Research recommendations for assessing potential harm from universal school-based mental health interventions

There is growing evidence that universal school-based mental health interventions can lead to negative outcomes in young people. This is a critical ethical issue, especially when young people cannot easily opt out of interventions run during school hours. So far, however, there is no guidance available about potential harms for researchers designing and running these interventions. In this Perspective, we set out five research recommendations: (1) acknowledge the possibility of potential harms; (2) identify types of potential harms; (3) measure and report potential harms in all outputs; (4) consider adverse events (for example, a suicide attempt); and (5) consider participant dropout and disengagement. Using simulated data, we demonstrate that even if trials show small negative effects, this could lead to considerable harm if interventions are scaled up across the population. Furthering research in this area will help ensure the field delivers interventions that are most effective and least harmful for everyone.