French Validation of Schizophrenia Proneness Instrument- Child Youth

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2026-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Cognitive Phenotyping of Severe Psychiatric Disorders (PSYCOG)

NCT05025566

Severe Psychiatric Disorders

NOT_YET_RECRUITING

Investigation of Neurophysiological Markers, Possibly Specific of Two Subforms of Psychotic Disorders

NCT03649581

Schizophrenia

RECRUITING NA

Enhancing the Prospective Prediction of Psychosis

NCT00291200

Schizophrenia Psychotic Disorders

COMPLETED

Psychological Intervention for Persons in the Early Initial Prodromal State

NCT00204087

Schizophrenia Psychosis

UNKNOWN PHASE3

Prospective Cohort Study of a Population at Risk of Psychotic Transition

NCT06539611

At-risk Mental States

ACTIVE_NOT_RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Clinical High Risk for Psychosis (CHR)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SPI-CY assessment

all patients will undergo a SPI-CY interview

Group Type OTHER

Psychiatric and psychological diagnostic tests

Intervention Type DIAGNOSTIC_TEST

French validation of the SPI-CY

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Psychiatric and psychological diagnostic tests

French validation of the SPI-CY

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No