French Validation of Schizophrenia Proneness Instrument- Child Youth

NCT06649552 | Not Yet Recruiting

• 1 other identifier: 2024-A01301-46
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 3

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).

Conditions

Clinical High Risk for Psychosis (CHR)

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  Day 1

Secondary Outcomes (5)

• 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

Study Arms (1)

SPI-CY assessment

OTHER

all patients will undergo a SPI-CY interview

Diagnostic Test: Psychiatric and psychological diagnostic tests

Interventions

Psychiatric and psychological diagnostic tests DIAGNOSTIC_TEST

French validation of the SPI-CY

SPI-CY assessment

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Psychothérapique de Nancy: lead

Study Sites (3)

CHRU Lille

Lille, 59037, France

Location

Centre Psychothérapique de Nancy

Nancy, 54521, France

Location

CH Alpes-Isère

Saint-Egrève, 38120, France

Location

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Florent BERNARDIN

  Centre Psychothérapique de Nancy (CPN)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Florent BERNARDIN

CONTACT

0033 3 83 26 08 63; florent.bernardin@cpn-laxou.com

Tatiana DABROWSKI

CONTACT

unic@cpn-laxou.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: October 18, 2024
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share

Locations

FR (3)