- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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) (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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Rennes, France, 35043
- LP3C - Université Rennes II
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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:
|
"eEFEe" visit : Between Day 0 and Day 60
|
|
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 :
|
"eEFEe" visit : Between Day 0 and Day 60
|
|
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 :
|
'eEFEe' visit: between Day 0 and Day 60
|
|
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 :
|
'eEFEe' visit: between Day 0 and Day 60
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
At the end of the study, when all the data have been collected
|
|
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
|
At the end of the study, when all the data have been collected
|
|
Influence of sociodemographic factors
Time Frame: Baseline Visit : Day 0
|
Collection of sociodemographic data :
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
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.
|
Baseline visit : Day 0
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2023-A02174-41
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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