Behavior and Behavior MechanismsSOFEENCT03453216
Impact of Another Person's Presence on Brain and Behavioral Performance
A study testing neuropsychological tests in people with Behavior and Behavior Mechanisms, run by Hôpital le Vinatier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Behavior and Behavior Mechanisms
- What is being tested?
- neuropsychological tests
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2019to 5 Oct 2022
- 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 8 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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,
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- 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,
- Pregnancy for women of childbearing age: the possibility of pregnancy will be ruled out on questioning for inclusion,
- Protected persons other than children
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed description
The main objective is to study the effect of the presence of others on cognitive performance and its evolution during development by behavioral and neural measures. The secondary objective is to identify factors (psychological characteristics such as personality traits) explaining individual, behavioral and neural differences, sensitivity to the presence of others.
- Conditions
- Behavior and Behavior Mechanisms
- Being tested
- neuropsychological tests
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neuropsychological testsBehavioural
Also called Functional Magnetic Resonance Imaging (fMRI) exam
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").
| Study group | Role | What they receive |
|---|---|---|
| Behavioral test and fMRI | Experimental | Neuropsychological tests and training in behavioral tasks and a Functional Magnetic Resonance Imaging (fMRI) exam Receives: Behavioral: neuropsychological tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: an average of 5 years
Secondary outcomes (1)
Determination of individual characteristics
answers of self-assessment questionnaires and semi-directive interview
Measured: an average of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2018
- Study start1 Jul 2019
- Primary completion5 Oct 2022
- Study completion5 Oct 2022
Why it stopped: Investigator Departure
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavior and Behavior MechanismsStudies of the same condition, open and under way.
- More trials run by Hôpital le VinatierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- POISSON ALICE, MD, Principal investigator, CH LE VINATIER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03453216
- Sponsor's protocol ID
- 2016-A01477-44
- Acronym
- SOFEE
- Status last verified
- Jul 2025
- First submitted
- 14 Feb 2018
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03453216
- Acronym / sponsor ID
- SOFEE / 2016-A01477-44
- Conditions
- Behavior and Behavior Mechanisms
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigator Departure
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 5 Oct 2022 (actual)
- Study completion
- 5 Oct 2022 (actual)
- First posted
- 5 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The main objective is to study the effect of the presence of others on cognitive performance and its evolution during development by behavioral and neural measures. The secondary objective is to identify factors (psychological characteristics such as personality traits) explaining individual, behavioral and neural differences, sensitivity to the presence of others.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Behavioral test and fMRI | Experimental | Behavioral: neuropsychological testsNeuropsychological tests and training in behavioral tasks and a Functional Magnetic Resonance Imaging (fMRI) exam |
Who may qualify
- Ages
- 8 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (11 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neuropsychological testsAlso: Functional Magnetic Resonance Imaging (fMRI) examPart 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"). | Behavioural | Behavioral test and fMRI |
Primary outcome
Behavioral performance evaluation
Time frame: an average of 5 years
percentage of correct answers and reaction time when performing cognitive number and rhyme comparison tasks in the presence or absence of a familiar peer
identification through Functional Magnetic Resonance Imaging (fMRI ) of brain activity related to the presence of others
Time frame: an average of 5 years
Comparison of activity in the three populations tested (children, adolescents, adults)
1 secondary outcome
Determination of individual characteristics
Time frame: an average of 5 years
Results and safety
The study was stopped early (reason given: Investigator Departure). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
POISSON ALICE, MD principal investigator
CH LE VINATIER
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing neuropsychological tests in people with Behavior and Behavior Mechanisms, run by Hôpital le Vinatier 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 7 inclusion and 11 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: stopped early, as of the sponsor's last update on 5 Aug 2025. 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 was stopped early (reason given: Investigator Departure). Results are not available in the source record.
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?
Behavioral performance evaluation (time frame: an average of 5 years). The study lists 2 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 5 Aug 2025.