Identification of Markers of Post-Traumatic Stress Disorder (PTSD) Relapse
NCT ID: NCT01545505
Last Updated: 2013-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2012-10-31
2014-07-31
Brief Summary
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Detailed Description
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The main objective of this study is to identify these clinical and neuropsychological markers of PTSD relapse in children and their families. The secondary objective is to demonstrate the link between prefrontal dysfunctions and relapse.
This longitudinal study will include 4 experimental groups:
* 30 children with PTSD
* 30 children with past PTSD (children in remission)
* 30 parents of children with PTSD
* 30 parents of children with past PTSD The first visit is planned during the symptomatic phase (T0). The second visit (T1) is planned at the end of the symptomatic phase (or 6 months later T0). The last visit is planned 3-months after T1.
The psychological assessment will include:
A structured interview with a psychiatrist An assessment of PTSD symptoms (IES-R, CPTS-RI for children) An assessment of the co-morbidity (STAI C and CDI for children, STAI A-B, BDI for adults).
An evaluation of the social life (EAS for children and SAS-SR for adults).
The neuropsychological assessment will include:
An evaluation of the attentional treatment (Go-No / go and visual search) An evaluation of executive functions (TMT A and B) A brief evaluation of the IQ (items memory of figures, matrix and resemblance) An evaluation of the memory (Grober and Buschke) Tests include an adult and children versions that are validated. All studies will be conducted at the Nice University Hospital, Tours University Hospital and Toulouse University Hospital.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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In remission phase of PTSD
Patients having suffered from PTSD in the past and in remission od PTSD and their parents
Neuropsychological assessment
A clinical evaluation with Impact of Events Scale-Revised, Child Post-Traumatic Stress Reaction Index, State-Trait Anxiety Inventory for Children, Children Depression Inventory and Emotion, activity and sociability.
A neuropsychological assessment with a emotional Go-No/Go, a visual search task, the Trail Making Test, 3 items of the WISC III ( and the Grober and Buschke Test.
Activ PTSD
patients suffering from PTSD (Post-traumatic Stress Disorder) and their parents
Neuropsychological assessment
A clinical evaluation with Impact of Events Scale-Revised, Child Post-Traumatic Stress Reaction Index, State-Trait Anxiety Inventory for Children, Children Depression Inventory and Emotion, activity and sociability.
A neuropsychological assessment with a emotional Go-No/Go, a visual search task, the Trail Making Test, 3 items of the WISC III ( and the Grober and Buschke Test.
Interventions
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Neuropsychological assessment
A clinical evaluation with Impact of Events Scale-Revised, Child Post-Traumatic Stress Reaction Index, State-Trait Anxiety Inventory for Children, Children Depression Inventory and Emotion, activity and sociability.
A neuropsychological assessment with a emotional Go-No/Go, a visual search task, the Trail Making Test, 3 items of the WISC III ( and the Grober and Buschke Test.
Eligibility Criteria
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Inclusion Criteria
* Patients who have lived a traumatic event (physical assault and road accident) and who have a PTSD.
* French speaker.
* Participants must sign the informed consent and they must be affiliated to the social insurance.
Exclusion Criteria
* Children who have brain damage or brain-injured
* Subject having participated in a biomedical research in three months preceding the inclusion
9 Years
18 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Nice
OTHER
Responsible Party
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Principal Investigators
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Michel BENOIT, M.D.,PhD
Role: PRINCIPAL_INVESTIGATOR
Psychiatrie, Hôpital Pasteur, CHU de NICE
Wissam EL HAGE, M.D, PhD
Role: PRINCIPAL_INVESTIGATOR
Psychiatrie, CHU de TOURS
Frédérique JOVER, M.D.
Role: PRINCIPAL_INVESTIGATOR
CAP, Hôpital St ROCH, CHU de NICE
Florence ASKENAZY, M.D.
Role: PRINCIPAL_INVESTIGATOR
Fondation Lenval, NICE
Philippe BIRMES, M.D.
Role: PRINCIPAL_INVESTIGATOR
Psychiatrie, CHU de TOULOUSE
Virginie BUISSE, M.D.
Role: PRINCIPAL_INVESTIGATOR
CAP, Hôpital St Roch, CHU de NICE
Locations
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CHU de NICE
Nice, , France
Fondation Lenval
Nice, , France
CHU de TOULOUSE
Toulouse, , France
CHU de TOURS
Tours, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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11-AOI-09
Identifier Type: -
Identifier Source: org_study_id
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