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临床试验/NCT02567500
NCT02567500已完成不适用

Identification of Cognitive and Emotional Factors in Relation to Auditory Hallucinations in Non-psychotic Children

Fondation Lenval2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2015年7月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
Evolution of the score of theory of mind

研究概览

简要总结

The aim of this study is to show presence of cognitive and emotional factors on the beginning and persistence of auditory hallucinations in non-psychotic children. Investigators will describe a significant link between this factors and hallucinations in a sample of non-psychotic children. The results of this sample will be comparing to another group of children of the same age, sex and diagnosis, but without hallucination. Finally, investigators will control the persistence of hallucination on the first group after a six month period.

详细描述

Background: Hallucinations are a common symptom in pediatric population without psychotic syndrome. Vulnerability, co morbidity and risk factor are already been described. Investigators will study the cognitive and emotional factors on the beginning and persistence of auditory hallucinations in non-psychotic children. The goal of the study is to find a social cognition our emotional impairment to explain auditory hallucinations without psychotic symptoms. Methods: Sample of out non-psychotic patients aged six to eighteen years old with auditory hallucinations were recruited with a self report scale created for this study. Mini International Neuropsychiatric Interview (MINI)-kids interview and "psychosis" section od Kiddie-SADS (Schedule for Affective Disorders and Schizophrenia for school age chidlren) were conducted to determine Diagnostic and Statistical Manual of Mental Disorders (DSM) IV diagnoses. All children patient were spend specifics social cognition (NeuroPsychologic assessment NEPSY II) and emotional (ifferential Emotions Scale (DES) IV, Beliefs About Voices Questionnaire Revised (BAVQ-R)) scales. Each child results will be compared to child result of the same age, sex and diagnosis but without hallucination that passed the same specifics scales. All of child will be control after a six month period to evaluate auditory hallucination persistence and diagnosis evolution. The total period of the study will be twelve month.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
6 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Twenty participants included with auditory hallucination:
  • Boy or girl
  • Over six years old and under eighteen years old
  • DSM-IV diagnosis of mood disorder, anxiety, disruptive behavioral disorder, attention deficit hyperactivity disorder, without schizophrenia diagnosis, without mental retardation (Intelligence Quotient (IQ)>70),
  • Parental and child consent, affiliated to social security.
  • Twenty participants included without auditory hallucination:
  • Boy or girl
  • Over six years old and under eighteen years old
  • DSM-IV diagnosis of mood disorder, anxiety, disruptive behavioral disorder, attention deficit hyperactivity disorder, without schizophrenia diagnosis, without mental retardation (IQ>70)
  • Parental and child consent, affiliated to social security.

排除标准

  • schizophrenia diagnosis,
  • neurologic, genetic or neurosensory disorders

研究组 & 干预措施

Patients with auditory hallucination

Experimental

Patients with auditory hallucination:

Evaluation at time 0 and 6 month after of:

  • The social cognitive marker (NeuroPsychologic assessment (NEPSY) II) : theory of mind and affect recognition

  • The emotional marker:

  • Differential Emotion Scale IV (DES IV): emotional individual stability

  • Revised Beliefs About Voices Questionnaire (BAVQ-R): a self report measure of patients' beliefs, emotional and behavior about auditory hallucination.

  • Evaluation of auditory hallucinations persistence with a self report scale using in recruiting criteria.

  • Evaluation of diagnosis with Diagnostic and Statistical Manual of Mental Disorders (DSM) -IV criteria:

  • Mini International Neuropsychiatric Interview (MINI) -Kids

  • "Psychosis" section of Kiddie-SADS

干预措施: Patients with auditory hallucination (Behavioral)

Patients without auditory hallucination

Placebo Comparator

Patients without auditory hallucination:

Evaluation at time 0 and 6 month after of:

  • The social cognitive marker (NEPSY II) : theory of mind and affect recognition

  • The emotional marker:

  • Differential emotion scale IV (DES IV): emotional individual stability

  • Revised Beliefs About Voices Questionnaire (BAVQ-R): a self report measure of patients' beliefs, emotional and behavior about auditory hallucination.

  • Evaluation of auditory hallucinations persistence with a self report scale using in recruiting criteria.

  • Evaluation of diagnosis with Diagnostic and Statistical Manual of Mental Disorders (DSM) -IV criteria:

  • Mini International Neuropsychiatric Interview (MINI) -Kids

  • "Psychosis" section of Kiddie-SADS (Schedule for Affective Disorders and Schizophrenia )

干预措施: Patients without auditory hallucination (Behavioral)

结局指标

主要结局

Evolution of the score of theory of mind

时间窗: Change from baseline 6 month later

The social cognitive marker will be evaluate by NeuroPsychologic assessment NEPSY II for theory of mind

次要结局

  • Evaluation of the score of Psychosis(Change from baseline 6 month later)
  • Evolution of auditory measure of patients' emotional(Change from baseline 6 month later)
  • Evolution of the score of affect recognition(Change from baseline 6 month later)
  • Evolution of the score of auditory hallucinations persistence(Change from baseline 6 month later)
  • Evolution of measure of recognition of the feelings(Change from baseline 6 month later)
  • Evolution of the score of Mental Disorder(Change from baseline 6 month later)
  • Evolution of the score of individual stability(Change from baseline 6 month later)
  • Evolution of Emotional real-life experience of the hallucination(Change from baseline 6 month later)

研究者

发起方
Fondation Lenval
申办方类型
Other
责任方
Sponsor

研究点 (2)

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