Clinical trial NCT03793920: Effects of Prenatal Alcohol Exposure on Emotional and Cognitive Abilities in Adults
Official title: Behavioral Exploration of Cognitive and Emotional Alterations in Adult Individuals Exposed to Alcohol During the Prenatal Period
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prenatal Alcohol Exposure
Keywords: Prenatal alcohol exposure
Emotional
Cognition
Addiction
Fetal Alcohol Syndrome
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2019-01-04
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Hypothesis:

Individuals presenting with prenatal alcohol exposure (PEA) show emotional abilities deficits, and imbalance between the two systems involved in decision-making according to dual-process models, namely an under-activated reflective system (involved in deliberate behaviors) and an over-activated affective-automatic one (involved in impulsive behaviors).

Primary objective:

To explore performance (as a percentage of correct answers) in an emotional facial expression decoding task in PEA participants compared to controls without alcohol disorder.

Detailed description: Each participant will undergo 2 visits :

First visit :

* Checking inclusion and non-inclusion criteria
* Note of information and consent form
* Record of concomitant treatments and anamnestic elements
* Alcohol, Tobacco, and Toxic Consumption
* Urinary Toxicity Test for Control Groups
* Laterality test (Hecaen, 1984)
* Brief visual and auditory acuity test
* Standardized psychiatric interview (Mini International Neuropsychiatric Interview - MINI)

Second visit = Experimental testing

* State-Trait Anxiety Inventory, Beck Depression Inventory, Inventory of Interpersonal Problems, Toronto Alexithymia Scale (TAS-20).
* Participant installation and testing: 6 behavioral tasks on a computer (also used to collect responses, except for task 2, see details below) :

Task 1 (MAIN): Test for recognition of facial emotions Task 2: 'Reading the Mind in the Eyes Test' (Decoding of complex emotional states) Task 3: Emotional evaluation of natural scenes Task 4: Target detection (measure of attentional bias towards alcohol-related stimuli) Task 5: Go / No-Go evaluating the interactions between inhibition processes and auto-affective system Task 6: "N-back" evaluating the interactions between working memory and automatic-affective system

Eligibility criteria: Inclusion Criteria:

* Man or woman aged between 18 and 60 years
* Able to understand and to speak French
* Able to understand Note of information and to sign consent form
* Available health insurance
* Normal (or corrected to normal) vision and audition
* For women: Negative pregnancy test or menopausal for at least one year
* For Group 1 only : PEA criteria and no alcohol consumption within the three days preceding the experiment.
* For Group 2 only : PEA criteria, diagnosed with severe alcohol addiction and currently abstinent (for at least 15 days).
* For Group 3 only : Non-alcohol-dependent controls. No alcohol consumption within the three days preceding the experiment and father diagnosed with severe alcohol addiction.
* For Group 4 only : Non-alcohol-dependent controls. No alcohol consumption within the three days preceding the experiment.

Exclusion Criteria:

* Refusal of participation after clear and fair information on the study.
* Visual or auditory sensory disability to participate in the study.
* Benzodiazepines and / or Antipsychotic concomitant treatment.
* History of (or current) neurologic disease
* History of (or current) psychiatric disorder (apart alcohol-dependence for the PEA-alcohol-dependent group)
* Psychoactive Substance Use or Abuse other than tobacco and alcohol.
* Pregnant or breast-feeding women.
* Underage (\<18 yo) or adults under guardianship, judicial protection, or deprived of liberty.

Primary outcomes:
measure: Percentage of correct answers of an emotional facial expression (EFE)
timeFrame: one day
Secondary outcomes:
measure: Psychopathological assessment by Mini International Neuropsychiatric Interview MINI
timeFrame: one day
measure: Percentage of correct answers ant latency of behavioral answers
timeFrame: one day
measure: State-Trait-Anxiety Inventory (STAI) score
timeFrame: one day
measure: Beck Depression Inventory score
timeFrame: one day
measure: Toronto Alexithymia Scale TAS-20 score
timeFrame: one day
Other outcomes:
Locations:
city: Lille
country: France
facility: CSAPA
city: Lille
country: France
facility: CHRU Lille, Fontan2
Study officials:
affiliation: University Hospital, Lille
name: Olivier COTTENCIN, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: