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 |
|---|---|---|---|---|---|---|---|---|
| Biofeedback Enhanced Treatment | Participants will engage in biofeedback-enhanced, cognitive-behavioral coping skills treatment. Sessions will include brief, daily homework assignments tailored to youth (e.g., using apps for skill practice). Participants will complete pre- and post-session questionnaires to assess autonomic reactivity, lifetime stress, depression, anxiety, and coping strategies in response to stress induction. Biofeedback Enhanced Treatment: The intervention involves biofeedback enhanced cognitive behaviorally based coping skills treatment. Treatment will consist of a 6-visit group intervention conducted online, via Emory Zoom. Groups will include 5-8 patients each. Sessions will include brief, daily homework to facilitate mastery, developmentally tailored to youth (e.g., practice skills with support from phone or tablet apps). Groups will meet approximately every week for 6 weeks. Advanced Ph.D. students in clinical psychology and the Principal Investigator will deliver the treatment protocol. Participants will complete questionnaires before and after each session to measure autonomic reactivity, lifetime stress, depression, anxiety in response to stress induction, and coping strategies. | 0 | None | 0 | 24 | 0 | 24 | View |
| Wait-list Control | Participants randomized to the wait-list control group will complete the same measures of lifetime stress, autonomic reactivity, depression, anxiety. The identical treatment will be offered to control participants after the 6-week time point. | 0 | None | 0 | 27 | 0 | 27 | View |