NCT07654920

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 6, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2025

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2026

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 17, 2026

Completed
Last Updated

June 17, 2026

Status Verified

June 1, 2026

Enrollment Period

1.8 years

First QC Date

February 18, 2026

Last Update Submit

June 12, 2026

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

    "eEFEe" visit : Between Day 0 and Day 60

  • 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

    "eEFEe" visit : Between Day 0 and Day 60

  • 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

    'eEFEe' visit: between Day 0 and Day 60

  • 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

    'eEFEe' visit: between Day 0 and Day 60

Secondary Outcomes (4)

  • Correlation with social cognition assessments

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

  • Correlation with standardized cognitive assessments

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

  • Influence of sociodemographic factors

    Baseline Visit : Day 0

  • Age-related performance differences

    Baseline visit : Day 0

Study Arms (1)

eEFEe Assessment - Children/Adolescents and Parents

EXPERIMENTAL

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.

Behavioral: eEFEe Ecological Assessment and Standardized Testing

Interventions

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.

eEFEe Assessment - Children/Adolescents and Parents

Eligibility Criteria

Age7 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LP3C - Université Rennes II

Rennes, 35043, France

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2026

First Posted

June 17, 2026

Study Start

February 6, 2024

Primary Completion

December 2, 2025

Study Completion

December 12, 2025

Last Updated

June 17, 2026

Record last verified: 2026-06

Locations