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Executive Functions (EF)DFEENCT07654920

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

A study testing eEFEe Ecological Assessment and Standardized Testing in people with Executive Functions (EF) and Cognitive Development, run by Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 7 to 18 yearsHealthy volunteers can take part
What is being tested?
eEFEe Ecological Assessment and Standardized Testing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
144 participants
Where
1 siteFrance
Study dates
6 Feb 2024to 12 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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
  • Provided written consent
  • Have a child participating in the DFEE study

Who cannot join

  • Significant motor impairments preventing completion of the eEFEe assessment
  • Insufficient spoken French proficiency preventing collection of sociodemographic data

Trial locations and contacts

1 site in 1 country.

France1 site
  • LP3C - Université Rennes II

    Rennes, 35043

Other trials in France

About this study

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.

Read more

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.

Being tested
eEFEe Ecological Assessment and Standardized Testing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • eEFEe Ecological Assessment and Standardized TestingBehavioural

    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.

Study groups in NCT07654920
Study groupRoleWhat they receive
eEFEe Assessment - Children/Adolescents and ParentsExperimentalChildren/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.
Receives: Behavioral: eEFEe Ecological Assessment and Standardized Testing

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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

    Measured: "eEFEe" visit : Between Day 0 and Day 60

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

    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

    Measured: "eEFEe" visit : Between Day 0 and Day 60

  3. Performance on ecological assessments of executive functions in children (eEFEe test)

    administration time for each assessment on the eEFEe test.

    Test tasks :

    • Document sorting
    • Board game
    • Swimming bag and school bag
    • Vidéo game
    • Cooking
    • DIY

    Measured: 'eEFEe' visit: between Day 0 and Day 60

  4. Performance on ecological assessments of executive functions in children (eEFEe test)

    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

    Measured: 'eEFEe' visit: between Day 0 and Day 60

Secondary outcomes (4)
  1. Correlation with social cognition assessments

    Relationship between eEFEe task performance and standardized social cognition tests

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

  2. Correlation with standardized cognitive assessments

    Relationship between eEFEe task performance and standardized cognitive tests

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

  3. Influence of sociodemographic factors

    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).

    Measured: Baseline Visit : Day 0

  4. Age-related performance differences

    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.

    Measured: Baseline visit : Day 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2026
  2. Study start6 Feb 2024
  3. Primary completion2 Dec 2025
  4. Study completion12 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
144 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07654920
Sponsor's protocol ID
2023-A02174-41
Acronym
DFEE
Status last verified
Jun 2026
First submitted
18 Feb 2026
Last updated
17 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing eEFEe Ecological Assessment and Standardized Testing in people with Executive Functions (EF) and Cognitive Development, run by Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.

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