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 |
|---|---|---|---|---|---|---|---|---|
| Experimental Group | It combines social cognitive and executive functions skills and it will be present on the designed website and they will participate in the intervention online. After participants are assigned the experimental group the 6-week training program will start and they cannot access the next week before completing the previous week. Each week's will last about 75 minutes. The training includes social cognitive skills including cognitive and affective empathy and executive functions. MindZone: The name of the online training will be MindZone. It consists of combined game-based social cognitive and executive functions skills, and it will be presented on the training website. There is no consensus about the length of time for the training in the literature, so the average time for the training process will be used. This means that the training will last 6 weeks, 5 hours in total. To satisfy the training requirement, 50 mins for each week of play will be expected from participants each week. Before each game, a brief introduction about the game will be presented and participants will get feedback about their progress. Each participant will conduct the tasks in a different random order. After 6 weeks, a post-test will be completed, and follow-up scores will be obtained after a month. All tasks were designed according to the five intervention areas: working memory, cognitive flexibility, inhibition, cognitive empathy and affective empathy based on the literature. | 0 | None | 0 | 0 | 0 | 0 | View |
| Control Group | This group will not take the training until the follow-up test. After the study will be done, the training program will be offered to the control group as well. | 0 | None | 0 | 0 | 0 | 0 | View |