French Validation of Schizophrenia Proneness Instrument- Child Youth (SPI-CY-Fr)

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 Overview

• Status: Recruiting
• Conditions: Clinical High Risk for Psychosis (CHR)
• Intervention / Treatment: Diagnostic test: Psychiatric and psychological diagnostic tests

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Florent BERNARDIN; Phone Number: 0033 3 83 26 08 63; Email: florent.bernardin@cpn-laxou.com
• Study Contact Backup: Name: Tatiana DABROWSKI; Email: unic@cpn-laxou.com

Study Locations

• France
  • Lille, France, 59037
    • Not yet recruiting
    • CHRU Lille
    • Contact: Renaud JARDRI; Phone Number: 0033 3 20 44 59 62; Email: renaud.jardri@chru-lille.fr
  • Nancy, France, 54521
    • Recruiting
    • Centre Psychothérapique de Nancy
    • Contact: Florent BERNARDIN; Phone Number: 0033 3 83 26 08 63; Email: florent.bernardin@cpn-laxou.com
  • Saint-Egrève, France, 38120
    • Recruiting
    • CH Alpes-Isère
    • Contact: Clément DONDÉ; Phone Number: 0033 4 76 56 42 56; Email: clement.donde@univ-grenoble-alpes.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: SPI-CY assessment; all patients will undergo a SPI-CY interview	Diagnostic test: Psychiatric and psychological diagnostic tests; French validation of the SPI-CY

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
SPI-CY assessment : Schizophrenia Proneness Instrument - Child and Youth version	Day 1

Secondary Outcome Measures

Outcome Measure	Time Frame
CAARMS assessment : Comprehensive Assessment of At Risk Mental State	Day 15 maximum
MHASC assessment : Multisensory HAllucination SCale	Day 15 maximum
PQ16 assessment : Prodromal Questionnaire 16	Day 15 maximum
PCA assessment : Perceptual and Cognitive Aberrations	Day 15 maximum
Audiograph : formalization of visual hallucinations	Day 15 maximum

Collaborators and Investigators

• Sponsor: Centre Psychothérapique de Nancy
• Investigators: Principal Investigator: Florent BERNARDIN, Centre Psychothérapique de Nancy (CPN)

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2025
• Primary Completion (Estimated): January 13, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: October 16, 2024
• First Submitted That Met QC Criteria: October 17, 2024
• First Posted (Actual): October 18, 2024

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Psychosis; Clinical High Risk; Ultra High Risk; Basic Symptoms; SPI-CY
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Psychotic Disorders
• Other Study ID Numbers: 2024-A01301-46

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No