No abstract

Schizophrenia is a devastating chronic disorder that typically presents in early adult life and impacts on a broad swathe of social and psychological functioning. It is not surprising that psychiatrists have tended to be circumspect about making this ominous diagnosis in children and adolescents. Genuine concerns about the validity of applying ‘adult’ psychotic diagnoses in this young age group, together with the lack of diagnosis-specific interventions, have suggested a cautious approach to diagnosis. Furthermore, the relative rarity of schizophrenia in this age group has meant that most psychiatrists have relatively little experience with ‘atypical’ early presentation of the disorder.

Background To contextualize the benefits of an intervention, it is important that adverse events (AEs) are reported. This is potentially difficult in trials of digital mental health interventions, where delivery may be remote and the mechanisms of actions less understood. Objective We aimed to explore the reporting of AEs in randomized controlled trials of digital mental health interventions. Methods The International Standard Randomized Controlled Trial Number database was searched for trials registered before May 2022. Using advanced search filters, we identified 2546 trials in the category of mental and behavioral disorders. These trials were independently reviewed by 2 researchers against the eligibility criteria. Trials were included where digital mental health interventions for participants with a mental health disorder were evaluated through a completed randomized controlled trial (protocol and primary results publication published). Published protocols and primary results publications were then retrieved. Data were extracted independently by 3 researchers, with discussion to reach consensus when required. Results Twenty-three trials met the eligibility criteria, of which 16 (69%) included a statement on AEs within a publication, but only 6 (26%) reported AEs within their primary results publication. Seriousness was referred to by 6 trials, relatedness by 4, and expectedness by 2. More interventions delivered with human support (9/11, 82%) than those with only remote or no support (6/12, 50%) included a statement on AEs, but they did not report more AEs. Several reasons for participant dropout were identified by trials that did not report AEs, of which some were identifiable or related to AEs, including serious AEs. Conclusions There is significant variation in the reporting of AEs in trials of digital mental health interventions. This variation may reflect limited reporting processes and difficulty recognizing AEs related to digital mental health interventions. There is a need to develop guidelines specifically for these trials to improve future reporting.

IMPORTANCEThe availability of behavior therapy for individuals with Tourette syndrome (TS) and chronic tic disorder (CTD) is limited. OBJECTIVE To determine the efficacy and cost-effectiveness of internet-delivered exposure and response prevention (ERP) for children and adolescents with TS or CTD. DESIGN, SETTING, AND PARTICIPANTS This single-masked, parallel group, superiority randomized clinical trial with nationwide recruitment was conducted at a research clinic in Stockholm, Sweden.