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 |
|---|---|---|---|---|---|---|---|---|
| ParentCorps-Professional Development (PD) | n = 6 Schools in Kampala, Uganda (Urban) - 89 Teachers, 325 Parent-Child Pairs \+ n = 10 Schools in Hoima, Uganda (Rural) - 98 Teachers, 344 Parent-Child Pairs ParentCorps-Professional Development (PD): Multi-component school-based intervention that promotes early childhood mental health and development. Teachers (pre-primary to 4th grade) will participate in a 3-day ParentCorps-PD training during the school term. They will also receive 8 sessions (8 hours) of face-to-face group-based coaching during after the training. Coaching sessions are to help teachers apply EBI strategies in their classrooms, engage families, and develop competencies. | 0 | None | 0 | 1525 | 0 | 1525 | View |
| ParentCorps-Professional Development (PD) + T-Wellness | n = 6 Schools in Kampala, Uganda (Urban) - 77 Teachers, 300 Parent-Child Pairs \+ n = 10 Schools in Hoima, Uganda (Rural) - 80 Teachers, 329 Parent-Child Pairs ParentCorps-Professional Development (PD): Multi-component school-based intervention that promotes early childhood mental health and development. Teachers (pre-primary to 4th grade) will participate in a 3-day ParentCorps-PD training during the school term. They will also receive 8 sessions (8 hours) of face-to-face group-based coaching during after the training. Coaching sessions are to help teachers apply EBI strategies in their classrooms, engage families, and develop competencies. T-Wellness: A brief teacher stress management psychoeducation package, adapted from EBIs including one-day workshop for common stress management and stress management, and three follow-up group support sessions (3 additional monthly 1-hr wellness sessions for teachers as a group that were integrated into the 3 of the 8 PD coaching sessions. A total 3 hours of coaching were included. | 0 | None | 0 | 1415 | 0 | 1415 | View |
| Control | n = 6 Schools in Kampala, Uganda (Urban) - 73 Teachers, 316 Parent-Child Pairs \+ n = 9 Schools in Hoima, Uganda (Rural) - 92 Teachers, 321 Parent-Child Pairs | 0 | None | 0 | 1439 | 0 | 1439 | View |