The Physalis Child : Identification of Cognitive and Emotional Factors

NCT02567500 | Completed

• 1 other identifier: 14-HPNCL-02
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Auditory Hallucinations

Keywords

emotional; auditory hallucinations; non-psychotic children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Evolution of the score of auditory hallucinations persistence

  Change from baseline 6 month later

• Evolution of the score of Mental Disorder

  Change from baseline 6 month later

• Evaluation of the score of Psychosis

  Change from baseline 6 month later

• Evolution of the score of individual stability

  Change from baseline 6 month later

• Evolution of measure of recognition of the feelings

  Change from baseline 6 month later

Study Arms (2)

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

Behavioral: Patients with auditory hallucination

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 )

Behavioral: Patients without auditory hallucination

Interventions

Patients with auditory hallucination 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 with auditory hallucination

Patients without auditory hallucination 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

Patients without auditory hallucination

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• schizophrenia diagnosis,
• neurologic, genetic or neurosensory disorders

Sponsors & Collaborators

• Fondation Lenval: lead

Study Sites (1)

Fondation Lenval

Nice, 06200, France

Location

Related Publications (1)

• 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.

  PMID: 34625214 DERIVED

MeSH Terms

Conditions

Hallucinations

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Valérie BONNARD-COUTON, MD

  Fondation Lenval

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2015
• First Posted: October 5, 2015
• Study Start: July 7, 2015
• Primary Completion: July 7, 2017
• Study Completion: July 7, 2017
• Last Updated: July 30, 2018

Record last verified: 2018-07

Locations

FR (1)