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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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01545505
Enrollment
6
Registered
2012-03-06
Start date
2012-10-01
Completion date
2016-12-30
Last updated
2026-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Traumatic Stress Disorder (PTSD)

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.

Interventions

BEHAVIORALNeuropsychological 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.

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Eligibility

Sex/Gender
ALL
Age
9 Years to 18 Years
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Attentional scorebaseline at the first visit (T0), at 6 months, at 9 monthsGo-No/Go and visual search tests

Secondary

MeasureTime frameDescription
memory (Grober and Buschke)baseline at the first visit (T0), at 6 months, at 9 monthsGrober and Buschke memory tests

Countries

France

Contacts

PRINCIPAL_INVESTIGATORMichel BENOIT, M.D.,PhD

Psychiatrie, Hôpital Pasteur, CHU de NICE

PRINCIPAL_INVESTIGATORWissam EL HAGE, M.D, PhD

Psychiatrie, CHU de TOURS

PRINCIPAL_INVESTIGATORFrédérique JOVER, M.D.

CAP, Hôpital St ROCH, CHU de NICE

PRINCIPAL_INVESTIGATORFlorence ASKENAZY, M.D.

Fondation Lenval, NICE

PRINCIPAL_INVESTIGATORPhilippe BIRMES, M.D.

Psychiatrie, CHU de TOULOUSE

PRINCIPAL_INVESTIGATORVirginie BUISSE, M.D.

CAP, Hôpital St Roch, CHU de NICE

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 18, 2026