Study Stopped
Investigator Departure
Impact of Another Person's Presence on Brain and Behavioral Performance
SOFEE
Impact of the Presence of a Familiar Peer of the Same Age on the Behavioral Performance of the Child, Adolescent, and Young Adult and Study of the Biological Correlates by Neuroimagery
1 other identifier
interventional
112
1 country
1
Brief Summary
In a recent study, investigators provided the first neuroscientific data on social facilitation. This neuroimaging study, performed in the macaque monkey, shows a marked improvement in performance in a simple task when a congener is present compared to when the animal performs the task alone. This social facilitation is accompanied by a significant increase in brain activity within the fronto-parietal network of attention. No variation in activity, however, is observed in the cerebral network of motivation. These results argue in favor of the implication of attentional processes in the phenomenon of social facilitation. The challenge now is to determine whether social facilitation is always based on the attention network (whatever the task) or, alternatively, whether it increases activity in any cerebral circuit involved depending on the task performed and the population studied. This hypothesis, which the investigators have named the "multi-mediator model of social facilitation", has the advantage of reconciling the attentional and motivational theories of social facilitation, which are not mutually exclusive. This hypothesis also provides an explanation for the pervasiveness (across species and different ages for humans) of social facilitation. The main objective of SOFEE is to gather neuroscientific evidence to support the multi-facilitator model of social facilitation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2019
Longer than P75 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
February 14, 2018
CompletedFirst Posted
Study publicly available on registry
March 5, 2018
CompletedStudy Start
First participant enrolled
July 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 5, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 5, 2022
CompletedAugust 5, 2025
July 1, 2025
3.3 years
February 14, 2018
July 30, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Behavioral performance evaluation
percentage of correct answers and reaction time when performing cognitive number and rhyme comparison tasks in the presence or absence of a familiar peer
an average of 5 years
identification through Functional Magnetic Resonance Imaging (fMRI ) of brain activity related to the presence of others
Comparison of activity in the three populations tested (children, adolescents, adults)
an average of 5 years
Secondary Outcomes (1)
Determination of individual characteristics
an average of 5 years
Study Arms (1)
Behavioral test and fMRI
EXPERIMENTALNeuropsychological tests and training in behavioral tasks and a Functional Magnetic Resonance Imaging (fMRI) exam
Interventions
Part 1: to determine the cognitive capacity, the subjects undergo different neuropsychological tests To determine individual characteristics children, adolescents and adults complete self-assessment questionnaires . Adults spend a semi-directive interview. Part 2: while the subject 1 (S1) is installed in the MRI, he perform behavioral tasks with the subject 2 (S2) (familiar peer of the same age ± 2 years) installed in an adjacent room, alternating periods when S1 is observed by S2 (condition "Social") and periods when S1 is not observed by S2 (condition "Alone").
Eligibility Criteria
You may qualify if:
- Girl or boy aged ≥ 8 years and ≤ 12 years old for children,
- Girl or boy aged ≥ 13 years and ≤ 19 years old for teenagers,
- Woman or man age ≥ 20 years and ≤ 35 years old for young adults,
- French mother tongue,
- With the right to a social security scheme or similar,
- With informed consent form signed by the legal representatives and the subject, for minors,
- Has signed the informed consent form, for adults.
You may not qualify if:
- Known acquired neurological disorders, including epilepsy,
- Known psychiatric disorders,
- Complications at birth requiring admission to neonatal intensive care unit,
- Ongoing treatment with drugs affecting the central nervous system,
- Significant hearing impairment,
- Uncorrected visual inadequacy,
- Left manual preference,
- Contraindications to the MRI examination (people using a pacemaker or an insulin pump, people wearing a metal prosthesis or an intracerebral clip as well as claustrophobic subjects),
- Refusal of the subject or parents of the subject to be informed of any anomalies detected on the MRI,
- Protected persons other than children
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CH Le Vinatier
Bron, Auvergne-Rhône-Alpes, 69678, France
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
POISSON ALICE, MD
CH LE VINATIER
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 14, 2018
First Posted
March 5, 2018
Study Start
July 1, 2019
Primary Completion
October 5, 2022
Study Completion
October 5, 2022
Last Updated
August 5, 2025
Record last verified: 2025-07