" visit : Between Day 0 and Day 60
|
|
Performance on ecological assessments of executive functions in children (eEFEe test)
Délai: 'eEFEe' visit: between Day 0 and Day 60
|
administration time for each assessment on the eEFEe test. Test tasks :
|
'eEFEe' visit: between Day 0 and Day 60
|
|
Performance on ecological assessments of executive functions in children (eEFEe test)
Délai: 'eEFEe' visit: between Day 0 and Day 60
|
Assessment of task habituation For each task, the participant is asked whether they usually perform it in their daily life. They can answer either "yes" or "no." Test tasks :
|
'eEFEe' visit: between Day 0 and Day 60
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Correlation with social cognition assessments
Délai: At the end of the study, when all the data have been collected
|
Relationship between eEFEe task performance and standardized social cognition tests
|
At the end of the study, when all the data have been collected
|
|
Correlation with standardized cognitive assessments
Délai: At the end of the study, when all the data have been collected
|
Relationship between eEFEe task performance and standardized cognitive tests
|
At the end of the study, when all the data have been collected
|
|
Influence of sociodemographic factors
Délai: Baseline Visit : Day 0
|
Collection of sociodemographic data :
With the aim of correlating the results obtained on the eEFEe test with sociodemographic data (socio-professional category, parents' educational level, age, birth order and number of siblings, and family structure). Simple and adjusted linear regressions will be performed (Bravais-Pearson correlation). |
Baseline Visit : Day 0
|
|
Age-related performance differences
Délai: Baseline visit : Day 0
|
Collection of participants' age in order to assign them to an age category.
With the aim of comparing the results obtained with the eEFEe tool across age groups.
Means and medians of the scores obtained at the two evaluations will be compared using Student's t-tests or ANOVA when data follow a normal distribution, or using Wilcoxon and Kruskal-Wallis tests when normality is not met.
|
Baseline visit : Day 0
|
Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 2023-A02174-41
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .