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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.

Panoramica dello studio

Tipo di studio

Interventistico

Iscrizione (Effettivo)

144

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

      • Rennes, Francia, 35043
        • LP3C - Université Rennes II

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto

Accetta volontari sani

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Scienza basilare
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of successful actions on ecological assessments of executive functions in children (eEFEe test)
Lasso di tempo: "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:

  • Document sorting
  • Board game
  • Swimming bag and school bag
  • Vidéo game
  • Cooking
  • DIY
"eEFEe" visit : Between Day 0 and Day 60
Number of errors on ecological assessments of executive functions in children (eEFEe test)
Lasso di tempo: "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 :

  • Document sorting
  • Board game
  • Swimming bag and school bag
  • Vidéo game
  • Cooking
  • DIY
"eEFEe" visit : Between Day 0 and Day 60
Performance on ecological assessments of executive functions in children (eEFEe test)
Lasso di tempo: 'eEFEe' visit: between Day 0 and Day 60

administration time for each assessment on the eEFEe test.

Test tasks :

  • Document sorting
  • Board game
  • Swimming bag and school bag
  • Vidéo game
  • Cooking
  • DIY
'eEFEe' visit: between Day 0 and Day 60
Performance on ecological assessments of executive functions in children (eEFEe test)
Lasso di tempo: '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 :

  • Document sorting
  • Board game
  • Swimming bag and school bag
  • Vidéo game
  • Cooking
  • DIY
'eEFEe' visit: between Day 0 and Day 60

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Correlation with social cognition assessments
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline Visit : Day 0

Collection of sociodemographic data :

  • Socio-professional category
  • Parents' educational level
  • Child's age
  • Birth order and sibling size
  • Family structure

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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

6 febbraio 2024

Completamento primario (Effettivo)

2 dicembre 2025

Completamento dello studio (Effettivo)

12 dicembre 2025

Date di iscrizione allo studio

Primo inviato

18 febbraio 2026

Primo inviato che soddisfa i criteri di controllo qualità

12 giugno 2026

Primo Inserito (Effettivo)

17 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

17 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

12 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 2023-A02174-41

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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