TerminatedNot Applicable

Effects of Prenatal Alcohol Exposure on Emotional and Cognitive Abilities in Adults

Stopped: COVID

France14 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 range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of correct answers of an emotional facial expression (EFE)

Timeframe: one day

Trial details

NCT IDNCT03793920

SponsorUniversity Hospital, Lille

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12-31

View on ClinicalTrials.gov More Prenatal Alcohol Exposure trials