Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-03-04 @ 7:50 PM
Study NCT ID:
NCT03793920
Status:
UNKNOWN
Last Update Posted:
2022-10-03
First Post:
2018-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Prenatal Alcohol Exposure on Emotional and Cognitive Abilities in Adults
Sponsor:
University Hospital, Lille
Organization:
Study Overview
Official Title:
Behavioral Exploration of Cognitive and Emotional Alterations in Adult Individuals Exposed to Alcohol During the Prenatal Period
Status:
UNKNOWN
Status Verified Date:
2022-09
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ALTEMO
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.
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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2017-A00843-50 | OTHER | ID-RCB number, ANSM | View |