An interventional study of Food Assistance and Psychological Follow-Up in Trauma and Stress-related Disorders, Food Insecurity and Child Maltreatment, sponsored by University of Lorraine. Not yet recruiting at 6 sites in France. Open to participants aged 18 Years to 25 Years. Per ClinicalTrials.gov, last updated 2026-05-05.
Sponsored by University of Lorraine · Not applicable, Interventional, and Supportive care
The MISAPSY study (Childhood Maltreatment, Food Insecurity, Psychological Distress and Professional Integration Among Socioeconomically Disadvantaged Young Adults) aims to model the complex interrelations between child maltreatment, trauma exposure, food insecurity, and psychological distress among precarious young adults enrolled in French youth employment and social integration services (Mission Locale).
Adopting a methodology structured around three complementary components, this study consists of: (1) a cross-sectional survey to identify key associations ; (2) a qualitative study based on semi-structured interviews exploring psychologists' subjective experiences, and (3) a longitudinal comparative interventional study involving two different support programs to assess and compare the impact of these interventions on participants' food insecurity and psychological well-being.
Using a multi-phase design, MISAPSY seeks to move beyond linear risk-factor models by adopting a systemic and network-based approach to mental health and social vulnerability. The study integrates quantitative analyses, including network analyses, qualitative exploration of professional practices, and comparative longitudinal intervention to inform more holistic, equitable, and transferable models of care for vulnerable young adults.
The MISAPSY study (Childhood Maltreatment, Food Insecurity, Psychological Distress and Professional Integration Among Socioeconomically disadvantaged Young Adults) is a mixed-methods research project designed to deepen the understanding of the interactions between child maltreatment, trauma exposure, food insecurity and psychological distress among precarious young adults enrolled in French youth employment and social integration services (Mission Locale). This population faces cumulative psychosocial vulnerabilities and remains underrepresented in mental health research. The study addresses this gap by combining quantitative, qualitative, and interventional approaches within a unified and theoretically grounded framework. The study aims to (1) identify key associations and symptom dynamics, (2) explore professional practices and representations of care, and (3) evaluate the effectiveness of integrated support interventions targeting both material and psychological needs.
The study is structured around three complementary research components:
Cross-sectional study: Collection of socio-demographic data and standardized questionnaires to assess child maltreatment, food insecurity, mental health status, resilience, defense mechanisms, substance use, and perceived social support. The data will be analyzed using descriptive and multivariate statistical techniques (R software). Network analyses will be performed.
Qualitative study: Semi-structured interviews will be conducted with psychologists employed at the Mission Locale (Local Youth Employment Center) to support young people. An analysis based on Consensual Qualitative Research will explore individual narratives and better understand the challenges related to the support provided to young people at the Mission Locale. The analyses will be performed using NVivo software.
Longitudinal comparative interventional study: comparison of two care programs. The control group receives weekly food assistance for 12 months. The experimental group receives an intervention combining weekly food assistance for 12 months and twice-monthly psychological follow-up for 6 months. Psychological sessions are delivered by trained psychodynamic psychologists who are partners of the Mission Locale.
Assessments are conducted at 4 timepoints: T0: baseline, T1: 3 months after baseline, T2: 6 months after baseline (end of the psychological intervention phase), and T3: 12 months after baseline (primary endpoint). It will be conducted combining standardized questionnaires and semi-structured interviews to assess the effectiveness of those interventions on participants' psychological distress and food insecurity. The persistence of the therapy's effects (6 months after the end of follow-up) is being investigated.
Data will be analyzed using mixed models and appropriate adjustments for multiple comparisons to assess intervention effectiveness.
By integrating network analysis with a mixed-methods framework, MISAPSY moves beyond linear risk-factor models to capture the dynamic and systemic nature of psychological distress and food insecurity among precarious young adults.
Registry procedures and quality factors include a Quality Assurance Plan (QAP) ensuring data validation, site monitoring, and ethical compliance through adherence to the Committee for the Protection of Persons (CPP) Ile-de-France XI and both Ethics Committees of University of Lorraine and University of Paris Cité; Data Checks \& Source Data Verification through automated validation rules; a Data Dictionary defining all variables, including sources, coding systems (e.g., ICD-10), and reference ranges; and Standard Operating Procedures (SOPs) will guide participant recruitment, data collection, data management, adverse event reporting, and change management to ensure consistency and compliance.
The sample size assessment calls for at least 384 participants for the cross-sectional study to ensure statistical power, 15 participants for the qualitative interviews to achieve data saturation, and 35 participants per group for the longitudinal study (70 in total), with repeated measurements over 12 months to track changes.
The plan for managing missing data incorporates multiple imputation techniques, sensitivity analyses, and reviews of data inconsistencies. The statistical analysis plan includes descriptive analyses for the mean, median, and standard deviations, as well as inferential analyses using logistic regression to identify risk factors, mixed-effects models for intervention outcomes, network analyses to observe the dynamics between symptoms, and thematic coding for the qualitative data analyzed with NVivo software.
53 studies on the registry are indexed under Trauma and Stressor Related Disorders; 28 are open to participants now.
This study's planned enrollment of 70 is above the median of 63 across 48 interventional studies indexed under Trauma and Stressor Related Disorders.
Browse Trauma and Stressor Related Disorders studies →University of Lorraine is the lead sponsor of 12 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Participants in this arm receive weekly food assistance for a duration of 12 months. The food support is intended to address food insecurity. Food distribution takes place within the usual Mission Locale setting.
Other: Food Assistance
Participants in this arm receive weekly food assistance for 12 months combined with twice-monthly psychological follow-up provided over a 6-month period. The psychological support aims to address psychological distress and trauma-related difficulties in addition to food insecurity. Participants remain in this intervention arm throughout the study, with repeated assessments conducted over a 12-month follow-up period. Psychological support is provided by trained, psychodynamic psychologists who are partners of the Mission Locale. Appointments are held at the young adult's usual Mission Locale location.
Other: Food Assistance · Behavioral: Psychological Follow-Up
Weekly food assistance provided to participants for a duration of 12 months, aimed at reducing food insecurity.
Twice-monthly psychological follow-up sessions provided over a 6-month period, delivered by trained psychodynamic psychologists, aiming to support psychological well-being and address trauma-related psychological distress.
Change in Food Insecurity Severity
Food insecurity assessed using the Food Insecurity Experience Scale (FIES), an 8-item standardized questionnaire. The total raw score ranges from 0 to 8, with higher scores indicating greater food insecurity severity. Changes in food insecurity severity over time will be compared between the two intervention arms to evaluate the added impact of psychological support alongside food assistance. The primary outcome is the change in FIES total score from baseline to 12 months (4 assessments), comparing the two intervention arms.
Time frame: T0: Baseline; T1: 3 months after baseline; T2: 6 months after baseline (end of the psychological follow-up); and T3: 12 months after baseline (end of the study)
Change in Anxiety Symptoms
Anxiety symptoms assessed using the Generalized Anxiety Disorder 7-item scale (GAD-7). Total scores range from 0 to 21, with higher scores indicating greater anxiety severity. The outcome is the change in GAD-7 total score from baseline to 12 months (4 assessments), in both intervention arms.
Time frame: T0: Baseline; T1: 3 months after baseline; T2: 6 months after baseline (end of the psychological follow-up), and T3: 12 months (end of the study)
Change in Depressive Symptoms
Depressive symptoms assessed using the Patient Health Questionnaire 9-item scale (PHQ-9). Total scores range from 0 to 27, with higher scores indicating greater depressive symptom severity. The outcome is the change in PHQ-9 total score from baseline to 12 months (4 assessments), in both intervention arms.
Time frame: T0: Baseline; T1: 3 months after baseline; T2: 6 months after baseline (end of the psychological follow-up); and T3: 12 months after baseline (end of the study).
Change in Post-Traumatic Stress Disorder Symptoms
Post-Traumatic Stress Disorder (PTSD) and Complex Post-Traumatic Stress Disorder (CPTSD) symptoms assessed using the International Trauma Questionnaire (ITQ), an 18-item self-report questionnaire. 6 items relate to PTSD cluster, 6 items relate to CPTSD cluster and 6 items relate to the Disorders in Self Organization (DSO) cluster. Each symptom item is rated on a 5-point Likert scale ranging from 0 to 4. A symptom is considered present if the score is ≥ 2. The outcome measure is the change in PTSD and CPTSD symptoms status (presence vs absence) from baseline to 12 months (4 assessments), between intervention arms.
Time frame: T0: Baseline; T1: 3 months after baseline; T2: 6 months after baseline (end of the psychological follow-up); and T3: 12 months after baseline (end of the study).
Participants' subjective experience
Participants' subjective experiences of the support, including perceived usefulness, acceptability, and barriers to engagement, will be assessed using semi-structured interviews. This outcome is exploratory and qualitative in nature.
Time frame: 3 months after baseline; 6 months after baseline; 12 months after baseline (end of the study)
Plan to share: No — Individual Participant Data (IPD) containing directly identifiable information will not be shared outside the study team. All data will be pseudonymized prior to analysis, and only fully anonymized datasets will be made available. Access to these anonymized data may be granted to collaborating researchers for secondary analyses, subject to data protection regulations, ethical approvals, and data-sharing agreements ensuring confidentiality and appropriate use.
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Trauma and Stressor Related Disorders→
University of Lorraine