The Physalis Child : Identification of Cognitive and Emotional Factors

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Auditory Hallucinations

Intervention / Treatment
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* Behavioral: Patients with auditory hallucination
* Behavioral: Patients without auditory hallucination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Twenty participants included with auditory hallucination: Boy or girl French 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 French, 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. Exclusion Criteria: schizophrenia diagnosis, neurologic, genetic or neurosensory disorders

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with auditory hallucination<br>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 | Behavioral: Patients with auditory hallucination<br>* Patients with auditory hallucination (20 for each arm): 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 DSM-IV criteria: MINI-Kids Psychosis section of Kiddie-SADS<br>|
| Placebo Comparator: Patients without auditory hallucination<br>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 ) | Behavioral: Patients without auditory hallucination<br>* Patients without auditory hallucination (20 for each arm): 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 DSM-IV criteria: MINI-Kids Psychosis section of Kiddie-SADS<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of the score of theory of mind | The social cognitive marker will be evaluate by NeuroPsychologic assessment NEPSY II for theory of mind | Change from baseline 6 month later | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of the score of auditory hallucinations persistence | Evaluation of auditory hallucinations persistence with a self report scale using in recruiting criteria. | Change from baseline 6 month later | 
| Evolution of the score of Mental Disorder | Evaluation of diagnosis of Mental Disorder with Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV criteria using MINI-Kids (Mini International Neuropsychiatric Interview ) | Change from baseline 6 month later | 
| Evaluation of the score of Psychosis | Evaluation of diagnosis of psychosis with DSM-IV (Diagnostic and Statistical Manual of Mental Disorders ) criteria using Psychosis section of Kiddie-SADS (Schedule for Affective Disorders and Schizophrenia for school age chidlren) | Change from baseline 6 month later | 
| Evolution of the score of individual stability | The evaluation of the the emotional marker will be performed with the Differential emotion scale IV (DES IV): emotional individual stability | Change from baseline 6 month later | 
| Evolution of measure of recognition of the feelings | The measure of recognition of the feelings will be performed by the score: The social cognitive marker (NEPSY II) | Change from baseline 6 month later | 
| Evolution of auditory measure of patients' emotional | The auditory measure will be performed by the score: The social cognitive marker (NEPSY II) | Change from baseline 6 month later | 
| Evolution of Emotional real-life experience of the hallucination | The Emotional real-life experience of the hallucination will be performed by the score: The Revised Beliefs About Voices Questionnaire (BAVQ-R) | Change from baseline 6 month later | 
| Evolution of the score of affect recognition | The social cognitive marker will be evaluate by NeuroPsychologic assessment NEPSY II for theory of affect recognition | Change from baseline 6 month later | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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emotional, auditory hallucinations, non-psychotic children