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French Validation of Schizophrenia Proneness Instrument- Child Youth

French Validation of Schizophrenia Proneness Instrument- Child Youth

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06649552
Acronym
SPI-CY-Fr
Enrollment
52
Registered
2024-10-18
Start date
2025-02-13
Completion date
2027-02-01
Last updated
2026-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clinical High Risk for Psychosis (CHR)

Keywords

SPI-CY, Basic Symptoms, Psychosis, Clinical High Risk, Ultra High Risk

Brief 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). 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).

Interventions

DIAGNOSTIC_TESTPsychiatric and psychological diagnostic tests

French validation of the SPI-CY

Sponsors

Centre Psychothérapique de Nancy
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No

Inclusion criteria

: * 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.

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
SPI-CY assessment : Schizophrenia Proneness Instrument - Child and Youth versionDay 1

Secondary

MeasureTime frame
CAARMS assessment : Comprehensive Assessment of At Risk Mental StateDay 15 maximum
MHASC assessment : Multisensory HAllucination SCaleDay 15 maximum
PQ16 assessment : Prodromal Questionnaire 16Day 15 maximum
PCA assessment : Perceptual and Cognitive AberrationsDay 15 maximum
Audiograph : formalization of visual hallucinationsDay 15 maximum

Countries

France

Contacts

CONTACTFlorent BERNARDIN
florent.bernardin@cpn-laxou.com0033 3 83 26 08 63
CONTACTTatiana DABROWSKI
unic@cpn-laxou.com
PRINCIPAL_INVESTIGATORFlorent BERNARDIN

Centre Psychothérapique de Nancy (CPN)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 25, 2026