NCT07427524

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
10mo left

Started Jul 2026

Geographic Reach
1 country

6 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress11%
Jul 2026Jun 2027

First Submitted

Initial submission to the registry

February 10, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 23, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

May 5, 2026

Status Verified

February 1, 2026

Enrollment Period

11 months

First QC Date

February 10, 2026

Last Update Submit

April 28, 2026

Conditions

Keywords

Food InsecurityMental healthyoung adultstraumaadverse childhood experiencepsychological distressprecaritymixed-methods

Outcome Measures

Primary Outcomes (1)

  • 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.

    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 Outcomes (3)

  • 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).

Other Outcomes (1)

  • Participants' subjective experience

    3 months after baseline; 6 months after baseline; 12 months after baseline (end of the study)

Study Arms (2)

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.

Other: Food Assistance

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.

Other: Food AssistanceBehavioral: Psychological Follow-Up

Interventions

Weekly food assistance provided to participants for a duration of 12 months, aimed at reducing food insecurity.

Food Assistance Only (Control Group)Food Assistance Plus Psychological Support (Experimental Group)

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.

Food Assistance Plus Psychological Support (Experimental Group)

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Mission Locale site Centre

Paris, 75011, France

Location

Mission Locale site Soleil

Paris, 75013, France

Location

Mission Locale site Avenir

Paris, 75014, France

Location

Mission Locale site Milord

Paris, 75018, France

Location

Mission Locale site Est

Paris, 75019, France

Location

Mission Locale site Pyrénées

Paris, 75020, France

Location

Related Publications (4)

  • 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: 40893605BACKGROUND
  • 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: 37513678BACKGROUND
  • 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: 32174292BACKGROUND
  • 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.

    BACKGROUND

Related Links

MeSH Terms

Conditions

Trauma and Stressor Related DisordersDepressionAnxiety DisordersPsychological Well-BeingWounds and Injuries

Interventions

Food Assistance

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehaviorPersonal Satisfaction

Intervention Hierarchy (Ancestors)

Public AssistanceFinancing, GovernmentFinancing, OrganizedEconomicsHealth Care Economics and Organizations

Study Officials

  • Aziz Essadek, PhD

    Université de Paris Cité

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aziz ESSADEK, PhD

CONTACT

Maud Cappelletti, PhD student

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This study uses a parallel-group interventional design in which participants are randomized (1:1) using a simple randomization sequence. Outcome assessors are blinded to group assignment. The investigator who carries out the randomization procedure will be responsible for the assessments (questionnaires and semi-structured interviews). The control group receives weekly food assistance for 12 months, while the experimental group receives the same food assistance combined with twice-monthly psychological sessions for 6 months. Participants remain in their assigned group throughout the study, with repeated assessments conducted at predefined time points to evaluate changes in food insecurity and psychological well-being (T0: baseline; T1: 3 months after baseline; T2: 6 months after baseline; T3: 12 months after baseline, end of the study). The psychologists who carry out the follow-ups are partners of the Mission Locale but are not part of the research team.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2026

First Posted

February 23, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

May 5, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

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.

Locations