The Physalis Child : Identification of Cognitive and Emotional Factors

NCT ID: NCT02567500

Last Updated: 2018-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-07
• Study Completion Date: 2017-07-07

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.

Conditions

Auditory Hallucinations

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patients with auditory hallucination

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

Group Type: EXPERIMENTAL

Patients with auditory hallucination

Intervention Type: BEHAVIORAL

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:

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 )

Group Type: PLACEBO_COMPARATOR

Patients without auditory hallucination

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondation Lenval

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Valérie BONNARD-COUTON, MD

Role: PRINCIPAL_INVESTIGATOR

Fondation Lenval

Locations

Fondation Lenval

Nice, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 34625214 (View on PubMed)

Other Identifiers

14-HPNCL-02

Identifier Type: -

Identifier Source: org_study_id