MISAPSY: Childhood Maltreatment, Food Insecurity, Psychological Distress and Professional Integration Among Socioeconomically Disadvantaged Young Adults

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-25
SponsorUniversity of Lorraine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Food Assistance

    Other intervention

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

  • Psychological Follow-Up

    Behavioral

    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.

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Food Assistance Only (Control Group)Active comparator 1 intervention
Group B: Food Assistance Plus Psychological Support (Experimental Group)Experimental treatment 2 interventions

Trial outcomes

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.

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)

Secondary outcomes

1

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)
2

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).
3

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).

Other outcomes

1

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)

Sponsors and contacts

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