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

Prenatal Alcohol Exposure Clinical Trial

— ALTEMO  

Official title:

Behavioral Exploration of Cognitive and Emotional Alterations in Adult Individuals Exposed to Alcohol During the Prenatal Period

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03793920
• Other study ID #: 2015_76
• Secondary ID: 2017-A00843-50
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 8, 2018
• Est. completion date: November 11, 2022

Study information

• Verified date: September 2022
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 144
• Est. completion date: November 11, 2022
• Est. primary completion date: November 11, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prenatal Alcohol Exposure

Intervention

Other:
• 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.

Locations

Country	Name	City	State
France	CHRU Lille, Fontan2	Lille
France	CSAPA	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Psychopathological assessment by Mini International Neuropsychiatric Interview MINI	Presence of psychiatric disorders by a standardized psychiatric interview	one day
Secondary	Percentage of correct answers ant latency of behavioral answers	Performance of behavioral tasks	one day
Secondary	State-Trait-Anxiety Inventory (STAI) score	Score at STAI STAI is a psychological inventory based on a 4-point Likert scale and consists of 40 questions on a self-report basis	one day
Secondary	Beck Depression Inventory score	Score at Beck Depression Inventory The BDI consisted of twenty-one questions about how the subject has been feeling in the last week. Each question had a set of at least four possible responses, ranging in intensity. (0) I do not feel sad/ (1) I feel sad./ (2) I am sad all the time and I can't snap out of it/ (3) I am so sad or unhappy that I can't stand it.; When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is compared to a key to determine the depression's severity. The standard cut-off scores were as follows:0-9: indicates minimal depression/ 10-18: indicates mild depression/ 19-29: indicates moderate depression/ 30-63: indicates severe depression.	one day
Secondary	Toronto Alexithymia Scale TAS-20 score	Score at TAS-20 The Toronto Alexithymia Scale is a measure of deficiency in understanding, processing, or describing emotions. The current version has twenty statements rated on a five-point Likert scale. ( range : Strongly disagree/Disagree/ Neither agree nor disagree/ Agree/ Strongly agree)	one day