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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.

Studie Overzicht

Studietype

Ingrijpend

Inschrijving (Werkelijk)

144

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen

Accepteert gezonde vrijwilligers

Ja

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Fundamentele wetenschap
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of successful actions on ecological assessments of executive functions in children (eEFEe test)
Tijdsspanne: "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)
Tijdsspanne: "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)
Tijdsspanne: '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)
Tijdsspanne: '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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Correlation with social cognition assessments
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

6 februari 2024

Primaire voltooiing (Werkelijk)

2 december 2025

Studie voltooiing (Werkelijk)

12 december 2025

Studieregistratiedata

Eerst ingediend

18 februari 2026

Eerst ingediend dat voldeed aan de QC-criteria

12 juni 2026

Eerst geplaatst (Werkelijk)

17 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

17 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

12 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • 2023-A02174-41

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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