NCT06649552 French Validation of Schizophrenia Proneness Instrument- Child Youth
| NCT ID | NCT06649552 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Psychothérapique de Nancy |
| Condition | Clinical High Risk for Psychosis (CHR) |
| Study Type | INTERVENTIONAL |
| Enrollment | 52 participants |
| Start Date | 2025-02-13 |
| Primary Completion | 2027-01-13 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 52 participants in total. It began in 2025-02-13 with a primary completion date of 2027-01-13.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Florent BERNARDIN
PRINCIPAL INVESTIGATOR
Centre Psychothérapique de Nancy (CPN)
Frequently Asked Questions
Who can join the NCT06649552 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 17 Years, studying Clinical High Risk for Psychosis (CHR). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06649552 currently recruiting?
Yes, NCT06649552 is actively recruiting participants. Contact the research team at florent.bernardin@cpn-laxou.com for enrollment information.
Where is the NCT06649552 trial being conducted?
This trial is being conducted at Lille, France, Nancy, France, Saint-Egrève, France.
Who is sponsoring the NCT06649552 clinical trial?
NCT06649552 is sponsored by Centre Psychothérapique de Nancy. The principal investigator is Florent BERNARDIN at Centre Psychothérapique de Nancy (CPN). The trial plans to enroll 52 participants.