Clinical trial NCT02567500: 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
Overall status: COMPLETED
Phase: NA
Conditions: Auditory Hallucinations
Keywords: emotional
auditory hallucinations
non-psychotic children
Lead sponsor: Fondation Lenval
Sponsor class: OTHER
First posted: 2015-10-05
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Evolution of the score of theory of mind
timeFrame: Change from baseline 6 month later
Secondary outcomes:
measure: Evolution of the score of auditory hallucinations persistence
timeFrame: Change from baseline 6 month later
measure: Evolution of the score of Mental Disorder
timeFrame: Change from baseline 6 month later
measure: Evaluation of the score of Psychosis
timeFrame: Change from baseline 6 month later
measure: Evolution of the score of individual stability
timeFrame: Change from baseline 6 month later
measure: Evolution of measure of recognition of the feelings
timeFrame: Change from baseline 6 month later
measure: Evolution of auditory measure of patients' emotional
timeFrame: Change from baseline 6 month later
measure: Evolution of Emotional real-life experience of the hallucination
timeFrame: Change from baseline 6 month later
measure: Evolution of the score of affect recognition
timeFrame: Change from baseline 6 month later
Other outcomes:
Locations:
city: Nice
country: France
facility: Fondation Lenval
Study officials:
affiliation: Fondation Lenval
name: Valérie BONNARD-COUTON, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.