Adverse events and trial management
deaths, psychiatric, accidents
ADVERSE EVENTS
The occurrence of specific serious adverse events (SAEs) according to War Child’s operational definition (including deaths; suicide attempts; victimization including physical, sexual and emotional abuse or neglect; serious violence; emergency psychiatric or medical hospitalisation; or serious lack of food) and adverse events (AEs; including injuries or accidents on way to or from the research activities; marked increases in suicidal thoughts; mentioning of concrete and detailed plan to commit suicide; marked increases in emotional distress; marked increases in conflicts within family or community; other violence towards staff or participants) were monitored throughout the study by field-based research and implementation teams. They were reported using structured incident report forms submitted to the lead investigators, who then reported to the Data Safety Management Committee (DSMC) and relevant ethical boards. The trial coordinator provided daily supervision and oversight to assessors during data collection. Weekly study meetings between the research coordinator and study investigators ensured adequate support for implementation, fidelity to protocol, and trial safety.