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Trial record 13 of 1495 for:    child psychiatry

Prevalence of Dissociative Disorders in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01512641
Recruitment Status : Completed
First Posted : January 19, 2012
Last Update Posted : February 3, 2014
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Tracking Information
First Submitted Date  ICMJE December 13, 2011
First Posted Date  ICMJE January 19, 2012
Last Update Posted Date February 3, 2014
Study Start Date  ICMJE December 2011
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 18, 2012)
Rate of children diagnosed with dissociative disorders [ Time Frame: between 2 and 4 hours depending children ]
Rate of children diagnosed with dissociative disorders: children positive for the test Kiddie-Schedule for Affective Disorders and Schizophrenia (Kiddie-SADS).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01512641 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 18, 2012)
  • Percentage of children positive for test: Autism Diagnostic Interview-Revise (ADI-R). [ Time Frame: 1 day on average ]
  • Scores of three dimensions of schizophrenia in the Positive And Negative Syndrome Scale (PANSS) [ Time Frame: 4 hours ]
    3 dimensions: positive symptoms, negative symptoms and general psychopathology, based on these scores the diagnostic subtype of schizophrenia is established.
  • Score at the Test Lillois de Communication (TLC) [ Time Frame: 30 minutes ]
  • Score on the Wechsler Intelligence Scale for Children-Fourth Edition (WISC IV)subtests and overall intelligence quotient (IQ). [ Time Frame: 4 hours ]
  • Response time to test verbal fluency, scores on the Trail Making Test A (TMT) and TMT B. [ Time Frame: 30 minutes ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prevalence of Dissociative Disorders in Children
Official Title  ICMJE Prevalence of Dissociative Disorders in Children in a Population Supported in the Medico-social and Health Structures in Provence Alpes Cote d'Azur
Brief Summary

Schizophrenia beginning before 18 years is a clinical entity not well known because of its low incidence and difficulties in the clinical diagnosis.

However, in the investigators clinical practice, due to the specialization of the investigators service, the investigators are led to hospital to receive important feel active of patients meeting the Diagnostic and Statistical Manual of Mental Disorders IV text revision (DSM IV-TR) precose schizophrenia.

The work of us team on the theme of the relationship between Pervasive Developmental Disorders and precose Schizophrenia led us to hypothesize that a number of children in care in the medical and educational institutes, hospitals and day shelters therapeutic part-time symptoms of schizophrenia or a line real early diagnosis of schizophrenia undervalued or not diagnosed.

The main goal is to estimate the prevalence of dissociative disorders in a population of children in care institutions and medical education in child psychiatry in hospitals and others structures.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Dissociative Disorders
  • Schizophrenia
Intervention  ICMJE
  • Other: Primary stage
    Kiddie-Schedule for Affective Disorders and Schizophrenia
  • Other: Secondary stage
    children who are positive to the kiddie-SADS (primary stage), will take the tests: PANSS, Scale for the Assessment of Negative Symptoms (SANS), ADI-R, scale TLC and WISC IV
Study Arms  ICMJE Experimental: Children with Dissociative Disorders
Children will take first the primary stage. If one child is positive, he will pass the secondary stage.
Interventions:
  • Other: Primary stage
  • Other: Secondary stage
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 31, 2014)
301
Original Estimated Enrollment  ICMJE
 (submitted: January 18, 2012)
3360
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 7 to 18 years
  • Supported in the partner institutions of the study
  • IQ>35 on the certificate of orientation of the Maison Départementale des Personnes Handicapées (MDPH)
  • Obtaining the agreement of parents and children

Exclusion Criteria:

  • QI<35 on the certificate file Guidance MDPH
  • Children not speaking french
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01512641
Other Study ID Numbers  ICMJE 11-API-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre Hospitalier Universitaire de Nice
Study Sponsor  ICMJE Centre Hospitalier Universitaire de Nice
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Florence ASKENAZY, PU-PH University hospital of Nice
Principal Investigator: Emmanuelle DOR, PH University hospital of Nice
Principal Investigator: François POINSO, PU-PH AP-HM
Principal Investigator: Michèle BATTISTA, PH Frejus's hospital
Principal Investigator: Michel BOUBLIL, PH Antibes's hospital
PRS Account Centre Hospitalier Universitaire de Nice
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP