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 |
|---|---|---|---|---|---|---|---|---|
| Whole Person Care (WPC) Reentry Program | In partnership with LA County Health Agency, Dr. Barnert is adapting the successful Transitions Clinic model developed for reentry adults, to assist recently incarcerated transition age youth link to needed health services and reduce substance use disorder relapse and recidivism. This adaption is informed by Dr. Barnert's prior research on the needs of incarcerated adolescents. The intervention, called the "Whole Person Care (WPC) Reentry Program" will consist of community health workers (i.e. network coaches) who are formerly incarcerated and formally trained in care coordination and social network coaching, who interact with justice-involved transition age youth pre- and post-release to increase youths' engagement in community SUD and mental health services. Participants in this branch will include youth exiting the adult justice system (ages 18-24). Whole Person Care (WPC) Reentry Program: Social network intervention to provide care coordination and social support during youth reentry. | 0 | None | 0 | 0 | 0 | 0 | View |
| Control | Participants in the control arm will receive usual care reentry healthcare planning post-release, including correctional health provider and court-referred SUD and mental health treatment recommendations, medication prescriptions, written instructions for reinstating Medicaid, and written health discharge summaries. Participants in this branch will include youth exiting the adult justice system (ages 18-24) and youth exiting the juvenile justice system (ages 16-18). | 0 | None | 0 | 19 | 0 | 19 | View |