Clinical trial NCT06922721: Protocol Study on Addiction, Trauma and Immigration Among Vulnerable Young Adults in Grand Est
Official title: ATICC: A Mixed-Methods Study on Addiction, Trauma, and Immigration Among Vulnerable Young Adults in the Grand Est Youth Network
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Trauma and Stress-related Disorders
Substance Use Disorder (SUD)
Substance Use Risk
Keywords: addiction
trauma
Immigration
Mental health
young adults
Substance use
Lead sponsor: University of Lorraine
Sponsor class: OTHER
Collaborators: name: French Institute for Public Health Research (IReSP)
First posted: 2025-04-10
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* Resident in a Housing center, speak and read french, adult participants who are not under guardianship or curatorship, any cultural background.

Exclusion Criteria:

* minors, don't speak and read french, adults under guardianship and curatorship.

Primary outcomes:
measure: Attitudes toward mental health care
timeFrame: 6 months
Secondary outcomes:
measure: Anxiety
timeFrame: 6 months
measure: Depression
timeFrame: 6 months
measure: Alcohol use
timeFrame: 6 months
measure: Tobacco use
timeFrame: 6 months
measure: Cannabis use
timeFrame: 6 months
Other outcomes:
Locations:
city: Jarville la Malgrange
country: France
facility: Les Compagnons du Devoir et du Tour de France
city: Maxéville
country: France
facility: Résidence Habitat Jeunes Campus
city: Metz
country: France
facility: Association Carrefour
city: Metz
country: France
facility: Foyer des jeunes ouvriers
city: Nancy
country: France
facility: Résidence des Abeilles ADALI-HABITAT
city: Nancy
country: France
facility: Résidence MARAE
city: Thionville
country: France
facility: Habitat Jeunes 3 frontières
Study officials:
affiliation: University of Lorraine
name: Aziz Essadek, Phd in psychology
role: STUDY_DIRECTOR
References: