MISAPSY: Childhood Maltreatment, Food Insecurity, Psychological Distress and Professional Integration Among Socioeconomically Disadvantaged Young Adults
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Food Assistance, Psychological Follow-Up.
- Кому может быть актуально
- Состояния в реестре: Trauma and Stress-related Disorders, Food Insecurity, Child Maltreatment, Psychological Distress. Базовые параметры: 18 лет — 25 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Франция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Psychosocial Intervention With Precarious Young People: a Comparative Longitudinal Study on Psychological Distress and Food Insecurity
Обзор
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.
Подробное описание
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.
Вмешательства
- Другое Food Assistance
Weekly food assistance provided to participants for a duration of 12 months, aimed at reducing food insecurity. - Поведенческое Psychological Follow-Up
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.
Первичные конечные точки
- Change in Food Insecurity Severity [Срок оценки: 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)]
Вторичные конечные точки (3)
- Change in Anxiety Symptoms [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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).]
Критерии участия
Критерии включения
- 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).
Критерии исключения
- 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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Поддерживающая терапия
Центры проведения
Франция · 6 центров
- Mission Locale site Centre — Paris
- Mission Locale site Soleil — Paris
- Mission Locale site Avenir — Paris
- Mission Locale site Milord — Paris
- Mission Locale site Est — Paris
- Mission Locale site Pyrénées — Paris
Публикации
- 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. PMID 40893605
- 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. PMID 37513678
- 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. PMID 32174292
- 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.
- Cappelletti M, Mathieu J, Musso M, Shadili G, Bernateau I, Bazan A, Robin M, Essadek A. MISAPSY: childhood maltreatment, food insecurity, psychological distress and professional integration among socioeconomically disadvantaged young adults - a mixed-methods study protocol. BMC Psychol. 2026 Mar 13;14(1):576. doi: 10.1186/s40359-026-04292-0. PMID 41821102
Идентификаторы
NCT: NCT07427524 · 2025-A01928-41