Neurodevelopmental DisordersPRECA'TNDNCT06869915
Homelessness and Prevalence of Neurodevelopmental Disorders
A study testing Prevalence (percentage) of ASD, ADHD and IDD in the studied population (homeless people sheltered in accommodation and social rehabilitation centers). in people with Neurodevelopmental Disorders, run by Hôpital le Vinatier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Neurodevelopmental Disorders
- What is being tested?
- Prevalence (percentage) of ASD, ADHD and IDD in the studied population (homeless people sheltered in accommodation and social rehabilitation centers).
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 9 Mar 2026to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Homeless people sheltered in accommodation and social rehabilitation centers
- Over 18 years of age
- Who speak French
- who have given then written informed consent
Who cannot join
- Every person who hasn't given their written informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hopital Vinatier
Lyon, Auvergne-Rhône-Alpes, 69678
DEMILY MD CAROLINE, PH, 0033437915163, caroline.demily@ch-le-vinatier.fr
VIAL VERONIQUE, 0033437915531, veronique.vial@ch-le-vinatier.fr
About this study
Official title: Prevalence of Neurodevelopmental Disorders in a Homeless Population - Pilot Study
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.
Read the detailed description
Scientific justification : The main neurodevelopmental disorders (NDDs) are Autism Spectrum Disorder (ASD), Attention-Deficit/Hyperactivity Disorder (ADHD), Intellectual Disability (ID), Specific Learning Disorders and Neurodevelopmental Motor Disorders. This study will focus on three NDDs: ASD, ADHD and ID. Cleaton \& Kirby (2018) point out an accumulation and adversity problematic: people with NDDs would accumulate problems over time "in a cascading and cumulative manner" that would lead to adverse medical, psychological and psychosocial outcomes. Many studies have shown the poor outcomes in NDDs. People with ADHD have higher risks of imprisonment (Young \& Thome, 2011), poor educational achievement (Fleming et al., 2017), thus unemployment (Halmøy et al., 2009), leading to poor quality of life (Agarwal et al., 2012). ASD has also been linked to unemployment (Bush \& Tassé, 2017) or at least to low earnings (Roux et al., 2013), leading to lower quality of life (Ikeda et al., 2014). Unsurprisingly, ID has also been showed to lead to poorer quality of life (Simões \& Santos, 2016), because of the higher risk of risky behaviours (Fogden et al., 2016). Thus, all these reasons can lead to social isolation, difficulties in establishing independent living and vulnerability. Homelessness can arise from vulnerability, as much as it can cause it. Homelessness refers to rough sleeping (to sleep in the open air or in places not intended for human habitation, Crisis, 2017.), but also to people who sleep in adapted sleeping places but who do not have any official title to the accommodation (Fazel et al., 2014). A recent French study (Laporte et al., 2018) concluded that more than 30% of homeless people suffer from mental health disorder (13.2% would have psychosis, 12.3% severe anxiety disorder, 6.7% severe mood disorder). There is an increasing number of studies linking mental health and homelessness, however research on NDDs and homelessness is still rather poor. Two British studies have found a high prevalence of ASD among homeless adults. They explain this prevalence by the difficulty for these people to get and keep a job (Churchard et al., 2018; Kargas et al., 2019). Kargas et al., 2019 have found that 18.5% of their homeless population presented with scores superior to 7 at the AQ-10, consistent with high levels of autistic traits. A prospective study has shown that out of 135 children with ADHD, 23.9% have known homelessness at least once in their adult life (García Murillo et al., 2016). Riglin et al., (2023) explain that 20% of young socially precarious adults would suffer from ADHD. Durbin et al., (2018) claim that the prevalence of ID in a homeless population would be between 12 and 39%, this is corroborated by Brown \& McCann., (2021) who point out that 10 to 39% of homeless people would have an ID. These international studies point out the probable links between homelessness and NDDs, however this field of research is lacking in France.
Main aim of the study : to study the prevalence of the following 3 NDDs (ASD, ADHD, IDD) in a homeless population received in accommodation and social rehabilitation centres
Secondary aims :
- To compare the social, demographic, medical and judicial characteristics of homeless people with NDD and homeless people without NDD.
- To research the frequency of traumatic brain injury, coma and epilepsy in this homeless NDD population.
Methodology :
This study is an observational prospective multi-centric non interventional study.
- Pre-inclusion: a neuropsychologist will give all the information concerning the study to the patients.
- Screening :
- 1st Visit (V1) (1h30) : carried out by a neuropsychologist : written and signed consent for the study and thorough screening for NDDs
- 2nd visit (V2) (1h30) : carried out by a psychiatrist only after a positive screening for one or more NDDs. The psychiatrist will then carry out a developmental anamnesis and then carry out the necessary diagnostic tools.
- Visit with a social worker (45 min): carried out by the psychiatrist or the neuropsychologist in order to collect more specific information on the daily life of the person and help in the diagnostic process.
- End of the research and diagnostic announcement (V3): (45 min), carried out by the psychiatrist, with the participants who did V1 and V2. The psychiatrist will give the results and the diagnosis if pertinent. Specific care and health issues will be discussed.
Population studied: Homeless people sheltered in accommodation and social rehabilitation centres
- Conditions
- Neurodevelopmental Disorders
- Being tested
- Prevalence (percentage) of ASD, ADHD and IDD in the studied population (homeless people sheltered in accommodation and social rehabilitation centers).
- Keywords
- homelessness
- Medical subject headings
- Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevalence (percentage) of ASD, ADHD and IDD in the studied population (homeless people sheltered in accommodation and social rehabilitation centers).Diagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Diagnostic Test: Prevalence (percentage) of ASD, ADHD and IDD in the studied population (homeless people sheltered in accommodation and social rehabilitation centers). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 months
Secondary outcomes (5)
Demographic information
Age, education, professional career, time without a home and duration of homelessness The measures will be in number of weeks, months or years
Measured: 4 months
Judicial information
Record of conviction, sentences and imprisonment
Measured: 4 months
Medical Record
Medical treatments, care, mental health issues
Measured: 4 months
Drug abuse
History of drug abuse, which drugs, quantities
Measured: 4 months
History of traumatic brain injury, epilepsy and coma
History of traumatic brain injury (yes / no); coma (yes /no); epilepsy (yes / no)
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start9 Mar 2026
- Primary completion1 Apr 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurodevelopmental DisordersStudies of the same condition, open and under way.
- More trials run by Hôpital le VinatierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caroline DEMILY, MdPh, Principal investigator, VINATIER HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06869915
- Sponsor's protocol ID
- 2024-A01216-41
- Acronym
- PRECA'TND
- Status last verified
- Jun 2026
- First submitted
- 5 Mar 2025
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Neurodevelopmental Disorders in a Homeless Population - Pilot Study
- ClinicalTrials.gov ID
- NCT06869915
- Acronym / sponsor ID
- PRECA'TND / 2024-A01216-41
- Conditions
- Neurodevelopmental Disorders
- Keywords
- homelessness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Study start
- 9 Mar 2026 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Scientific justification : The main neurodevelopmental disorders (NDDs) are Autism Spectrum Disorder (ASD), Attention-Deficit/Hyperactivity Disorder (ADHD), Intellectual Disability (ID), Specific Learning Disorders and Neurodevelopmental Motor Disorders. This study will focus on three NDDs: ASD, ADHD and ID. Cleaton \& Kirby (2018) point out an accumulation and adversity problematic: people with NDDs would accumulate problems over time "in a cascading and cumulative manner" that would lead to adverse medical, psychological and psychosocial outcomes. Many studies have shown the poor outcomes in NDDs. People with ADHD have higher risks of imprisonment (Young \& Thome, 2011), poor educational achievement (Fleming et al., 2017), thus unemployment (Halmøy et al., 2009), leading to poor quality of life (Agarwal et al., 2012). ASD has also been linked to unemployment (Bush \& Tassé, 2017) or at least to low earnings (Roux et al., 2013), leading to lower quality of life (Ikeda et al., 2014). Unsurprisingly, ID has also been showed to lead to poorer quality of life (Simões \& Santos, 2016), because of the higher risk of risky behaviours (Fogden et al., 2016). Thus, all these reasons can lead to social isolation, difficulties in establishing independent living and vulnerability. Homelessness can arise from vulnerability, as much as it can cause it. Homelessness refers to rough sleeping (to sleep in the open air or in places not intended for human habitation, Crisis, 2017.), but also to people who sleep in adapted sleeping places but who do not have any official title to the accommodation (Fazel et al., 2014). A recent French study (Laporte et al., 2018) concluded that more than 30% of homeless people suffer from mental health disorder (13.2% would have psychosis, 12.3% severe anxiety disorder, 6.7% severe mood disorder). There is an increasing number of studies linking mental health and homelessness, however research on NDDs and homelessness is still rather poor. Two British studies have found a high prevalence of ASD among homeless adults. They explain this prevalence by the difficulty for these people to get and keep a job (Churchard et al., 2018; Kargas et al., 2019). Kargas et al., 2019 have found that 18.5% of their homeless population presented with scores superior to 7 at the AQ-10, consistent with high levels of autistic traits. A prospective study has shown that out of 135 children with ADHD, 23.9% have known homelessness at least once in their adult life (García Murillo et al., 2016). Riglin et al., (2023) explain that 20% of young socially precarious adults would suffer from ADHD. Durbin et al., (2018) claim that the prevalence of ID in a homeless population would be between 12 and 39%, this is corroborated by Brown \& McCann., (2021) who point out that 10 to 39% of homeless people would have an ID. These international studies point out the probable links between homelessness and NDDs, however this field of research is lacking in France.
Main aim of the study : to study the prevalence of the following 3 NDDs (ASD, ADHD, IDD) in a homeless population received in accommodation and social rehabilitation centres
Secondary aims :
- To compare the social, demographic, medical and judicial characteristics of homeless people with NDD and homeless people without NDD.
- To research the frequency of traumatic brain injury, coma and epilepsy in this homeless NDD population.
Methodology :
This study is an observational prospective multi-centric non interventional study.
- Pre-inclusion: a neuropsychologist will give all the information concerning the study to the patients.
- Screening :
- 1st Visit (V1) (1h30) : carried out by a neuropsychologist : written and signed consent for the study and thorough screening for NDDs
- 2nd visit (V2) (1h30) : carried out by a psychiatrist only after a positive screening for one or more NDDs. The psychiatrist will then carry out a developmental anamnesis and then carry out the necessary diagnostic tools.
- Visit with a social worker (45 min): carried out by the psychiatrist or the neuropsychologist in order to collect more specific information on the daily life of the person and help in the diagnostic process.
- End of the research and diagnostic announcement (V3): (45 min), carried out by the psychiatrist, with the participants who did V1 and V2. The psychiatrist will give the results and the diagnosis if pertinent. Specific care and health issues will be discussed.
Population studied: Homeless people sheltered in accommodation and social rehabilitation centres
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Homeless people sheltered in accommodation and social rehabilitation centers | Other | Diagnostic Test: Prevalence (percentage) of ASD, ADHD and IDD in the studied population (homeless people sheltered in accommodation and social rehabilitation centers).Prevalence (percentage) of ASD, ADHD and IDD in the studied population (homeless people sheltered in accommodation and social rehabilitation centers). |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Homeless people sheltered in accommodation and social rehabilitation centers
- Over 18 years of age
- Who speak French
- who have given then written informed consent
Key exclusion criteria (1 listed)
- Every person who hasn't given their written informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prevalence (percentage) of ASD, ADHD and IDD in the studied population (homeless people sheltered in accommodation and social rehabilitation centers).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. | Diagnostic test | Homeless people sheltered in accommodation and social rehabilitation centers |
Primary outcome
Prevalence (percentage) of ASD, ADHD and IDD in the studied population (homeless people sheltered in accommodation and social rehabilitation centers).
Time frame: 4 months
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
5 secondary outcomes
Demographic information
Time frame: 4 months
Judicial information
Time frame: 4 months
Medical Record
Time frame: 4 months
Drug abuse
Time frame: 4 months
History of traumatic brain injury, epilepsy and coma
Time frame: 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Caroline DEMILY, MdPh principal investigator
VINATIER HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prevalence (percentage) of ASD, ADHD and IDD in the studied population (homeless people sheltered in accommodation and social rehabilitation centers). in people with Neurodevelopmental Disorders, run by Hôpital le Vinatier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gabrielle CHESNOY (0033437915380, gabrielle.chesnoy@ch-le-vinatier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence (percentage) of ASD, ADHD and IDD in the studied population (homeless people sheltered in accommodation and social rehabilitation centers). (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.