How have contemporary studies evaluating self-help digital mental health interventions for young people monitored and reported on adverse events and harms?: a systematic scoping review.

Background: Many digital mental health interventions (DMHIs) can be effective in reducing symptoms of common mental health problems in young people and can overcome many barriers to accessing treatment. These are most scalable when offered as self-help. However, all mental health interventions have the potential to cause harm, and this should be monitored. Aim: To identify current practices and gaps in safety reporting, we systematically mapped how adverse events have been monitored and reported in contemporary studies evaluating self-guided DMHIs for young people. Method: We conducted a systematic scoping review. Two databases were searched for relevant studies published between 2019 and 2024. We synthesised the findings narratively, drawing on content analysis to identify patterns. Results: We included 37 studies, 12 (32.4%) of which described how they assessed adverse events (AEs). AEs were identified through worsening on wellbeing/psychometric measures, measures of risk and suicidal ideation/behaviour, participants self-identifying AEs, and parental reporting of AEs. Additionally, some studies reported on the proportion of participants experiencing AEs, with 8 (21.6%) studies reporting adverse events as an outcome. The most commonly occurring AEs reported were hospitalisation, treatment non-response, depressive symptoms, and significant worsening of symptoms (each 5.4% respectively). Other AEs reported were self-harm, substance misuse, anxiety symptoms, suicidal thoughts, suicide attempt and headaches (each 2.7% respectively). Conclusion: Despite the potential for adverse events to occur while young people are using self-guided DMHIs, our review highlighted a gap in the monitoring of and reporting of adverse events in these kinds of intervention studies.