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Completed

NCT Number: NCT02567500

The Physalis Child : Identification of Cognitive and Emotional Factors

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.

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Key information

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondation Lenval

Nice, 06200, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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

Primary outcomes

  1. Evolution of the score of theory of mind

    Time frame: Change from baseline 6 month later

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

Secondary outcomes

  1. Evolution of the score of auditory hallucinations persistence

    Time frame: Change from baseline 6 month later

    Evaluation of auditory hallucinations persistence with a self report scale using in recruiting criteria.

  2. Evolution of the score of Mental Disorder

    Time frame: Change from baseline 6 month later

    Evaluation of diagnosis of Mental Disorder with Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV criteria using MINI-Kids (Mini International Neuropsychiatric Interview )

  3. Evaluation of the score of Psychosis

    Time frame: Change from baseline 6 month later

    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)

  4. Evolution of the score of individual stability

    Time frame: Change from baseline 6 month later

    The evaluation of the the emotional marker will be performed with the Differential emotion scale IV (DES IV): emotional individual stability

  5. Evolution of measure of recognition of the feelings

    Time frame: Change from baseline 6 month later

    The measure of recognition of the feelings will be performed by the score:

    The social cognitive marker (NEPSY II)

  6. Evolution of auditory measure of patients' emotional

    Time frame: Change from baseline 6 month later

    The auditory measure will be performed by the score:

    The social cognitive marker (NEPSY II)

  7. Evolution of Emotional real-life experience of the hallucination

    Time frame: Change from baseline 6 month later

    The Emotional real-life experience of the hallucination will be performed by the score:

    The Revised Beliefs About Voices Questionnaire (BAVQ-R)

  8. Evolution of the score of affect recognition

    Time frame: Change from baseline 6 month later

    The social cognitive marker will be evaluate by NeuroPsychologic assessment NEPSY II for theory of affect recognition

Sponsors and collaborators

Lead sponsor

Fondation Lenval

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 5, 2015
Registry last updated
Jul 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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