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 |
|---|---|---|---|---|---|---|---|---|
| Adolescents | Adolescents with PHQ-9 scores between 5 and 20 who do not report current suicidality (Pine et al., 1999) will be recruited from clinician target users' practice settings. The investigators will recruit new adolescents for each Aim to decrease bias in feedback and outcomes. Behavioral Activation: Intervention: Behavioral Activation (BA) therapy is based on a functional analytic model of depression that highlights the need for increased positive reinforcement (rewards) and decreased anhedonia, or diminished motivation to seek rewards, to maintain normal mood. BA is significantly more effective than Cognitive Behavioral Therapy and comparable to antidepressant medication in reducing depressive symptoms among depressed adults (Dimidjian et al., 2006). McCauley (senior mentor) et al. (2016) adapted BA for adolescents to target anhedonia, effective problem solving and avoidant behaviors with peers, family, and school. McCauley's findings and others show BA is a promising intervention for adolescent MDD (Chu et al., 2009; Cuijpers et al.,, 2007; McCauley et al., 2015; Ritschel et al., 2011). BA focuses on targeting ideographically identified avoidant behaviors and rewarding experiences that affect mood. | 0 | None | 0 | 11 | 0 | 11 | View |