Clinical High Risk for Psychosis (CHR)SPI-CY-FrNCT06649552
French Validation of Schizophrenia Proneness Instrument- Child Youth
A study testing Psychiatric and psychological diagnostic tests in people with Clinical High Risk for Psychosis (CHR), run by Centre Psychothérapique de Nancy at 3 sites in France.
Trial summary
The clinical concept of a at risk mental state of developing psychosis is based on the identification of attenuated psychotic symptoms during the prodromal phase of psychoses (Schmidt et al., 2015). Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Clinical High Risk for Psychosis (CHR)
- What is being tested?
- Psychiatric and psychological diagnostic tests
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 3 sitesFrance
- Study dates
- 13 Feb 2025to 1 Feb 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients (men or women) followed at one of the 3 following structures in France : CLIP-Ado Nancy, CH Alpes-Isère, CHRU Lille for a suspected mental state at risk of developing psychosis, as determined by the CAARMS scale and/or the SPI-CY scale.
- Age between 12 and 17 years and 11 months
- Affiliation with a social security scheme or beneficiary of such a scheme.
- Native language: French.
- Adolescents who have been informed of the study, have received the study information note and have not objected to participating in the study
- At least one of the holders of parental authority having been informed of the study, having received the relevant information note and not having objected to the adolescent participation
- Consent to audio recording of the SPI-CY scale administration: for the adolescent and at least one parent.
Who cannot join
- Pregnant woman, parturient or nursing mother
- Person deprived of liberty by judicial or administrative decision
- Person in a life-threatening emergency
- Impairment of the subject that makes it difficult, if not impossible, to participate in the trial or to understand the information provided.
- Abuse or dependence on any substance according to DSM V criteria, excluding cannabis
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Tatiana DABROWSKI contact
France3 sites, 3 recruiting
- Not yet recruiting
CHRU Lille
Lille, 59037
Renaud JARDRI, 0033 3 20 44 59 62, renaud.jardri@chru-lille.fr
- Recruiting
Centre Psychothérapique de Nancy
Nancy, 54521
Florent BERNARDIN, 0033 3 83 26 08 63, florent.bernardin@cpn-laxou.com
- Recruiting
CH Alpes-Isère
Saint-Egrève, 38120
Clément DONDÉ, 0033 4 76 56 42 56, clement.donde@univ-grenoble-alpes.fr
About this study
The clinical concept of a at risk mental state of developing psychosis is based on the identification of attenuated psychotic symptoms during the prodromal phase of psychoses (Schmidt et al., 2015). Early detection and support of these symptoms can delay the risk of transition to a first psychotic episode (van der Gaag, van den Berg, \& Ising, 2019).
The Basic Symptom approach enables detection at the earliest stage of the prodromal phase. It postulates that subtle, subjective manifestations predating attenuated psychotic symptoms are present very early in the prodromal phase of psychosis and also have predictive value for the risk of developing psychosis (F. Schultze-Lutter, 2009). Basic symptoms are assessed using the Schizophrenia Proneness Instrument, available in an adult (SPI-A) and child/adolescent (SPI-CY) version. These scales are part of the international recommendations for the assessment of patients with a Clinical State at High Risk of Psychosis (CHR-P) (Schmidt et al., 2015; F Schultze-Lutter et al., 2015). The SPI-A is validated in French under the name "Outil d'Evaluation du Risque Schizophrénique version adulte (OERS-A)" (Schultze-Lutter et al., 2007. French translation by JR. Teyssier with the collaboration of F. Gamma and P. Loulergue), but no French version of the SPI-CY has yet been validated.
Read more
In collaboration with Dr. Frauke Schultze-Lutter, the investigators have recently published a French translation of the SPI-CY (Schizophrenia Predisposition Instrument - Version for Children and Adolescents, F. Schultze-Lutter, M. Marshall, E. Koch, 2021. French translation by F. Bernardin and C. Dondé). This French translation must now be validated to ensure the inter-rater fidelity of the interview.
We therefore propose to study the inter-rater reliability of the French version of the SPI-CY by comparing ratings between clinicians who have undergone training in basic symptoms and in administering the SPI-A and SPI-CY tools by Dr. Schultze-Lutter. This validation will be carried out by comparing, on the one hand, the rating of the SPI-CY by a clinician A who has administered it to the patient and, on the other hand, the blind rating of a clinician B on the basis of the interview recorded by clinician A with his patient.
The investigators will also explore the links between the SPI-CY and other clinical scales such as the Multisensory Hallucination SCale (MHASC) (Demeulemeester et al., 2015), the Prodromal Questionnaire 16 (PQ-16) (Lejuste et al., 2021), the Audiograph (Giersch, Huard, Park, \& Rosen, 2021) and the Perceptual and Cognitive Aberrations (PCA) (McDonald et al., 2019).
- Conditions
- Clinical High Risk for Psychosis (CHR)
- Being tested
- Psychiatric and psychological diagnostic tests
- Keywords
- SPI-CY, Basic Symptoms, Psychosis, Clinical High Risk, Ultra High Risk
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychiatric and psychological diagnostic testsDiagnostic test
French validation of the SPI-CY
| Study group | Role | What they receive |
|---|---|---|
| SPI-CY assessment | Other | all patients will undergo a SPI-CY interview Receives: Diagnostic Test: Psychiatric and psychological diagnostic tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
SPI-CY assessment : Schizophrenia Proneness Instrument - Child and Youth version
Measured: Day 1
Secondary outcomes (5)
CAARMS assessment : Comprehensive Assessment of At Risk Mental State
Measured: Day 15 maximum
MHASC assessment : Multisensory HAllucination SCale
Measured: Day 15 maximum
PQ16 assessment : Prodromal Questionnaire 16
Measured: Day 15 maximum
PCA assessment : Perceptual and Cognitive Aberrations
Measured: Day 15 maximum
Audiograph : formalization of visual hallucinations
Measured: Day 15 maximum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start13 Feb 2025
- Primary completion13 Jan 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical High Risk for Psychosis (CHR)Studies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Psychothérapique de Nancy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florent BERNARDIN, Principal investigator, Centre Psychothérapique de Nancy (CPN)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06649552
- Sponsor's protocol ID
- 2024-A01301-46
- Acronym
- SPI-CY-Fr
- Status last verified
- Apr 2026
- First submitted
- 16 Oct 2024
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- French Validation of Schizophrenia Proneness Instrument- Child Youth
- ClinicalTrials.gov ID
- NCT06649552
- Acronym / sponsor ID
- SPI-CY-Fr / 2024-A01301-46
- Conditions
- Clinical High Risk for Psychosis (CHR)
- Keywords
- SPI-CY, Basic Symptoms, Psychosis, Clinical High Risk, Ultra High Risk
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Centre Psychothérapique de NancyUniversity, hospital or other
- Study start
- 13 Feb 2025 (actual)
- Primary completion
- 13 Jan 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 18 Oct 2024 (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.
The clinical concept of a at risk mental state of developing psychosis is based on the identification of attenuated psychotic symptoms during the prodromal phase of psychoses (Schmidt et al., 2015). Early detection and support of these symptoms can delay the risk of transition to a first psychotic episode (van der Gaag, van den Berg, \& Ising, 2019).
The Basic Symptom approach enables detection at the earliest stage of the prodromal phase. It postulates that subtle, subjective manifestations predating attenuated psychotic symptoms are present very early in the prodromal phase of psychosis and also have predictive value for the risk of developing psychosis (F. Schultze-Lutter, 2009). Basic symptoms are assessed using the Schizophrenia Proneness Instrument, available in an adult (SPI-A) and child/adolescent (SPI-CY) version. These scales are part of the international recommendations for the assessment of patients with a Clinical State at High Risk of Psychosis (CHR-P) (Schmidt et al., 2015; F Schultze-Lutter et al., 2015). The SPI-A is validated in French under the name "Outil d'Evaluation du Risque Schizophrénique version adulte (OERS-A)" (Schultze-Lutter et al., 2007. French translation by JR. Teyssier with the collaboration of F. Gamma and P. Loulergue), but no French version of the SPI-CY has yet been validated.
In collaboration with Dr. Frauke Schultze-Lutter, the investigators have recently published a French translation of the SPI-CY (Schizophrenia Predisposition Instrument - Version for Children and Adolescents, F. Schultze-Lutter, M. Marshall, E. Koch, 2021. French translation by F. Bernardin and C. Dondé). This French translation must now be validated to ensure the inter-rater fidelity of the interview.
We therefore propose to study the inter-rater reliability of the French version of the SPI-CY by comparing ratings between clinicians who have undergone training in basic symptoms and in administering the SPI-A and SPI-CY tools by Dr. Schultze-Lutter. This validation will be carried out by comparing, on the one hand, the rating of the SPI-CY by a clinician A who has administered it to the patient and, on the other hand, the blind rating of a clinician B on the basis of the interview recorded by clinician A with his patient.
The investigators will also explore the links between the SPI-CY and other clinical scales such as the Multisensory Hallucination SCale (MHASC) (Demeulemeester et al., 2015), the Prodromal Questionnaire 16 (PQ-16) (Lejuste et al., 2021), the Audiograph (Giersch, Huard, Park, \& Rosen, 2021) and the Perceptual and Cognitive Aberrations (PCA) (McDonald et al., 2019).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SPI-CY assessment | Other | Diagnostic Test: Psychiatric and psychological diagnostic testsall patients will undergo a SPI-CY interview |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Patients (men or women) followed at one of the 3 following structures in France : CLIP-Ado Nancy, CH Alpes-Isère, CHRU Lille for a suspected mental state at risk of developing psychosis, as determined by the CAARMS scale and/or the SPI-CY scale.
- Age between 12 and 17 years and 11 months
- Affiliation with a social security scheme or beneficiary of such a scheme.
- Native language: French.
- Adolescents who have been informed of the study, have received the study information note and have not objected to participating in the study
Key exclusion criteria (5 listed)
- Pregnant woman, parturient or nursing mother
- Person deprived of liberty by judicial or administrative decision
- Person in a life-threatening emergency
- Impairment of the subject that makes it difficult, if not impossible, to participate in the trial or to understand the information provided.
- Abuse or dependence on any substance according to DSM V criteria, excluding cannabis
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 |
|---|---|---|
| Psychiatric and psychological diagnostic testsFrench validation of the SPI-CY | Diagnostic test | SPI-CY assessment |
Primary outcome
SPI-CY assessment : Schizophrenia Proneness Instrument - Child and Youth version
Time frame: Day 1
5 secondary outcomes
CAARMS assessment : Comprehensive Assessment of At Risk Mental State
Time frame: Day 15 maximum
MHASC assessment : Multisensory HAllucination SCale
Time frame: Day 15 maximum
PQ16 assessment : Prodromal Questionnaire 16
Time frame: Day 15 maximum
PCA assessment : Perceptual and Cognitive Aberrations
Time frame: Day 15 maximum
Audiograph : formalization of visual hallucinations
Time frame: Day 15 maximum
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 24 Apr 2026.
- Individual participant dataSharing planned: Yes
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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.
Tatiana DABROWSKI contact
Florent BERNARDIN principal investigator
Centre Psychothérapique de Nancy (CPN)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychiatric and psychological diagnostic tests in people with Clinical High Risk for Psychosis (CHR), run by Centre Psychothérapique de Nancy at 3 sites 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 7 inclusion and 5 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 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Florent BERNARDIN (0033 3 83 26 08 63, florent.bernardin@cpn-laxou.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SPI-CY assessment : Schizophrenia Proneness Instrument - Child and Youth version (time frame: Day 1). 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 24 Apr 2026.