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Completed

NCT Number: NCT07654920

Development of Executive Functions in Children and Adolescents: Establishment of a Reference Norm for the Assessment of Executive Functions in Ecological Settings (eEFEe Tool)

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.

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Key information

Age range

7 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

LP3C - Université Rennes II

Rennes, 35043, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

eEFEe Ecological Assessment and Standardized Testing

Behavioral

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.

Primary outcomes

  1. Number of successful actions on ecological assessments of executive functions in children (eEFEe test)

    Time frame: "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
  2. Number of errors on ecological assessments of executive functions in children (eEFEe test)

    Time frame: "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
  3. Performance on ecological assessments of executive functions in children (eEFEe test)

    Time frame: '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
  4. Performance on ecological assessments of executive functions in children (eEFEe test)

    Time frame: '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

Secondary outcomes

  1. Correlation with social cognition assessments

    Time frame: At the end of the study, when all the data have been collected

    Relationship between eEFEe task performance and standardized social cognition tests

  2. Correlation with standardized cognitive assessments

    Time frame: At the end of the study, when all the data have been collected

    Relationship between eEFEe task performance and standardized cognitive tests

  3. Influence of sociodemographic factors

    Time frame: 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).

  4. Age-related performance differences

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape

Other

Registry information

Acronym: DFEE

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 17, 2026
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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