Skip to main content
. Author manuscript; available in PMC: 2011 Aug 30.
Published in final edited form as: Clin Trials. 2010 Feb;7(1):58–68. doi: 10.1177/1740774509356575

Table 2.

AEs for participants

Event Severity Operational definition Resolution
Arrest Non serious Participant arrested Arrest is a clear-cut event that starts and ends with the arrest itself. Therefore, date of onset and date of resolution are the same.
Runaway Non serious Minor leaves home without notice, does not come back, and does not report his/her whereabouts for 24 h The event is resolved when the minor’s parent/guardian knows the child’s whereabouts.
Kicked out of home Non serious Participant who gets thrown out by their family does not have a safe place to go. If minor, the parent/guardian needs to know where the child is The event is resolved when the participant who has been thrown out is in a safe place. For a minor, there is an additional requirement. The minor’s parent/guardian must know where the child is.
School suspension/expulsion/dropout Non serious Minor is suspended (not allowed to go to school for a limited time), expelled (thrown out of their school without the right to return for an indefinite time) or drops out (decides to leave school) These events are clear-cut incidents that start and end with the occurrence of the event. Therefore, the date of onset and the date of resolution are the same
Violence (victim/exposure) Non serious Participant is subjected or exposed to rough or injurious physical force or abuse, action or treatment but does not require medical attention; witness to a violent event, that involve death, serious injury or a real threat to the physical integrity The event is resolved when the violent event or exposure to a violent event ends. Therefore, the date of onset and the date of resolution are the same.
Physical/sexual abuse Serious Injury inflicted by hitting, kicking, burning, shaking or throwing that result in bruises, marks or injuries, that require medical attention; sexual abuse for minors includes any sexual touching and fondling, exposing a child to pornographic materials and or adult sexual activity, having a child pose, undress or perform in a sexual fashion, peeping into bedrooms or bathrooms, rape or attempted rape; sexual abuse for adults is defined as any unwelcome sexual physical contact This AE refers to a physical or sexual abuse incident. Repeated incidents should be reported as separate events. The event is resolved when the physical or sexual abuse incident ends.
Suicidal behavior Serious Suicidal behaviors include any risk or attempt to inflict serious bodily harm to self that may result in death The event is resolved when the Clinical Supervisor or other qualified mental health practitioner determines that there is no further risk.
Homicidal behavior Serious Any attempts to seriously injure or kill another person; ideations that represent a realistic threat to another person Resolution for this serious event will be the remission of homicidality as determined by the Clinical Supervisor or qualified mental health practitioner.
Hospitalization Serious Hospitalization for psychiatric or drug-related reasons Resolution of this event is the discharge from hospital.
Death Serious Deaths of participants This event is a clear-cut incident that starts and ends with the occurrence of the event. Therefore, the date of onset and the date of resolution are the same
Other unexpected adverse event Serious or non serious Any other adverse event serious or non serious Resolution is determined by the Principle Investigator and Clinical Supervisor.