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

NCT ID: NCT03793920

Last Updated: 2022-10-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-08
• Study Completion Date: 2022-11-11

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

Conditions

Prenatal Alcohol Exposure

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

PEA patients without alcohol disorder

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

Group Type: EXPERIMENTAL

Facial Emotion Test

Intervention Type: 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.

PEA patients with alcohol disorder

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

Group Type: SHAM_COMPARATOR

Facial Emotion Test

Intervention Type: 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

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

Group Type: SHAM_COMPARATOR

Facial Emotion Test

Intervention Type: 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 without AD father

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

Group Type: SHAM_COMPARATOR

Facial Emotion Test

Intervention Type: 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.

Interventions

Facial Emotion Test

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Olivier COTTENCIN, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

CSAPA

Lille, , France

CHRU Lille, Fontan2

Lille, , France

Countries

France

Other Identifiers

2017-A00843-50

Identifier Type: OTHER

Identifier Source: secondary_id

2015_76

Identifier Type: -

Identifier Source: org_study_id