NCT06869915

Brief Summary

Introduction \& Central question: Psychiatric disorders are highly prevalent in the homeless population, however neurodevelopmental disorders are also at risk of leading to homelessness (Churchard et al., 2018; Casey et al., 2020). Research on this topic is poor in France. This research aims to study the prevalence in France of 3 neurodevelopmental disorders (NDDs) in a homeless population (Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder and Intellectual Developmental Disorder). Methods / approach: A 2 phase approach will be used including a screening phase and a diagnosis phase. This research is a pilot study that will include 150 homeless people, over 2 years. The assessment involves combining the results from standardised self-report tools, direct observation and informant-report, thus guaranteeing an objective and thorough diagnosis. This approach gives a better picture of actual behaviour but also a better understanding of the person's development. OUTCOME: This study will give insight on how to better understand the profile of the homeless population in France, and the prevalence of autism in this population. It will also bring valuable knowledge on how autism and other NDDs can impact one's path in life and lead to homelessness. The results can help develop targeted cares and measures for homeless people with NDDs.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
17mo left

Started Sep 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress34%
Sep 2025Sep 2027

First Submitted

Initial submission to the registry

March 5, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 11, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

September 15, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

August 1, 2025

Status Verified

July 1, 2025

Enrollment Period

1.5 years

First QC Date

March 5, 2025

Last Update Submit

July 29, 2025

Conditions

Keywords

homelessness

Outcome Measures

Primary Outcomes (1)

  • Prevalence (percentage) of ASD, ADHD and IDD in the studied population (homeless people sheltered in accommodation and social rehabilitation centers).

    For each NDD here are the scores and tools used : ASD : * AQ-10 cut-off score * CAT-Q cut-off score(Camouflage of Autistic Traits Questionnaire) * Glasgow questionnaire : standard score deviations * DATHi (DSM-5 Autistic Traits in the Homeless Interview) : cut-off score ADHD: * ADHD Self-report (ASRS) : cut-off score * Diagnostic Interview for Adult ADHD (DUVA-5): cut-off score * ASRS - Observer : cut-off score IDD: * Raven matrices: score * Vineland Adaptive Behaviour Scale (2nd edition): cut-off score

    4 months

Secondary Outcomes (5)

  • Demographic information

    4 months

  • Judicial information

    4 months

  • Medical Record

    4 months

  • Drug abuse

    4 months

  • History of traumatic brain injury, epilepsy and coma

    4 months

Study Arms (1)

Homeless people sheltered in accommodation and social rehabilitation centers

OTHER

Prevalence (percentage) of ASD, ADHD and IDD in the studied population (homeless people sheltered in accommodation and social rehabilitation centers).

Diagnostic Test: Prevalence (percentage) of ASD, ADHD and IDD in the studied population (homeless people sheltered in accommodation and social rehabilitation centers).

Interventions

This study is an observational prospective multi-centric non interventional study. The focus of the study is a homeless population sheltered in accommodation and social rehabilitation centres. The prevalence of neurodevelopmental disorders in this population will be studied.

Homeless people sheltered in accommodation and social rehabilitation centers

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Homeless people sheltered in accommodation and social rehabilitation centers
  • Over 18 years of age
  • Who speak French
  • who have given then written informed consent

You may not qualify if:

  • \- Every person who hasn't given their written informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Vinatier

Lyon, Auvergne-Rhône-Alpes, 69678, France

Location

MeSH Terms

Conditions

Neurodevelopmental Disorders

Interventions

Accommodation, Ocular

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Ocular Physiological Phenomena

Study Officials

  • Caroline DEMILY, MdPh

    VINATIER HOSPITAL

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Every person recruited for the study will undergo a screening phase. If screening is positive, then the person will undergo a diagnostic phase. If screening is negative, the study stops for that person.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2025

First Posted

March 11, 2025

Study Start

September 15, 2025

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

September 30, 2027

Last Updated

August 1, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations