Behavioral Exploration of Cognitive and Emotional Alterations in Adult Individuals Exposed to Alcohol During the Prenatal Period
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 14
- 试验地点
- 3
- 主要终点
- Percentage of correct answers of an emotional facial expression (EFE)
研究概览
简要总结
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.
详细描述
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) :
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
PEA patients without alcohol disorder
A group of 36 PEA patient without alcohol-dependence (AD), performing 6 behavioral tasks.
干预措施: Facial Emotion Test (Other)
PEA patients with alcohol disorder
A group of 36 PEA participants, currently alcohol-dependent, performing 6 behavioral tasks.
干预措施: Facial Emotion Test (Other)
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.
干预措施: Facial Emotion Test (Other)
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.
干预措施: Facial Emotion Test (Other)
结局指标
主要结局
Percentage of correct answers of an emotional facial expression (EFE)
时间窗: one day
Performance of an emotional facial expression (EFE) decoding task in EPA subjects and compare it to non-alcohol dependent controls
次要结局
- Psychopathological assessment by Mini International Neuropsychiatric Interview MINI(one day)
- State-Trait-Anxiety Inventory (STAI) score(one day)
- Percentage of correct answers ant latency of behavioral answers(one day)
- Beck Depression Inventory score(one day)
- Toronto Alexithymia Scale TAS-20 score(one day)