Effects of Prenatal Alcohol Exposure on Emotional and Cognitive Abilities in Adults (ALTEMO)

May 20, 2026 updated by: University Hospital, Lille

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France, 59037
        • CSAPA
      • Lille, France
        • CHRU Lille, Fontan2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
one day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychopathological assessment by Mini International Neuropsychiatric Interview MINI
Time Frame: one day
Presence of psychiatric disorders by a standardized psychiatric interview
one day
Percentage of correct answers ant latency of behavioral answers
Time Frame: one day
Performance of behavioral tasks
one day
State-Trait-Anxiety Inventory (STAI) score
Time Frame: 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
one day
Beck Depression Inventory score
Time Frame: 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.
one day
Toronto Alexithymia Scale TAS-20 score
Time Frame: 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)
one day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

  • Principal Investigator: Olivier COTTENCIN, MD, PhD, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 8, 2018

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

December 18, 2018

First Submitted That Met QC Criteria

January 3, 2019

First Posted (Actual)

January 4, 2019

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015_76
  • 2017-A00843-50 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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