Effects of Prenatal Alcohol Exposure on Emotional and Cognitive Abilities in Adults (NCT03793920) | Clinical Trial Compass
UnknownNot Applicable
Effects of Prenatal Alcohol Exposure on Emotional and Cognitive Abilities in Adults
France144 participantsStarted 2018-11-08
Plain-language 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.
Who can participate
Age range18 Years – 60 Years
SexALL
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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.
What they're measuring
1
Percentage of correct answers of an emotional facial expression (EFE)