Clinical trial NCT05383235: Facial Emotion Recognition in Patients Who Committed Sexual Assault Against Children: an EEG Study
Official title: Facial Emotion Recognition in Patients Who Committed Sexual Assault Against Children: an EEG Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Child Sexual Abuse
Emotion Recognition
Keywords: facial emotion recognition
sexual offenders against children
LPP
Lead sponsor: Hôpital le Vinatier
Sponsor class: OTHER
First posted: 2022-05-20
Enrollment: 56
Sex: MALE
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: PATIENTS:

1. ROUTINE CARE : retrieval of sociodemographic characteristics, medical and psychological assessment, multidisciplinary meeting
2. RUN-IN PERIOD:

   * Eligibility criteria will be assessed during the multidisciplinary meeting
   * Delivery of the information note
3. STUDY:

   * Collection of consent form
   * Facial emotion stimuli presentation task with EEG recording and facial emotion recognition task
   * Neuropsychological evaluation
   * Scales + questionnaires
   * Debriefing

CONTROLS:

1. RUN-IN PERIOD phone call:

   * Study presentation
   * Retrieval of sociodemographic characteristics including age and educational level for matching with patients
   * Assessment of eligibility criteria
   * Psychiatric assessment with MINI 5.0 evaluation
2. STUDY:

   * Delivery of the information note
   * Collection of consent form
   * Facial emotion stimuli presentation task with EEG recording and facial emotion recognition task
   * Neuropsychological evaluation
   * Scales + questionnaires
   * Debriefing
Primary purpose: PREVENTION

Brief summary: This study aims to compare the emotional processing in sexual offenders against children versus healthy volunteers using an objective electrophysiological measurement (EEG) during a facial emotion stimuli presentation task. Secondary goal is to assess emotion recognition performances in this population and evaluate the impact of various factors on these performances (type of emotion, age and sex of person expressing the emotion, neuropsychological and cognitive abilities of the subjects).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Amplitude of LPP during the facial emotion stimuli presentation task
timeFrame: one day
Secondary outcomes:
measure: Facial emotion recognition abilities
timeFrame: one day
measure: TOM-15 (Theory Of Mind 15)
timeFrame: one day
measure: TAS20 (Toronto Alexithymia Scale 20)
timeFrame: one day
measure: PCL-R SV (Psychopathy Checklist Revised - Short Version)
timeFrame: one day
measure: QCAE (Questionnaire of Cognitive and Affective Empathy)
timeFrame: one day
measure: CECA-Q (Childhood Experiences of Care and Abuse - Questionnaire)
timeFrame: one day
Other outcomes:
Locations:
city: Bron
country: France
facility: Centre Hospitalier Le Vinatier
state: Rhône Alpes
Study officials:
affiliation: CH le Vinatier
name: Sabine MOUCHET, PH
role: PRINCIPAL_INVESTIGATOR
References: