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The Physalis Child : Identification of Cognitive and Emotional Factors

Primary Purpose

Auditory Hallucinations

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Patients with auditory hallucination
Patients without auditory hallucination
Sponsored by
Fondation Lenval
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Auditory Hallucinations focused on measuring emotional, auditory hallucinations, non-psychotic children

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fondation Lenval

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Patients with auditory hallucination

Patients without auditory hallucination

Arm Description

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

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 )

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Evolution of the score of auditory hallucinations persistence
Evaluation of auditory hallucinations persistence with a self report scale using in recruiting criteria.
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 )
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)
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
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)
Evolution of auditory measure of patients' emotional
The auditory measure will be performed by the score: The social cognitive marker (NEPSY II)
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)
Evolution of the score of affect recognition
The social cognitive marker will be evaluate by NeuroPsychologic assessment NEPSY II for theory of affect recognition

Full Information

First Posted
July 24, 2015
Last Updated
July 27, 2018
Sponsor
Fondation Lenval
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1. Study Identification

Unique Protocol Identification Number
NCT02567500
Brief Title
The Physalis Child : Identification of Cognitive and Emotional Factors
Official Title
Identification of Cognitive and Emotional Factors in Relation to Auditory Hallucinations in Non-psychotic Children
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
July 7, 2015 (Actual)
Primary Completion Date
July 7, 2017 (Actual)
Study Completion Date
July 7, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Lenval

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Auditory Hallucinations
Keywords
emotional, auditory hallucinations, non-psychotic children

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with auditory hallucination
Arm Type
Experimental
Arm Description
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
Arm Title
Patients without auditory hallucination
Arm Type
Placebo Comparator
Arm Description
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 )
Intervention Type
Behavioral
Intervention Name(s)
Patients with auditory hallucination
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Patients without auditory hallucination
Intervention Description
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
Primary Outcome Measure Information:
Title
Evolution of the score of theory of mind
Description
The social cognitive marker will be evaluate by NeuroPsychologic assessment NEPSY II for theory of mind
Time Frame
Change from baseline 6 month later
Secondary Outcome Measure Information:
Title
Evolution of the score of auditory hallucinations persistence
Description
Evaluation of auditory hallucinations persistence with a self report scale using in recruiting criteria.
Time Frame
Change from baseline 6 month later
Title
Evolution of the score of Mental Disorder
Description
Evaluation of diagnosis of Mental Disorder with Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV criteria using MINI-Kids (Mini International Neuropsychiatric Interview )
Time Frame
Change from baseline 6 month later
Title
Evaluation of the score of Psychosis
Description
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)
Time Frame
Change from baseline 6 month later
Title
Evolution of the score of individual stability
Description
The evaluation of the the emotional marker will be performed with the Differential emotion scale IV (DES IV): emotional individual stability
Time Frame
Change from baseline 6 month later
Title
Evolution of measure of recognition of the feelings
Description
The measure of recognition of the feelings will be performed by the score: The social cognitive marker (NEPSY II)
Time Frame
Change from baseline 6 month later
Title
Evolution of auditory measure of patients' emotional
Description
The auditory measure will be performed by the score: The social cognitive marker (NEPSY II)
Time Frame
Change from baseline 6 month later
Title
Evolution of Emotional real-life experience of the hallucination
Description
The Emotional real-life experience of the hallucination will be performed by the score: The Revised Beliefs About Voices Questionnaire (BAVQ-R)
Time Frame
Change from baseline 6 month later
Title
Evolution of the score of affect recognition
Description
The social cognitive marker will be evaluate by NeuroPsychologic assessment NEPSY II for theory of affect recognition
Time Frame
Change from baseline 6 month later

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valérie BONNARD-COUTON, MD
Organizational Affiliation
Fondation Lenval
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondation Lenval
City
Nice
ZIP/Postal Code
06200
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
34625214
Citation
Dumas LE, Bonnard-Couton V, Golse B, Askenazy F. [Identifying cognitive and emotional markers in relation to auditory-verbal hallucinations in pediatric population: Physalis study]. Encephale. 2022 Oct;48(5):546-554. doi: 10.1016/j.encep.2021.06.010. Epub 2021 Oct 5. French.
Results Reference
derived

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The Physalis Child : Identification of Cognitive and Emotional Factors

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