- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01545505
Identification of Markers of Post-Traumatic Stress Disorder (PTSD) Relapse
Early Diagnosis of Risk of Post-Traumatic Stress Disorder (PTSD) Relapse in Children and Their Families
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
One of the great challenges in Psychotraumatology is the high risk (20-40%) of post-traumatic stress disorder (PTSD) relapse, which markers remain understudied. Identification of these markers is of particular interest for the development of strategies to prevent relapse. Based on clinical and experimental data, it appears that (i) the so-called residual clinical symptoms (such as sleep disturbance, irritability) and (ii) the neuropsychological dysfunctions (cognitive difficulties), persisting after remission, may constitute markers of PTSD relapse. Moreover, all of these potential markers have also been linked with dysfunctions, persisting or reoccurring, in the prefrontal cortex after remission.
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Nice, France, 06000
- CHU de Nice
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Nice, France, 06000
- Fondation Lenval
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Toulouse, France, 31059
- CHU de Toulouse
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Tours, France, 37044
- Chu De Tours
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
For children
Inclusion Criteria:
- Children (9/18 years)
- 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 a neurological pathology.
- Children who have brain damage or brain-injured
- Subject having participated in a biomedical research in three months preceding the inclusion
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: In remission phase of PTSD
Patients having suffered from PTSD in the past and in remission od PTSD and their parents
|
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. |
|
Other: Activ PTSD
patients suffering from PTSD (Post-traumatic Stress Disorder) and their parents
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Attentional score
Time Frame: baseline at the first visit (T0), at 6 months, at 9 months
|
Go-No/Go and visual search tests
|
baseline at the first visit (T0), at 6 months, at 9 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
memory (Grober and Buschke)
Time Frame: baseline at the first visit (T0), at 6 months, at 9 months
|
Grober and Buschke memory tests
|
baseline at the first visit (T0), at 6 months, at 9 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Michel BENOIT, M.D.,PhD, Psychiatrie, Hôpital Pasteur, CHU de NICE
- Principal Investigator: Wissam EL HAGE, M.D, PhD, Psychiatrie, CHU de TOURS
- Principal Investigator: Frédérique JOVER, M.D., CAP, Hôpital St Roch, CHU de NICE
- Principal Investigator: Florence ASKENAZY, M.D., Fondation Lenval, NICE
- Principal Investigator: Philippe BIRMES, M.D., Psychiatrie, CHU de TOULOUSE
- Principal Investigator: Virginie BUISSE, M.D., CAP, Hôpital St Roch, CHU de NICE
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11-AOI-09
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