Prenatal Alcohol ExposureALTEMONCT03793920
Effects of Prenatal Alcohol Exposure on Emotional and Cognitive Abilities in Adults
A study testing Facial Emotion Test in people with Prenatal Alcohol Exposure, run by University Hospital, Lille at 2 sites in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Prenatal Alcohol Exposure
- What is being tested?
- Facial Emotion Test
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 2 sitesFrance
- Study dates
- 8 Nov 2018to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Behavioral Exploration of Cognitive and Emotional Alterations in Adult Individuals Exposed to Alcohol During the Prenatal Period
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.
Read the 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
- Conditions
- Prenatal Alcohol Exposure
- Being tested
- Facial Emotion Test
- Keywords
- Prenatal alcohol exposure, Emotional, Cognition, Addiction, Fetal Alcohol Syndrome
- Medical subject headings
- Behavior, Addictive, Fetal Alcohol Spectrum Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facial Emotion TestOther
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.
| Study group | Role | What they receive |
|---|---|---|
| PEA patients without alcohol disorder | Experimental | A group of 36 PEA patient without alcohol-dependence (AD), performing 6 behavioral tasks. Receives: Other: Facial Emotion Test |
| PEA patients with alcohol disorder | Sham comparator | A group of 36 PEA participants, currently alcohol-dependent, performing 6 behavioral tasks. Receives: Other: Facial Emotion Test |
| Healthy controls with AD father | Sham comparator | A group of 36 non-alcohol-dependent controls whose father was alcohol-dependent during their childhood and adolescence, performing 6 behavioral tasks. Receives: Other: Facial Emotion Test |
| Healthy controls without AD father | Sham comparator | A group of 36 non-alcohol-dependent controls whose father was not alcohol-dependent during their childhood and adolescence, performing 6 behavioral tasks. Receives: Other: Facial Emotion Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one day
Secondary outcomes (5)
Psychopathological assessment by Mini International Neuropsychiatric Interview MINI
Presence of psychiatric disorders by a standardized psychiatric interview
Measured: one day
Percentage of correct answers ant latency of behavioral answers
Performance of behavioral tasks
Measured: one day
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
Measured: one day
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.
Measured: one day
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)
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2019
- Study start8 Nov 2018
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Why it stopped: COVID
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prenatal Alcohol ExposureStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier COTTENCIN, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03793920
- Sponsor's protocol ID
- 2015_76
- Other IDs
- 2017-A00843-50
- Acronym
- ALTEMO
- Status last verified
- May 2026
- First submitted
- 18 Dec 2018
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Exploration of Cognitive and Emotional Alterations in Adult Individuals Exposed to Alcohol During the Prenatal Period
- ClinicalTrials.gov ID
- NCT03793920
- Acronym / sponsor ID
- ALTEMO / 2015_76
- Conditions
- Prenatal Alcohol Exposure
- Keywords
- Prenatal alcohol exposure, Emotional, Cognition, Addiction, Fetal Alcohol Syndrome
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 8 Nov 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 4 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PEA patients without alcohol disorder | Experimental | Other: Facial Emotion TestA group of 36 PEA patient without alcohol-dependence (AD), performing 6 behavioral tasks. |
| PEA patients with alcohol disorder | Sham comparator | Other: Facial Emotion TestA group of 36 PEA participants, currently alcohol-dependent, performing 6 behavioral tasks. |
| Healthy controls with AD father | Sham comparator | Other: Facial Emotion TestA group of 36 non-alcohol-dependent controls whose father was alcohol-dependent during their childhood and adolescence, performing 6 behavioral tasks. |
| Healthy controls without AD father | Sham comparator | Other: Facial Emotion TestA group of 36 non-alcohol-dependent controls whose father was not alcohol-dependent during their childhood and adolescence, performing 6 behavioral tasks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Facial Emotion TestAll 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. | Other | Healthy controls with AD father, Healthy controls without AD father, PEA patients with alcohol disorder, PEA patients without alcohol disorder |
Primary outcome
Percentage of correct answers of an emotional facial expression (EFE)
Time frame: one day
Performance of an emotional facial expression (EFE) decoding task in EPA subjects and compare it to non-alcohol dependent controls
5 secondary outcomes
Psychopathological assessment by Mini International Neuropsychiatric Interview MINI
Time frame: one day
Percentage of correct answers ant latency of behavioral answers
Time frame: one day
State-Trait-Anxiety Inventory (STAI) score
Time frame: one day
Beck Depression Inventory score
Time frame: one day
Toronto Alexithymia Scale TAS-20 score
Time frame: one day
Results and safety
The study was stopped early (reason given: COVID). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier COTTENCIN, MD, PhD principal investigator
University Hospital, Lille
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Facial Emotion Test in people with Prenatal Alcohol Exposure, run by University Hospital, Lille at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: COVID). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of correct answers of an emotional facial expression (EFE) (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.