Protocol Study on Addiction, Trauma and Immigration Among Vulnerable Young Adults in Grand Est

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.

• Anxiety [Срок оценки: 6 months]
• Depression [Срок оценки: 6 months]
• Alcohol use [Срок оценки: 6 months]
• Tobacco use [Срок оценки: 6 months]
• Cannabis use [Срок оценки: 6 months]