- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07427524
MISAPSY: Childhood Maltreatment, Food Insecurity, Psychological Distress and Professional Integration Among Socioeconomically Disadvantaged Young Adults (PRESPA)
Psychosocial Intervention With Precarious Young People: a Comparative Longitudinal Study on Psychological Distress and Food Insecurity
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Aziz ESSADEK, PhD
- Phone Number: +33667344173
- Email: aziz.essadek@u-paris.fr
Study Contact Backup
- Name: Maud Cappelletti, PhD student
- Email: maud.cappelletti@univ-lorraine.fr
Study Locations
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Paris, France, 75011
- Mission Locale site Centre
-
Contact:
- Mission Locale
- Phone Number: +33144938123
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Principal Investigator:
- Maud Cappelletti, PhD student
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Paris, France, 75013
- Mission Locale site Soleil
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Principal Investigator:
- Maud Cappelletti, PhD student
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Contact:
- Mission Locale de Paris
- Phone Number: +33145852050
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Paris, France, 75014
- Mission Locale site Avenir
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Principal Investigator:
- Maud Cappelletti, PhD student
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Contact:
- Mission Locale de Paris
- Phone Number: +33140527730
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Paris, France, 75018
- Mission Locale site Milord
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Principal Investigator:
- Maud Cappelletti, PhD student
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Contact:
- Mission Locale de Paris
- Phone Number: +33144850118
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Paris, France, 75019
- Mission Locale site Est
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Principal Investigator:
- Maud Cappelletti, PhD student
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Contact:
- Phone Number: +33153728140
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Paris, France, 75020
- Mission Locale site Pyrénées
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Principal Investigator:
- Maud Cappelletti, PhD student
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Contact:
- Missions Locales de Paris
- Phone Number: +33144648610
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Be aged 18 to 25 years
- Be supported by a Mission Locale in Paris as part of a social and/or professional integration program
- Voluntarily participate in the study after receiving clear information and signing an informed consent form
- Experiencing severe food insecurity (positive response to item 8 of the FIES)
- Experiencing significant psychological distress, defined by: PHQ-9 score > 15; GAD-7 score > 10
- Have been exposed to at least one adverse childhood experience, identified via the CTQ-SF (Childhood Trauma Questionnaire - Short Form).
Exclusion Criteria:
- Being unable to provide informed consent due to impaired comprehension or communication skills
- Currently receiving psychiatric care for an acute or chronic mental illness requiring regular specialized treatment
- Experiencing a social or medical emergency incompatible with the study (e.g., unstable emergency housing, acute suicidal crisis, ongoing hospitalization)
- Being incarcerated, under guardianship or curatorship without specific legal authorization to participate in research
- Having previously participated in a similar study or currently being engaged in a structured psychological intervention protocol
- Having insufficient command of the French language, preventing comprehension of instructions, questionnaires, or interviews.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Food Assistance Only (Control Group)
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.
|
Weekly food assistance provided to participants for a duration of 12 months, aimed at reducing food insecurity.
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Experimental: Food Assistance Plus Psychological Support (Experimental Group)
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Food Insecurity Severity
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)
|
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.
|
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)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Anxiety Symptoms
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)
|
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.
|
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)
|
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Change in Depressive Symptoms
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).
|
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.
|
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).
|
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Change in Post-Traumatic Stress Disorder Symptoms
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).
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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.
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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).
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Participants' subjective experience
Time Frame: 3 months after baseline; 6 months after baseline; 12 months after baseline (end of the study)
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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.
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3 months after baseline; 6 months after baseline; 12 months after baseline (end of the study)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Aziz Essadek, PhD, Université de Paris Cité
Publications and helpful links
General Publications
- Guedeney A, Benamozig G, El Asmar K, Viaux Savelon S. Les jeunes des Missions locales de Paris et le risque suicidaire. Résultats préliminaires d'un essai contrôlé de proposition de suivi psychothérapeutique préventif du suicide (MLADO). Bulletin de l'Académie Nationale de Médecine. 1 juin 2023;207(6):779 86.
- Essadek A, Guenoun T, Gressier F, Najdini M, Cappelletti M, Frigaux A, Melchior M, Musso M, Robin M. Post-pandemic changes in anxiety and depression symptom networks among socioeconomically disadvantaged young Adults: A repeated cross-sectional study. SSM Popul Health. 2025 Aug 16;31:101854. doi: 10.1016/j.ssmph.2025.101854. eCollection 2025 Sep.
- Essadek A, Shadili G, Bergami Goulart Barbosa P, Assous A, Widart F, Payan S, Rabeyron T, Corruble E, Falissard B, Gressier F. Precarious Young Adults' Mental Health during the Pandemic: The Major Impact of Food Insecurity Independently of COVID-19 Diagnosis. Nutrients. 2023 Jul 24;15(14):3260. doi: 10.3390/nu15143260.
- Pourmotabbed A, Moradi S, Babaei A, Ghavami A, Mohammadi H, Jalili C, Symonds ME, Miraghajani M. Food insecurity and mental health: a systematic review and meta-analysis. Public Health Nutr. 2020 Jul;23(10):1778-1790. doi: 10.1017/S136898001900435X. Epub 2020 Mar 16.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Behavioral Symptoms
- Behavior
- Personal Satisfaction
- Trauma and Stressor Related Disorders
- Anxiety Disorders
- Depression
- Wounds and Injuries
- Psychological Well-Being
- Health Care Economics and Organizations
- Public Assistance
- Financing, Government
- Financing, Organized
- Economics
- Food Assistance
Other Study ID Numbers
- 2025-A01928-41
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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