- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05383235
Facial Emotion Recognition in Patients Who Committed Sexual Assault Against Children: an EEG Study (EMOREC)
Study Overview
Status
Conditions
Detailed Description
Sexual abuse is a major public health issue. Apart from medical care of victims, it appears essential to intervene with sexual offenders for prevention purposes (from primary prevention to avoid a first sexual abuse to secondary and tertiary prevention to avoid recurrence). In order to improve those prevention strategies, further understanding of offenders neuropsychological and cognitive processes is needed.
Facial emotion recognition capacities, that play a major role in social cognition and generation of appropriate social behavior, has been the subject of few studies in sexual offenders. These studies show heterogeneous results and only one of them specifically targets sexual offenders against children. Furthermore, no study has investigated facial emotion recognition in this population with an objective measurement of emotional processing, such as electroencephalographic (EEG) activity. LPP (late positive potential) amplitude, measured in EEG, is a marker of emotional processing and appears to be modified in particular populations (eg. psychopaths) in response to negative visual stimuli compared to positive stimuli.
The investigators aim to determine whether LPP amplitude in response to negative facial expressions is modified in sexual offenders against children compared to healthy volunteers and compared to amplitude in response to positive facial expressions.
Effect of facial emotion characteristics (type of emotion, age and sex of person expressing the emotion) on EEG response will be assessed.
Various neuropsychological and cognitive characteristics (facial emotion recognition, theory of mind, psychopathic traits, childhood trauma, and alexithymia) of patients and controls will also be measured through neuropsychological evaluation and completion of scales and questionnaires, in order to investigate the impact of those factors on facial emotion recognition performances.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Rhône Alpes
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Bron, Rhône Alpes, France, 69678
- Centre Hospitalier Le Vinatier
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria SUBJECTS - Sexual offenders against children:
- Right-handed ;
- Patient refered to the referral platform for treatment of sexual offenders in Le Vinatier Hospital Center for evaluation of child abuse ;
- Without any Axis 1 disorder ;
- Having given informed consent ;
- Affiliated to French social health care
Exclusion Criteria:
- Intellectual disability (identified during routine care in the referral platform for treatment of sexual offenders);
- Poor understanding of tests and scales instructions ;
- Neurological or neurodevelopmental history resulting in cognitive impairment with loss of autonomy ;
- Gardianship or other tutelage measure
Healthy controls :
Inclusion Criteria:
- Right-handed ;
- Without criminal background ;
- Without any DSM-5 psychiatric disorder (past or present, personal or familial in a first-degree relative) ;
- Non-caregiver employee of Le Vinatier Hospital Center.
Exclusion Criteria:
- Intellectual disability (using fNART if clinical suspicion during run-in period);
- Poor understanding of tests and scales instructions ;
- Neurological or neurodevelopmental history resulting in cognitive impairment with loss of autonomy ;
- Gardianship or other tutelage measure.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Healthy controls
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2. RUN-IN PERIOD :
Other Names:
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Experimental: Sexual offenders against children
sexual offenders against children
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1. ROUTINE CARE : retrieval of sociodemographic characteristics, medical and psychological assessment, multidisciplinary meeting about the patient
2. RUN-IN PERIOD :
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Amplitude of LPP during the facial emotion stimuli presentation task
Time Frame: one day
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The facial emotion stimuli presentation task is based on pictures from the Radbout Faces Database (RaFD). It includes pictures of male and female subjects, adults and children expressing positive, neutral or negative emotion. During the task, cerebral activity will be recorded by EEG to measure amplitude and latency of the LPP (Late Positive Potential). |
one day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Facial emotion recognition abilities
Time Frame: one day
|
Subjects and controls will be presented with facial emotion stimuli from the Radbout Faces Database (RaFD). It includes pictures of male and female subjects, adults and children expressing positive, neutral or negative emotion. We will measure recognition abilities (% correct response rate, response time, intensity and valence ratings). |
one day
|
|
TOM-15 (Theory Of Mind 15)
Time Frame: one day
|
validated test for assessment of theory of mind
|
one day
|
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TAS20 (Toronto Alexithymia Scale 20)
Time Frame: one day
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validated scale for assessment of alexithymia Scores vary from 20/100 (low level of alexithymia) to 100/100 (high level of alexithymia)
|
one day
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PCL-R SV (Psychopathy Checklist Revised - Short Version)
Time Frame: one day
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validated checklist for assessment of psychopathy Scores vary from 0/24 (no psychopathic traits) to 24/24 (high level of psychopathic traits)
|
one day
|
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QCAE (Questionnaire of Cognitive and Affective Empathy)
Time Frame: one day
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validated questionnaire for assessment of cognitive and affective empathy Affective empathy scores vary from 12/48 (low level of affective empathy) to 48/48 (high level of affective empathy). Cognitive empathy scores vary from 19/76 (low level of cognitive empathy) to 76/76 (high level of cognitive empathy). Total empathy scores vary from 31/124 (low level of empathy) to 124/124 (high level of empathy). |
one day
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CECA-Q (Childhood Experiences of Care and Abuse - Questionnaire)
Time Frame: one day
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validated questionnaire for assessment of childhood experience of care and abuse Global parental antipathy scores vary from 20/160 (low level of parental antipathy) to 160/160 (high level of parental antipathy). Neglect scores vary from 20/160 (low level of neglect) to 160/160 (high level of neglect). Physical abuses scores vary from 0/8 (no physical abuses) to 8/8 (high level of physical abuses during childhood) Scores of sexual abuse vary from 0 (no sexual abuse) à 7 (serious sexual abuse) Prevalence of psychological abuse vary from 0/34 (no psychological abuse) to 34/34 (multiple psychological abuses) Frequence of psychological abuse vary from 0/102 ( no psychological abuse) to 102/102 (frequent psychological abuse) |
one day
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sabine MOUCHET, PH, CH le vinatier
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
- 2021-A02763-38
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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