Questionnaire for the Evaluation of Anger, Hostility and Aggression After Acquired Brain Injury.
SOCIALBI, a Rasch Questionnaire for the Evaluation of Anger, Hostility and Aggression After Acquired Brain Injury.
1 other identifier
interventional
50
2 countries
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2019
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 9, 2019
CompletedFirst Submitted
Initial submission to the registry
July 23, 2019
CompletedFirst Posted
Study publicly available on registry
July 26, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 28, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 28, 2023
CompletedMay 9, 2024
May 1, 2024
4.3 years
July 23, 2019
May 7, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Questionnaire evaluation by Rasch methodology
questionnaire validity
30 minutes
Study Arms (1)
Patients with acquired brain injury
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Patients of the CHU Brugmann Hospital
- Central neurological pathology of vascular or traumatic origin, acute or chronic (known since more than one year).
You may not qualify if:
- Pregnant or lactating women
- Presence or antecedents of psychiatric disease
- Degenerative pathology (ex: Parkinson...)
- Antecedents of other neurologic pathologies before the acquired lesion
- Oral or written comprehension dysfunctions.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Brugmann University Hospital
Brussels, 1020, Belgium
Hôpital Universitaire Pitié-Salpêtrière
Paris, France
Hôpitaux Saint Maurice
Saint-Maurice, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Durand, MD
CHU Brugmann
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of clinical trial unit
Study Record Dates
First Submitted
July 23, 2019
First Posted
July 26, 2019
Study Start
April 9, 2019
Primary Completion
July 28, 2023
Study Completion
July 28, 2023
Last Updated
May 9, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share