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

NCT03793920 | Unknown

• 2 other identifiers: 2015_762017-A00843-50
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 2

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.

Conditions

Prenatal Alcohol Exposure

Keywords

Prenatal alcohol exposure; Emotional; Cognition; Addiction; Fetal Alcohol Syndrome

Outcome Measures

Primary Outcomes (1)

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

  Performance of an emotional facial expression (EFE) decoding task in EPA subjects and compare it to non-alcohol dependent controls

  one day

Secondary Outcomes (5)

• Psychopathological assessment by Mini International Neuropsychiatric Interview MINI

  one day

• Percentage of correct answers ant latency of behavioral answers

  one day

• State-Trait-Anxiety Inventory (STAI) score

  one day

• Beck Depression Inventory score

  one day

• Toronto Alexithymia Scale TAS-20 score

  one day

Study Arms (4)

PEA patients without alcohol disorder

EXPERIMENTAL

A group of 36 PEA patient without alcohol-dependence (AD), performing 6 behavioral tasks.

Other: Facial Emotion Test

PEA patients with alcohol disorder

SHAM COMPARATOR

A group of 36 PEA participants, currently alcohol-dependent, performing 6 behavioral tasks.

Other: Facial Emotion Test

Healthy controls with AD father

SHAM COMPARATOR

A group of 36 non-alcohol-dependent controls whose father was alcohol-dependent during their childhood and adolescence, performing 6 behavioral tasks.

Other: Facial Emotion Test

Healthy controls without AD father

SHAM COMPARATOR

A group of 36 non-alcohol-dependent controls whose father was not alcohol-dependent during their childhood and adolescence, performing 6 behavioral tasks.

Other: Facial Emotion Test

Interventions

Facial Emotion Test OTHER

All tasks will be delivered using a laptop and E-Prime 2 software (Psychology Software Tools, Inc., Pittsburgh), which will also be used to collect behavioral responses.

Healthy controls with AD father; Healthy controls without AD father; PEA patients with alcohol disorder; PEA patients without alcohol disorder

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (2)

CSAPA

Lille, 59037, France

Location

CHRU Lille, Fontan2

Lille, France

Location

MeSH Terms

Conditions

Behavior, Addictive; Fetal Alcohol Spectrum Disorders

Condition Hierarchy (Ancestors)

Compulsive Behavior; Impulsive Behavior; Behavior; Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Study Officials

• Olivier COTTENCIN, MD, PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2018
• First Posted: January 4, 2019
• Study Start: November 8, 2018
• Primary Completion: November 11, 2022
• Study Completion: November 11, 2022
• Last Updated: October 3, 2022

Record last verified: 2022-09

Locations

FR (2)