Clinical trial NCT06649552: French Validation of Schizophrenia Proneness Instrument- Child Youth
Official title: French Validation of Schizophrenia Proneness Instrument- Child Youth
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Clinical High Risk for Psychosis (CHR)
Keywords: SPI-CY
Basic Symptoms
Psychosis
Clinical High Risk
Ultra High Risk
Lead sponsor: Centre Psychothérapique de Nancy
Sponsor class: OTHER
First posted: 2024-10-18
Enrollment: 52
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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).


Eligibility criteria: 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

Primary outcomes:
measure: SPI-CY assessment : Schizophrenia Proneness Instrument - Child and Youth version
timeFrame: Day 1
Secondary outcomes:
measure: CAARMS assessment : Comprehensive Assessment of At Risk Mental State
timeFrame: Day 15 maximum
measure: MHASC assessment : Multisensory HAllucination SCale
timeFrame: Day 15 maximum
measure: PQ16 assessment : Prodromal Questionnaire 16
timeFrame: Day 15 maximum
measure: PCA assessment : Perceptual and Cognitive Aberrations
timeFrame: Day 15 maximum
measure: Audiograph : formalization of visual hallucinations
timeFrame: Day 15 maximum
Other outcomes:
Locations:
city: Lille
country: France
facility: CHRU Lille
city: Nancy
country: France
facility: Centre Psychothérapique de Nancy
city: Saint-Egrève
country: France
facility: CH Alpes-Isère
Study officials:
affiliation: Centre Psychothérapique de Nancy (CPN)
name: Florent BERNARDIN
role: PRINCIPAL_INVESTIGATOR
References: