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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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

unic@cpn-laxou.com

France3 sites, 3 recruiting
  • CHRU Lille

    Lille, 59037

    Renaud JARDRI, 0033 3 20 44 59 62, renaud.jardri@chru-lille.fr

    Not yet 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

    Recruiting

Other trials in France

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).

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 groups in NCT06649552
Study groupRoleWhat they receive
SPI-CY assessmentOtherall 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.

  1. SPI-CY assessment : Schizophrenia Proneness Instrument - Child and Youth version

    Measured: Day 1

Secondary outcomes (5)
  1. CAARMS assessment : Comprehensive Assessment of At Risk Mental State

    Measured: Day 15 maximum

  2. MHASC assessment : Multisensory HAllucination SCale

    Measured: Day 15 maximum

  3. PQ16 assessment : Prodromal Questionnaire 16

    Measured: Day 15 maximum

  4. PCA assessment : Perceptual and Cognitive Aberrations

    Measured: Day 15 maximum

  5. 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.

  1. First posted18 Oct 2024
  2. Study start13 Feb 2025
  3. Primary completion13 Jan 2027 (estimated)
  4. Study completion1 Feb 2027 (estimated)

Resources

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)
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

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.

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