ALTEMO: Effects of Prenatal Alcohol Exposure on Emotional and Cognitive Abilities in Adults
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Each participant will undergo 2 visits :
First visit :
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Checking inclusion and non-inclusion criteria
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Note of information and consent form
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Record of concomitant treatments and anamnestic elements
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Alcohol, Tobacco, and Toxic Consumption
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Urinary Toxicity Test for Control Groups
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Laterality test (Hecaen, 1984)
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Brief visual and auditory acuity test
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Standardized psychiatric interview (Mini International Neuropsychiatric Interview - MINI)
Second visit = Experimental testing
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State-Trait Anxiety Inventory, Beck Depression Inventory, Inventory of Interpersonal Problems, Toronto Alexithymia Scale (TAS-20).
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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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: PEA patients without alcohol disorder A group of 36 PEA patient without alcohol-dependence (AD), performing 6 behavioral tasks. |
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.
|
| Sham Comparator: PEA patients with alcohol disorder A group of 36 PEA participants, currently alcohol-dependent, performing 6 behavioral tasks. |
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.
|
| Sham Comparator: 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. |
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.
|
| Sham Comparator: 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. |
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.
|
Outcome Measures
Primary Outcome Measures
- Percentage of correct answers of an emotional facial expression (EFE) [one day]
Performance of an emotional facial expression (EFE) decoding task in EPA subjects and compare it to non-alcohol dependent controls
Secondary Outcome Measures
- Psychopathological assessment by Mini International Neuropsychiatric Interview MINI [one day]
Presence of psychiatric disorders by a standardized psychiatric interview
- Percentage of correct answers ant latency of behavioral answers [one day]
Performance of behavioral tasks
- State-Trait-Anxiety Inventory (STAI) score [one day]
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
- Beck Depression Inventory score [one day]
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.
- Toronto Alexithymia Scale TAS-20 score [one day]
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)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Man or woman aged between 18 and 60 years
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Able to understand and to speak French
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Able to understand Note of information and to sign consent form
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Available health insurance
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Normal (or corrected to normal) vision and audition
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For women: Negative pregnancy test or menopausal for at least one year
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For Group 1 only : PEA criteria and no alcohol consumption within the three days preceding the experiment.
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For Group 2 only : PEA criteria, diagnosed with severe alcohol addiction and currently abstinent (for at least 15 days).
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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.
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For Group 4 only : Non-alcohol-dependent controls. No alcohol consumption within the three days preceding the experiment.
Exclusion Criteria:
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Refusal of participation after clear and fair information on the study.
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Visual or auditory sensory disability to participate in the study.
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Benzodiazepines and / or Antipsychotic concomitant treatment.
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History of (or current) neurologic disease
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History of (or current) psychiatric disorder (apart alcohol-dependence for the PEA-alcohol-dependent group)
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Psychoactive Substance Use or Abuse other than tobacco and alcohol.
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Pregnant or breast-feeding women.
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Underage (<18 yo) or adults under guardianship, judicial protection, or deprived of liberty.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CSAPA | Lille | France | 59037 | |
| 2 | CHRU Lille, Fontan2 | Lille | France |
Sponsors and Collaborators
- University Hospital, Lille
Investigators
- Principal Investigator: Olivier COTTENCIN, MD, PhD, University Hospital, Lille
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2015_76
- 2017-A00843-50