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Completed

NCT Number: NCT01545505

Identification of Markers of Post-Traumatic Stress Disorder (PTSD) Relapse

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.

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Key information

Age range

9 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de NICE, Nice, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neuropsychological Assessment

Behavioral

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.

Primary outcomes

  1. Attentional score

    Time frame: baseline at the first visit (T0), at 6 months, at 9 months

    Go-No/Go and visual search tests

Secondary outcomes

  1. memory (Grober and Buschke)

    Time frame: baseline at the first visit (T0), at 6 months, at 9 months

    Grober and Buschke memory tests

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

Early Diagnosis of Risk of Post-Traumatic Stress Disorder (PTSD) Relapse in Children and Their Families

Important dates

Study start
2012
Primary completion
2013
Study completion
2016
First posted
Mar 6, 2012
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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