Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Phase IIA - In-person | Participants will be assigned to either (a) a virtual reality-based intervention or (b) a video modeling intervention, both aimed at improving police interaction skills. Assessments of police interaction skills will occur in-person before/after intervention (three sessions of each, separated by approximately 1 week). Virtual Reality Intervention: Floreo's Police Safety Module (PSM) is a 3D immersive story-based intervention designed to engage the user in a virtual encounter with a law enforcement officer. The immersive VR environment engages the person as an actor in a virtual narrative, incorporating strategies from both story-based intervention and video modeling to practice social skills. The video demonstrates the approach and initial engagement efforts of two police officers in the virtual environment, from the perspective of the person wearing the headset. The PSM allows a monitoring therapist to use a tablet or phone to supervise the person's virtual world. Video Modeling Intervention: The video modeling intervention is a subset of the BE SAFE The Movie Curriculum Lessons (https://besafethemovie.com/curriculum/) that were selected to match Floreo PSM on length. The BE SAFE The Movie Curriculum consists of video-based instruction on police officer interaction expectations and safety. Within each of three sessions, participants will watch videos, complete worksheets, and discuss topics related to police safety knowledge and behaviors with the study administrator. | 0 | None | 0 | 47 | 0 | 47 | View |
| Phase IIB - Remote | Participants will be assigned to either (a) three sessions of remote at-home virtual reality-based intervention aimed at improving police interaction skills or (b) no intervention (treatment-as-usual, TAU). Remote videoconference-based assessments of police skills will occur before intervention, after intervention, and 3-4 weeks follow-up in the intervention group and at comparable timepoints in the no intervention group. Virtual Reality Intervention: Floreo's Police Safety Module (PSM) is a 3D immersive story-based intervention designed to engage the user in a virtual encounter with a law enforcement officer. The immersive VR environment engages the person as an actor in a virtual narrative, incorporating strategies from both story-based intervention and video modeling to practice social skills. The video demonstrates the approach and initial engagement efforts of two police officers in the virtual environment, from the perspective of the person wearing the headset. The PSM allows a monitoring therapist to use a tablet or phone to supervise the person's virtual world via videoconference. No intervention: Participants will follow all study procedures with the exception of the VR-based intervention including assessments. | 0 | None | 0 | 50 | 0 | 50 | View |