French Validation of Schizophrenia Proneness Instrument- Child Youth
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Psychiatric and psychological diagnostic tests.
- Who it may be relevant to
- Registry conditions: Clinical High Risk for Psychosis (CHR). Basic parameters: 12 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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 test Psychiatric and psychological diagnostic tests
French validation of the SPI-CY
Primary outcome measures
- SPI-CY assessment : Schizophrenia Proneness Instrument - Child and Youth version [Time frame: Day 1]
Secondary outcome measures (5)
- CAARMS assessment : Comprehensive Assessment of At Risk Mental State [Time frame: Day 15 maximum]
- MHASC assessment : Multisensory HAllucination SCale [Time frame: Day 15 maximum]
- PQ16 assessment : Prodromal Questionnaire 16 [Time frame: Day 15 maximum]
- PCA assessment : Perceptual and Cognitive Aberrations [Time frame: Day 15 maximum]
- Audiograph : formalization of visual hallucinations [Time frame: Day 15 maximum]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 3 centers
- CHRU Lille — Lille
- Centre Psychothérapique de Nancy — Nancy
- CH Alpes-Isère — Saint-Egrève
Identifiers
NCT: NCT06649552 · 2024-A01301-46