Questionnaire for the Evaluation of Anger, Hostility and Aggression After Acquired Brain Injury.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04034875|
Recruitment Status : Recruiting
First Posted : July 26, 2019
Last Update Posted : July 26, 2019
The incidence of aggression and violent behavior is usually reported to be high after acquired brain injury, around 54%. Behaviors with verbal agression and, less frequently, physical agressions, are described.
These behaviors may be linked to the dysfunction of the frontal lobes responsible for executive functions and complex social interactions, or to the dysfunction of the temporal structures that may also be responsible for increased aggression.
It is interesting to note that very few scales or specific questionnaires evaluate the factors and co-variables that could lead to aggressive behavior after an acquired brain injury. Such questionnaires are very rare, and none have been validated in French.
The objective of this study is to develop a questionnaire in French that aims to assess anger, hostility and aggression after acquired brain injury. The psychometric qualities of this questionnaire will be evaluated using the Rasch probabilistic model.
The development of such a tool will be of major interest for clinical practice and future clinical research.
|Condition or disease||Intervention/treatment||Phase|
|Cerebral Lesion||Other: Questionnaire||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||SOCIALBI, a Rasch Questionnaire for the Evaluation of Anger, Hostility and Aggression After Acquired Brain Injury.|
|Actual Study Start Date :||April 9, 2019|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
|Experimental: Patients with acquired brain injury||
- Questionnaire evaluation by Rasch methodology [ Time Frame: 30 minutes ]questionnaire validity
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04034875
|Contact: Eric Durand, MD||3224758121||Eric.DURAND@chu-brugmann.be|
|Brugmann University Hospital||Recruiting|
|Brussels, Belgium, 1020|
|Contact: Eric Durand, MD Eric.DURAND@chu-brugmann.be|
|Principal Investigator: Eric Durand, MD|
|Hôpital Universitaire Pitié-Salpêtrière||Not yet recruiting|
|Contact: Pradat-Diehl, Pr|
|Hôpitaux Saint Maurice||Not yet recruiting|
|Contact: Chevignard, MD PhD|
|Principal Investigator:||Eric Durand, MD||CHU Brugmann|