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.