Clinical trial NCT01545505: Identification of Markers of Post-Traumatic Stress Disorder (PTSD) Relapse
Official title: Early Diagnosis of Risk of Post-Traumatic Stress Disorder (PTSD) Relapse in Children and Their Families
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post Traumatic Stress Disorder (PTSD)
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2012-03-06
Enrollment: 120
Sex: ALL
Minimum age (years): 9
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Relapse of post-traumatic stress disorder (PTSD) remains challenging. In addition, factors predicting PTSD relapse are still unknown. The aim of this study is to examine whether clinical and neuropsychological changes (e.g., attentional bias toward aversive cues) that characterized PTSD can be observed in people with past PTSD (children and their families) and whether these persistent changes are predictive of PTSD relapse.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Attentional score
timeFrame: baseline at the first visit (T0), at 6 months, at 9 months
Secondary outcomes:
measure: memory (Grober and Buschke)
timeFrame: baseline at the first visit (T0), at 6 months, at 9 months
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de NICE
city: Nice
country: France
facility: Fondation Lenval
city: Toulouse
country: France
facility: CHU de TOULOUSE
city: Tours
country: France
facility: CHU de TOURS
Study officials:
affiliation: Psychiatrie, Hôpital Pasteur, CHU de NICE
name: Michel BENOIT, M.D.,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Psychiatrie, CHU de TOURS
name: Wissam EL HAGE, M.D, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: CAP, Hôpital St ROCH, CHU de NICE
name: Frédérique JOVER, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Fondation Lenval, NICE
name: Florence ASKENAZY, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Psychiatrie, CHU de TOULOUSE
name: Philippe BIRMES, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: CAP, Hôpital St Roch, CHU de NICE
name: Virginie BUISSE, M.D.
role: PRINCIPAL_INVESTIGATOR
References: