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临床试验/NCT06649552
NCT06649552招募中不适用

French Validation of Schizophrenia Proneness Instrument- Child Youth

Centre Psychothérapique de Nancy6 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2025年2月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
52
试验地点
6
主要终点
SPI-CY assessment : Schizophrenia Proneness Instrument - Child and Youth version

研究概览

简要总结

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).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
12 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

研究组 & 干预措施

SPI-CY assessment

Other

all patients will undergo a SPI-CY interview

干预措施: Psychiatric and psychological diagnostic tests (Diagnostic Test)

结局指标

主要结局

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

时间窗: Day 1

次要结局

  • PCA assessment : Perceptual and Cognitive Aberrations(Day 15 maximum)
  • Audiograph : formalization of visual hallucinations(Day 15 maximum)
  • CAARMS assessment : Comprehensive Assessment of At Risk Mental State(Day 15 maximum)
  • MHASC assessment : Multisensory HAllucination SCale(Day 15 maximum)
  • PQ16 assessment : Prodromal Questionnaire 16(Day 15 maximum)

研究者

发起方
Centre Psychothérapique de Nancy
申办方类型
Other
责任方
Sponsor

研究点 (6)

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