Auditory HallucinationsNCT02567500
The Physalis Child : Identification of Cognitive and Emotional Factors
A study testing Patients with auditory hallucination and Patients without auditory hallucination in people with Auditory Hallucinations, run by Fondation Lenval at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Auditory Hallucinations
- What is being tested?
- Patients with auditory hallucination and Patients without auditory hallucination
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jul 2015to 7 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Show all 12Show fewer
- 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.
Who cannot join
- schizophrenia diagnosis,
- neurologic, genetic or neurosensory disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Patients with auditory hallucination, Patients without auditory hallucination
- Keywords
- emotional, auditory hallucinations, non-psychotic children
- Medical subject headings
- Hallucinations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients with auditory hallucinationBehavioural
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 hallucinationBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 ) Receives: Behavioral: Patients without auditory hallucination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of the score of theory of mind
The social cognitive marker will be evaluate by NeuroPsychologic assessment NEPSY II for theory of mind
Measured: Change from baseline 6 month later
Secondary outcomes (8)
Evolution of the score of auditory hallucinations persistence
Evaluation of auditory hallucinations persistence with a self report scale using in recruiting criteria.
Measured: Change from baseline 6 month later
Evolution of the score of Mental Disorder
Evaluation of diagnosis of Mental Disorder with Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV criteria using MINI-Kids (Mini International Neuropsychiatric Interview )
Measured: Change from baseline 6 month later
Evaluation of the score of Psychosis
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)
Measured: Change from baseline 6 month later
Evolution of the score of individual stability
The evaluation of the the emotional marker will be performed with the Differential emotion scale IV (DES IV): emotional individual stability
Measured: Change from baseline 6 month later
Evolution of measure of recognition of the feelings
The measure of recognition of the feelings will be performed by the score:
The social cognitive marker (NEPSY II)
Measured: Change from baseline 6 month later
Evolution of auditory measure of patients' emotional
The auditory measure will be performed by the score:
The social cognitive marker (NEPSY II)
Measured: Change from baseline 6 month later
Evolution of Emotional real-life experience of the hallucination
The Emotional real-life experience of the hallucination will be performed by the score:
The Revised Beliefs About Voices Questionnaire (BAVQ-R)
Measured: Change from baseline 6 month later
Evolution of the score of affect recognition
The social cognitive marker will be evaluate by NeuroPsychologic assessment NEPSY II for theory of affect recognition
Measured: Change from baseline 6 month later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2015 (estimated)
- Study start7 Jul 2015
- Primary completion7 Jul 2017
- Study completion7 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Auditory HallucinationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Lenval
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valérie BONNARD-COUTON, MD, Principal investigator, Fondation Lenval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02567500
- Sponsor's protocol ID
- 14-HPNCL-02
- Status last verified
- Jul 2018
- First submitted
- 24 Jul 2015
- Last updated
- 30 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34625214
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Cognitive and Emotional Factors in Relation to Auditory Hallucinations in Non-psychotic Children
- ClinicalTrials.gov ID
- NCT02567500
- Acronym / sponsor ID
- 14-HPNCL-02
- Conditions
- Auditory Hallucinations
- Keywords
- emotional, auditory hallucinations, non-psychotic children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Fondation LenvalUniversity, hospital or other
- Study start
- 7 Jul 2015 (actual)
- Primary completion
- 7 Jul 2017 (actual)
- Study completion
- 7 Jul 2017 (actual)
- First posted
- 5 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with auditory hallucination | Experimental | Behavioral: Patients with auditory hallucinationPatients 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 |
| Patients without auditory hallucination | Placebo comparator | Behavioral: Patients without auditory hallucinationPatients 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 ) |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- Twenty participants included with auditory hallucination:
- Twenty participants included without auditory hallucination:
Key exclusion criteria (2 listed)
- schizophrenia diagnosis,
- neurologic, genetic or neurosensory disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients with auditory hallucinationPatients 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 | Behavioural | Patients with auditory hallucination |
| Patients without auditory hallucinationPatients 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 | Behavioural | Patients without auditory hallucination |
Primary outcome
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
8 secondary outcomes
Evolution of the score of auditory hallucinations persistence
Time frame: Change from baseline 6 month later
Evolution of the score of Mental Disorder
Time frame: Change from baseline 6 month later
Evaluation of the score of Psychosis
Time frame: Change from baseline 6 month later
Evolution of the score of individual stability
Time frame: Change from baseline 6 month later
Evolution of measure of recognition of the feelings
Time frame: Change from baseline 6 month later
Evolution of auditory measure of patients' emotional
Time frame: Change from baseline 6 month later
Evolution of Emotional real-life experience of the hallucination
Time frame: Change from baseline 6 month later
Evolution of the score of affect recognition
Time frame: Change from baseline 6 month later
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2018.
- Derived from this study: PubMed 34625214Dumas 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.
Related trials for Auditory Hallucinations
Recruiting
Theta-Burst Transcranial Magnetic Stimulation for Treatment-Resistant Auditory Hallucinations
Auditory Verbal Hallucinations, Schizophrenia
Not yet recruiting
DecNef for Auditory Verbal Hallucinations (AVH) in Schizophrenia
Schizophrenia Disorder, Schizoaffecitve Disorder
Recruiting
Neuronavigated rTMS for Treatment-Resistant Auditory Hallucinations
Schizophrenia, Auditory Verbal Hallucinations
Recruiting
fMRI-based Neurofeedback to Relieve Drug-resistant Auditory Hallucinations
Schizophrenia, Hallucinations, Auditory
Recruiting
Reduction of Auditory-Verbal Hallucinations in Schizophrenia Through Cortical Neuromodulation
Treatment Resistant Schizophrenia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valérie BONNARD-COUTON, MD principal investigator
Fondation Lenval
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patients with auditory hallucination and Patients without auditory hallucination in people with Auditory Hallucinations, run by Fondation Lenval at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of the score of theory of mind (time frame: Change from baseline 6 month later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02567500, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2018.