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NCT Number: NCT06649552

French Validation of Schizophrenia Proneness Instrument- Child Youth

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).

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Key information

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU Lille, Lille, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psychiatric and psychological diagnostic tests

Diagnostic Test

French validation of the SPI-CY

Primary outcomes

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

    Time frame: Day 1

Secondary outcomes

  1. CAARMS assessment : Comprehensive Assessment of At Risk Mental State

    Time frame: Day 15 maximum

  2. MHASC assessment : Multisensory HAllucination SCale

    Time frame: Day 15 maximum

  3. PQ16 assessment : Prodromal Questionnaire 16

    Time frame: Day 15 maximum

  4. PCA assessment : Perceptual and Cognitive Aberrations

    Time frame: Day 15 maximum

  5. Audiograph : formalization of visual hallucinations

    Time frame: Day 15 maximum

Study contacts

Contact information is provided by the study sponsor or research team.

Florent BERNARDIN

CONTACT

[email protected]

0033 3 83 26 08 63

Tatiana DABROWSKI

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Centre Psychothérapique de Nancy

Other

Registry information

Acronym: SPI-CY-Fr

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 18, 2024
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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