Trauma and Stress-related DisordersATICCNCT06922721
Protocol Study on Addiction, Trauma and Immigration Among Vulnerable Young Adults in Grand Est
An observational study of Trauma and Stress-related Disorders and Substance Use Disorder (SUD), run by University of Lorraine at 7 sites in France.
Trial summary
The ATICC study (Addiction, Trauma, and Immigration, Prevention and Cross-Cultural Support for Care) investigates the complex relationships between trauma, substance use, migration experiences, and mental health perceptions among vulnerable young adults in Transitional Housing (Foyers de Jeunes Travailleurs) in… Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Trauma and Stress-related Disorders, Substance Use Disorder (SUD), Substance Use Risk
- What is being tested?
- Focus group
- How many people
- 182 participants
- Where
- 7 sitesFrance
- Study dates
- 6 Jan 2025to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study population consists of young adults aged 16 to 25 years residing in Transitional Housing for Young Adults (Foyers de Jeunes Travailleurs, FJT) affiliated with the Union Régionale pour l'Habitat des Jeunes (URHAJ). These individuals meet specific vulnerability criteria and come from diverse life trajectories, including those aging out of child welfare services (ASE), individuals under judicial protection (PJJ), persons with disabilities, refugees, and single-parent families. Due to their backgrounds, these young adults face significant adversity, which may have profound effects on their mental health and well-being. This population is particularly exposed to psychosocial stressors, making them a relevant demographic for studying the interplay between trauma, substance use, and mental health care access.
Who may be able to join
- Resident in a Housing center, speak and read french, adult participants who are not under guardianship or curatorship, any cultural background.
Who cannot join
- minors, don't speak and read french, adults under guardianship and curatorship.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
France7 sites, 7 recruiting
- Recruiting
Les Compagnons du Devoir et du Tour de France
Jarville-la-Malgrange, 54140
Foyer de jeunes travailleurs, +33 3 83 57 81 10, mdeliot@compagnons-du-devoir.com
Maha Najdini, Phd student
- Recruiting
Résidence Habitat Jeunes Campus
Maxéville, 54320
ADALI-Habitat, +33 3 83 91 10 10, jeandenis.soulis@adali-habitat.fr
Maha Najdini, Phd student
- Recruiting
Association Carrefour
Metz, 57000
Association Carrefour, +33 3 87 75 07 26, jerome.zilliox@carrefourmetz.fr
Maha Najdini, Phd student
- Recruiting
Foyer des jeunes ouvriers
Metz, 57000
Foyers de jeunes travailleurs, +33 3 87 75 16 41, accueil@fjo-metz.fr
accueil@fjo-metz.fr
- Recruiting
Résidence des Abeilles ADALI-HABITAT
Nancy, 54000
Foyer de jeunes travailleurs, +33 3 83 91 10 10, jeandenis.soulis@adali-habitat.fr
Maha Najdini, Phd student
- Recruiting
Résidence MARAE
Nancy, 54000
Association AURELIE FINANCE, +33 3 83 39 99 00, nathalie.brot@afinance-asso.fr
Maha Najdini, Phd student
- Recruiting
Habitat Jeunes 3 frontières
Thionville, 57100
Foyers de jeunes travailleurs, +33 3 82 53 30 38, m.thiriet@fjt3f.com
Maha Najdini, Phd student
About this study
Official title: ATICC: A Mixed-Methods Study on Addiction, Trauma, and Immigration Among Vulnerable Young Adults in the Grand Est Youth Network
The ATICC study (Addiction, Trauma, and Immigration, Prevention and Cross-Cultural Support for Care) investigates the complex relationships between trauma, substance use, migration experiences, and mental health perceptions among vulnerable young adults in Transitional Housing (Foyers de Jeunes Travailleurs) in France. Using a tripartite methodology, the study includes: (1) a cross-sectional survey to identify risk factors, (2) qualitative interviews to explore individual experiences, and (3) a longitudinal intervention using focus groups to assess psychological well-being and attitudes toward care. The findings will contribute to developing culturally adapted prevention and support programs.
Read the detailed description
The ATICC study (Addiction, Trauma, and Immigration, Prevention and Cross-Cultural Support for Care) is a mixed-methods research project aimed at understanding the interplay between trauma, substance use, migration experiences, and mental health perceptions among vulnerable young adults residing in Transitional Housing for Young Adults (Foyers de Jeunes Travailleurs, FJT) in France. The study will identify key risk factors, assess barriers to healthcare access, and evaluate the effectiveness of group interventions in improving psychological well-being and attitudes toward mental health services.
The study is structured into three complementary research components:
Cross-sectional study: Utilizes standardized questionnaires to assess substance use behaviors, trauma history, mental health status, and barriers to healthcare. The data will be collected at baseline and analyzed using descriptive and multivariate statistical techniques (R software).
Qualitative study: Conducts semi-structured interviews with a subset of participants who engage in substance use. Thematic analysis using NVivo software will be applied to explore individual narratives and subjective experiences related to substance use and mental health perceptions.
Longitudinal interventional study: Implements focus group interventions within transitional housing settings to evaluate their impact on psychological well-being and attitudes toward healthcare. Pre- and post-intervention assessments will be conducted using validated psychological measures.
Data will be analyzed using mixed models and appropriate statistical corrections to assess intervention effectiveness.
Registry procedures and quality factors include a Quality Assurance Plan ensuring data validation, site monitoring, and ethical compliance through adherence to the Committee for the Protection of Persons (CPP) Ile-de-France; Data Checks \& Source Data Verification through automated validation rules and cross-checking against medical records; a Data Dictionary defining all variables, including sources, coding systems (e.g., ICD-10, WHO Drug Dictionary, MedDRA), and reference ranges; and Standard Operating Procedures (SOPs) for participant recruitment, data collection, data management, adverse event reporting, and change management to ensure consistency and compliance. The Sample Size Assessment includes at least 300 participants for the cross-sectional study to ensure statistical power, 40 participants for qualitative interviews to achieve data saturation, and 6-8 participants per focus group session, with repeated measures over six months to track changes. The plan for Missing Data incorporates multiple imputation techniques, sensitivity analyses, and data inconsistency reviews. The statistical analysis plan includes descriptive analyses for mean, median, and standard deviations, and inferential analyses using logistic regression for risk factor identification, mixed-effects models for intervention outcomes, and thematic coding for qualitative data analyzed with NVivo software. Ethical considerations and registration details confirm that the study has received ethical approval from the CPP Ile-de-France (November 18, 2024) and is registered with the French National Agency for the Safety of Medicines and Health Products (ANSM) under ID-RCB: 2024-A01534-43, with participant confidentiality maintained through anonymized data storage and GDPR-compliant procedures. This detailed description provides the necessary technical information on the ATICC study, ensuring compliance with clinical trial registration requirements.
- Being tested
- Focus group
- Keywords
- addiction, trauma, Immigration, Mental health, young adults, Substance use
- Medical subject headings
- Trauma and Stressor Related Disorders, Substance-Related Disorders, Behavior, Addictive, Wounds and Injuries, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus groupOther
The "Well-Being Coffee Group" intervention is implemented in two formats: in person and others via videoconference, all facilitated by the same psychologist throughout the study. Across all formats, participation is voluntary and follows an information phase and the signing of an informed consent form. Participants will complete standardized evaluation questionnaires at multiple time points. The discussion groups are designed to create a supportive and open environment that encourages free expression. Their goal is to provide participants with a space to share their thoughts, emotions, and personal experiences, as well as to reflect on those emerging from group discussions. Topics explored include identity, substance use, migratory experiences, and mental health, fostering meaningful dialogue and mutual support.
| Study group | Role | What they receive |
|---|---|---|
| group participants | Participant aged >18, Resident in a Housing center , Fluent in French, adult participants who are not under guardianship (tutelle) or curatorship (curatelle). Receives: Other: Focus group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attitudes toward mental health care
Attitudes toward mental health care is measured through changes in perceptions of mental health services, stigma, and willingness to seek care before and after the intervention through a validated scale.
Measured: 6 months
Secondary outcomes (5)
Anxiety
Anxiety is a mental health condition characterized by excessive worry, fear, or nervousness that can interfere with daily functioning. Generalized Anxiety Disorder (GAD) is one of the most common forms assessed using the GAD-7, a self-report screening measure developed to address limitations in existing anxiety assessments. The GAD-7, consisting of seven questions, is widely used in adult primary care and psychiatric settings due to its efficiency, reliability, and sensitivity to treatment-related changes.
Measured: 6 months
Depression
Depression is a mood disorder characterized by persistent sadness, loss of interest or pleasure in activities, and other symptoms that interfere with daily life. It can vary in severity and last for weeks, months, or even years. Depression in this study will be assessed using the PHQ-9, a screening tool used to assess the presence and severity of depression. It is based on the nine diagnostic criteria for major depressive disorder from the DSM-IV. Each question in the PHQ-9 assesses a specific symptom of depression and is rated on a scale from 0 to 3, depending on how often the symptom has been experienced in the last two weeks.
Measured: 6 months
Alcohol use
Alcohol use will be assessed using the Alcohol Use Disorders Identification Test (AUDIT) to identify individuals with risky or harmful alcohol consumption and detect alcohol dependence.
The AUDIT questionnaire consists of 10 questions, divided into three categories, alcohol consumption, alcohol-Related problems and signs of alcohol dependence.
Measured: 6 months
Tobacco use
Nicotine dependence is going to be assessed the Fagerström test for nicotine dependence that measures the level of nicotine addiction in individuals who smoke cigarettes. Each question is designed to evaluate the degree of nicotine dependence based on smoking behaviors.
Measured: 6 months
Cannabis use
Cannabis Abuse Screening Test (CAST) will be used to assess cannabis consumption. It is a six-question tool used to assess problematic cannabis use, and evaluates behaviors linked to cannabis use disorder (CUD), such as frequent consumption, inability to control use, neglect of responsibilities, tolerance, withdrawal symptoms, and continued use despite negative consequences.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start6 Jan 2025
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Trauma and Stress-related DisordersStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Lorraine
- Sponsor type
- University, hospital or other
- Collaborators
- French Institute for Public Health Research (IReSP)
- Responsible party
- Sponsor
- Investigators
- Aziz Essadek, Phd in psychology, Study director, University of Lorraine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06922721
- Sponsor's protocol ID
- 2024-A01534-43
- Acronym
- ATICC
- Status last verified
- Apr 2025
- First submitted
- 3 Apr 2025
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not share individual participant data (IPD) in order to protect the privacy and confidentiality of our study participants. Our publications will present aggregate findings and summary statistics without revealing any identifiable details.
Publications
Najdini M, Frigaux A, Mathieu J, Shadili G, Guenoun T, Vlachopoulou X, Belot RA, Bazan A, Gressier F, Robin M, Essadek A. ATICC: a mixed-methods study on addiction, trauma, and immigration among vulnerable young adults in the grand est youth network. BMC Psychol. 2025 May 30;13(1):582. doi: 10.1186/s40359-025-02738-5.
PubMed 40448223
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ATICC: A Mixed-Methods Study on Addiction, Trauma, and Immigration Among Vulnerable Young Adults in the Grand Est Youth Network
- ClinicalTrials.gov ID
- NCT06922721
- Acronym / sponsor ID
- ATICC / 2024-A01534-43
- Keywords
- addiction, trauma, Immigration, Mental health, young adults, Substance use
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- University of LorraineUniversity, hospital or other
- Collaborators
- French Institute for Public Health Research (IReSP)
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 10 Apr 2025 (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.
The ATICC study (Addiction, Trauma, and Immigration, Prevention and Cross-Cultural Support for Care) investigates the complex relationships between trauma, substance use, migration experiences, and mental health perceptions among vulnerable young adults in Transitional Housing (Foyers de Jeunes Travailleurs) in France. Using a tripartite methodology, the study includes: (1) a cross-sectional survey to identify risk factors, (2) qualitative interviews to explore individual experiences, and (3) a longitudinal intervention using focus groups to assess psychological well-being and attitudes toward care. The findings will contribute to developing culturally adapted prevention and support programs.
Detailed description
The ATICC study (Addiction, Trauma, and Immigration, Prevention and Cross-Cultural Support for Care) is a mixed-methods research project aimed at understanding the interplay between trauma, substance use, migration experiences, and mental health perceptions among vulnerable young adults residing in Transitional Housing for Young Adults (Foyers de Jeunes Travailleurs, FJT) in France. The study will identify key risk factors, assess barriers to healthcare access, and evaluate the effectiveness of group interventions in improving psychological well-being and attitudes toward mental health services.
The study is structured into three complementary research components:
Cross-sectional study: Utilizes standardized questionnaires to assess substance use behaviors, trauma history, mental health status, and barriers to healthcare. The data will be collected at baseline and analyzed using descriptive and multivariate statistical techniques (R software).
Qualitative study: Conducts semi-structured interviews with a subset of participants who engage in substance use. Thematic analysis using NVivo software will be applied to explore individual narratives and subjective experiences related to substance use and mental health perceptions.
Longitudinal interventional study: Implements focus group interventions within transitional housing settings to evaluate their impact on psychological well-being and attitudes toward healthcare. Pre- and post-intervention assessments will be conducted using validated psychological measures.
Data will be analyzed using mixed models and appropriate statistical corrections to assess intervention effectiveness.
Registry procedures and quality factors include a Quality Assurance Plan ensuring data validation, site monitoring, and ethical compliance through adherence to the Committee for the Protection of Persons (CPP) Ile-de-France; Data Checks \& Source Data Verification through automated validation rules and cross-checking against medical records; a Data Dictionary defining all variables, including sources, coding systems (e.g., ICD-10, WHO Drug Dictionary, MedDRA), and reference ranges; and Standard Operating Procedures (SOPs) for participant recruitment, data collection, data management, adverse event reporting, and change management to ensure consistency and compliance. The Sample Size Assessment includes at least 300 participants for the cross-sectional study to ensure statistical power, 40 participants for qualitative interviews to achieve data saturation, and 6-8 participants per focus group session, with repeated measures over six months to track changes. The plan for Missing Data incorporates multiple imputation techniques, sensitivity analyses, and data inconsistency reviews. The statistical analysis plan includes descriptive analyses for mean, median, and standard deviations, and inferential analyses using logistic regression for risk factor identification, mixed-effects models for intervention outcomes, and thematic coding for qualitative data analyzed with NVivo software. Ethical considerations and registration details confirm that the study has received ethical approval from the CPP Ile-de-France (November 18, 2024) and is registered with the French National Agency for the Safety of Medicines and Health Products (ANSM) under ID-RCB: 2024-A01534-43, with participant confidentiality maintained through anonymized data storage and GDPR-compliant procedures. This detailed description provides the necessary technical information on the ATICC study, ensuring compliance with clinical trial registration requirements.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| group participants | – | Other: Focus groupParticipant aged >18, Resident in a Housing center , Fluent in French, adult participants who are not under guardianship (tutelle) or curatorship (curatelle). |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population consists of young adults aged 16 to 25 years residing in Transitional Housing for Young Adults (Foyers de Jeunes Travailleurs, FJT) affiliated with the Union Régionale pour l'Habitat des Jeunes (URHAJ). These individuals meet specific vulnerability criteria and come from diverse life trajectories, including those aging out of child welfare services (ASE), individuals under judicial protection (PJJ), persons with disabilities, refugees, and single-parent families. Due to their backgrounds, these young adults face significant adversity, which may have profound effects on their mental health and well-being. This population is particularly exposed to psychosocial stressors, making them a relevant demographic for studying the interplay between trauma, substance use, and mental health care access.
Key inclusion criteria (1 listed)
- Resident in a Housing center, speak and read french, adult participants who are not under guardianship or curatorship, any cultural background.
Key exclusion criteria (1 listed)
- minors, don't speak and read french, adults under guardianship and curatorship.
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 |
|---|---|---|
| Focus groupThe "Well-Being Coffee Group" intervention is implemented in two formats: in person and others via videoconference, all facilitated by the same psychologist throughout the study. Across all formats, participation is voluntary and follows an information phase and the signing of an informed consent form. Participants will complete standardized evaluation questionnaires at multiple time points. The discussion groups are designed to create a supportive and open environment that encourages free expression. Their goal is to provide participants with a space to share their thoughts, emotions, and personal experiences, as well as to reflect on those emerging from group discussions. Topics explored include identity, substance use, migratory experiences, and mental health, fostering meaningful dialogue and mutual support. | Other | group participants |
Primary outcome
Attitudes toward mental health care
Time frame: 6 months
Attitudes toward mental health care is measured through changes in perceptions of mental health services, stigma, and willingness to seek care before and after the intervention through a validated scale.
5 secondary outcomes
Anxiety
Time frame: 6 months
Depression
Time frame: 6 months
Alcohol use
Time frame: 6 months
Tobacco use
Time frame: 6 months
Cannabis use
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Derived from this study: PubMed 40448223Najdini M, Frigaux A, Mathieu J, Shadili G, Guenoun T, Vlachopoulou X, Belot RA, Bazan A, Gressier F, Robin M, Essadek A. ATICC: a mixed-methods study on addiction, trauma, and immigration among vulnerable young adults in the grand est youth network. BMC Psychol. 2025 May 30;13(1):582. doi: 10.1186/s40359-025-02738-5.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. We will not share individual participant data (IPD) in order to protect the privacy and confidentiality of our study participants. Our publications will present aggregate findings and summary statistics without revealing any identifiable details.
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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.
Les Compagnons du Devoir et du Tour de France
Jarville-la-Malgrange, France
Aziz Essadek, Phd in psychology study director
University of Lorraine
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma and Stress-related Disorders and Substance Use Disorder (SUD), run by University of Lorraine at 7 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attitudes toward mental health care (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06922721, which also lists 1 linked publication.
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 10 Apr 2025.