<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03793920</url>
  </required_header>
  <id_info>
    <org_study_id>2015_76</org_study_id>
    <secondary_id>2017-A00843-50</secondary_id>
    <nct_id>NCT03793920</nct_id>
  </id_info>
  <brief_title>Effects of Prenatal Alcohol Exposure on Emotional and Cognitive Abilities in Adults</brief_title>
  <acronym>ALTEMO</acronym>
  <official_title>Behavioral Exploration of Cognitive and Emotional Alterations in Adult Individuals Exposed to Alcohol During the Prenatal Period</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Lille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Lille</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hypothesis:&#xD;
&#xD;
      Individuals presenting with prenatal alcohol exposure (PEA) show emotional abilities&#xD;
      deficits, and imbalance between the two systems involved in decision-making according to&#xD;
      dual-process models, namely an under-activated reflective system (involved in deliberate&#xD;
      behaviors) and an over-activated affective-automatic one (involved in impulsive behaviors).&#xD;
&#xD;
      Primary objective:&#xD;
&#xD;
      To explore performance (as a percentage of correct answers) in an emotional facial expression&#xD;
      decoding task in PEA participants compared to controls without alcohol disorder.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Each participant will undergo 2 visits :&#xD;
&#xD;
      First visit :&#xD;
&#xD;
        -  Checking inclusion and non-inclusion criteria&#xD;
&#xD;
        -  Note of information and consent form&#xD;
&#xD;
        -  Record of concomitant treatments and anamnestic elements&#xD;
&#xD;
        -  Alcohol, Tobacco, and Toxic Consumption&#xD;
&#xD;
        -  Urinary Toxicity Test for Control Groups&#xD;
&#xD;
        -  Laterality test (Hecaen, 1984)&#xD;
&#xD;
        -  Brief visual and auditory acuity test&#xD;
&#xD;
        -  Standardized psychiatric interview (Mini International Neuropsychiatric Interview -&#xD;
           MINI)&#xD;
&#xD;
      Second visit = Experimental testing&#xD;
&#xD;
        -  State-Trait Anxiety Inventory, Beck Depression Inventory, Inventory of Interpersonal&#xD;
           Problems, Toronto Alexithymia Scale (TAS-20).&#xD;
&#xD;
        -  Participant installation and testing: 6 behavioral tasks on a computer (also used to&#xD;
           collect responses, except for task 2, see details below) :&#xD;
&#xD;
      Task 1 (MAIN): Test for recognition of facial emotions Task 2: 'Reading the Mind in the Eyes&#xD;
      Test' (Decoding of complex emotional states) Task 3: Emotional evaluation of natural scenes&#xD;
      Task 4: Target detection (measure of attentional bias towards alcohol-related stimuli) Task&#xD;
      5: Go / No-Go evaluating the interactions between inhibition processes and auto-affective&#xD;
      system Task 6: &quot;N-back&quot; evaluating the interactions between working memory and&#xD;
      automatic-affective system&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 8, 2018</start_date>
  <completion_date type="Anticipated">November 11, 2022</completion_date>
  <primary_completion_date type="Anticipated">November 11, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of correct answers of an emotional facial expression (EFE)</measure>
    <time_frame>one day</time_frame>
    <description>Performance of an emotional facial expression (EFE) decoding task in EPA subjects and compare it to non-alcohol dependent controls</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Psychopathological assessment by Mini International Neuropsychiatric Interview MINI</measure>
    <time_frame>one day</time_frame>
    <description>Presence of psychiatric disorders by a standardized psychiatric interview</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of correct answers ant latency of behavioral answers</measure>
    <time_frame>one day</time_frame>
    <description>Performance of behavioral tasks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>State-Trait-Anxiety Inventory (STAI) score</measure>
    <time_frame>one day</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beck Depression Inventory score</measure>
    <time_frame>one day</time_frame>
    <description>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.&#xD;
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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Toronto Alexithymia Scale TAS-20 score</measure>
    <time_frame>one day</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">144</enrollment>
  <condition>Prenatal Alcohol Exposure</condition>
  <arm_group>
    <arm_group_label>PEA patients without alcohol disorder</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A group of 36 PEA patient without alcohol-dependence (AD), performing 6 behavioral tasks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PEA patients with alcohol disorder</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>A group of 36 PEA participants, currently alcohol-dependent, performing 6 behavioral tasks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy controls with AD father</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>A group of 36 non-alcohol-dependent controls whose father was alcohol-dependent during their childhood and adolescence, performing 6 behavioral tasks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy controls without AD father</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>A group of 36 non-alcohol-dependent controls whose father was not alcohol-dependent during their childhood and adolescence, performing 6 behavioral tasks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Facial Emotion Test</intervention_name>
    <description>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.</description>
    <arm_group_label>Healthy controls with AD father</arm_group_label>
    <arm_group_label>Healthy controls without AD father</arm_group_label>
    <arm_group_label>PEA patients with alcohol disorder</arm_group_label>
    <arm_group_label>PEA patients without alcohol disorder</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Man or woman aged between 18 and 60 years&#xD;
&#xD;
          -  Able to understand and to speak French&#xD;
&#xD;
          -  Able to understand Note of information and to sign consent form&#xD;
&#xD;
          -  Available health insurance&#xD;
&#xD;
          -  Normal (or corrected to normal) vision and audition&#xD;
&#xD;
          -  For women: Negative pregnancy test or menopausal for at least one year&#xD;
&#xD;
          -  For Group 1 only : PEA criteria and no alcohol consumption within the three days&#xD;
             preceding the experiment.&#xD;
&#xD;
          -  For Group 2 only : PEA criteria, diagnosed with severe alcohol addiction and currently&#xD;
             abstinent (for at least 15 days).&#xD;
&#xD;
          -  For Group 3 only : Non-alcohol-dependent controls. No alcohol consumption within the&#xD;
             three days preceding the experiment and father diagnosed with severe alcohol&#xD;
             addiction.&#xD;
&#xD;
          -  For Group 4 only : Non-alcohol-dependent controls. No alcohol consumption within the&#xD;
             three days preceding the experiment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal of participation after clear and fair information on the study.&#xD;
&#xD;
          -  Visual or auditory sensory disability to participate in the study.&#xD;
&#xD;
          -  Benzodiazepines and / or Antipsychotic concomitant treatment.&#xD;
&#xD;
          -  History of (or current) neurologic disease&#xD;
&#xD;
          -  History of (or current) psychiatric disorder (apart alcohol-dependence for the&#xD;
             PEA-alcohol-dependent group)&#xD;
&#xD;
          -  Psychoactive Substance Use or Abuse other than tobacco and alcohol.&#xD;
&#xD;
          -  Pregnant or breast-feeding women.&#xD;
&#xD;
          -  Underage (&lt;18 yo) or adults under guardianship, judicial protection, or deprived of&#xD;
             liberty.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Olivier COTTENCIN, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Lille</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CSAPA</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU Lille, Fontan2</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>December 18, 2018</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>September 30, 2022</last_update_submitted>
  <last_update_submitted_qc>September 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Prenatal alcohol exposure</keyword>
  <keyword>Emotional</keyword>
  <keyword>Cognition</keyword>
  <keyword>Addiction</keyword>
  <keyword>Fetal Alcohol Syndrome</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03793920
org study id: 2015_76
secondary id: 2017-A00843-50
nct id: NCT03793920
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Percentage of correct answers of an emotional facial expression (EFE)
time frame: one day
description: Performance of an emotional facial expression (EFE) decoding task in EPA subjects and compare it to non-alcohol dependent controls
measure: Psychopathological assessment by Mini International Neuropsychiatric Interview MINI
time frame: one day
description: Presence of psychiatric disorders by a standardized psychiatric interview
measure: Percentage of correct answers ant latency of behavioral answers
time frame: one day
description: Performance of behavioral tasks
measure: State-Trait-Anxiety Inventory (STAI) score
time frame: one day
description: 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
measure: Beck Depression Inventory score
time frame: one day
description: 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.
measure: Toronto Alexithymia Scale TAS-20 score
time frame: one day
description: 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)
arm group label: PEA patients without alcohol disorder
arm group type: Experimental
description: A group of 36 PEA patient without alcohol-dependence (AD), performing 6 behavioral tasks.
arm group label: PEA patients with alcohol disorder
arm group type: Sham Comparator
description: A group of 36 PEA participants, currently alcohol-dependent, performing 6 behavioral tasks.
arm group label: Healthy controls with AD father
arm group type: Sham Comparator
description: A group of 36 non-alcohol-dependent controls whose father was alcohol-dependent during their childhood and adolescence, performing 6 behavioral tasks.
arm group label: Healthy controls without AD father
arm group type: Sham Comparator
description: A group of 36 non-alcohol-dependent controls whose father was not alcohol-dependent during their childhood and adolescence, performing 6 behavioral tasks.
intervention type: Other
intervention name: Facial Emotion Test
description: 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.
arm group label: Healthy controls with AD father
arm group label: Healthy controls without AD father
arm group label: PEA patients with alcohol disorder
arm group label: PEA patients without alcohol disorder
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Olivier COTTENCIN, MD, PhD
role: Principal Investigator
affiliation: University Hospital, Lille
facility: 
facility: 
country: France
responsible party type: Sponsor