The Physalis Child : Identification of Cognitive and Emotional Factors

Auditory Hallucinations Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02567500
• Other study ID #: 14-HPNCL-02
• Status: Completed
• Phase: N/A
• Start date: July 7, 2015
• Est. completion date: July 7, 2017

Study information

• Verified date: July 2018
• Source: Fondation Lenval
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 7, 2017
• Est. primary completion date: July 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Auditory Hallucinations
• Hallucinations

Intervention

Behavioral:
• Patients with auditory hallucination
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
• Patients without auditory hallucination
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

Locations

Country	Name	City	State
France	Fondation Lenval	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Lenval

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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