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临床试验/NCT07427524
NCT07427524尚未招募不适用

Psychosocial Intervention With Precarious Young People: a Comparative Longitudinal Study on Psychological Distress and Food Insecurity

University of Lorraine6 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2026年7月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
70
试验地点
6
主要终点
Change in Food Insecurity Severity

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

  • 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.

研究组 & 干预措施

Food Assistance Only (Control Group)

Active Comparator

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.

干预措施: Food Assistance (Other)

Food Assistance Plus Psychological Support (Experimental Group)

Experimental

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.

干预措施: Food Assistance (Other)

Food Assistance Plus Psychological Support (Experimental Group)

Experimental

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.

干预措施: Psychological Follow-Up (Behavioral)

结局指标

主要结局

Change in Food Insecurity Severity

时间窗: 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.

次要结局

  • Change in Anxiety Symptoms(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(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(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).)

研究者

发起方
University of Lorraine
申办方类型
Other
责任方
Sponsor

研究点 (6)

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