The Physalis Child : Identification of Cognitive and Emotional Factors

July 27, 2018 updated by: Fondation Lenval

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nice, France, 06200
        • Fondation Lenval

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Behavioral: 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
Placebo Comparator: 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 )
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from baseline 6 month later

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline 6 month later
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 )
Change from baseline 6 month later
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)
Change from baseline 6 month later
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
Change from baseline 6 month later
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)
Change from baseline 6 month later
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)
Change from baseline 6 month later
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)
Change from baseline 6 month later
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
Change from baseline 6 month later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Lenval

Investigators

  • Principal Investigator: Valérie BONNARD-COUTON, MD, Fondation Lenval

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 7, 2015

Primary Completion (Actual)

July 7, 2017

Study Completion (Actual)

July 7, 2017

Study Registration Dates

First Submitted

July 24, 2015

First Submitted That Met QC Criteria

October 2, 2015

First Posted (Estimate)

October 5, 2015

Study Record Updates

Last Update Posted (Actual)

July 30, 2018

Last Update Submitted That Met QC Criteria

July 27, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-HPNCL-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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