How the risk of suicide and non-suicidal self-injury is assessed, monitored and managed in randomised controlled trials of interventions for youth depression: a scoping review

BMJ Open. 2026 Apr 28;16(4):e111993. doi: 10.1136/bmjopen-2025-111993.

ABSTRACT

OBJECTIVES: This scoping review examines randomised controlled trials (RCTs) for young people with depression to explore three key questions: (1) Do RCTs for young people with depression exclude participants based on risk of suicide or self-harm? (2) How is this risk monitored throughout the course of the trial? and (3) When risk is identified, how is this risk managed throughout the RCT?

DESIGN: This project used a scoping review methodology and was conducted in accordance with guidance in the Preferred Reporting Items for Systematic reviews and Meta-Analyses statement.

DATA SOURCES: Four electronic databases (PsycINFO, Ovid MEDLINE, PsychARTICLES and Embase) were searched with sets of search terms.

ELIGIBILITY: Included studies were RCTs evaluating interventions for depressive symptoms in young people (age 18 or under). Studies published between 1988 and 2025, and in English, were included.

DATA EXTRACTION: Papers retrieved were independently screened by two reviewers, first by title and abstract and then full text, in accordance with eligibility criteria. Relevant data were then extracted.

RESULTS: 89 studies were included. Of these, 55.06% (n=49) excluded young people at screening or baseline stages for risk of suicide or self-harm, with four studies excluding over 10% of participants. Overall, 40.45% (n=36) of studies reported monitoring risk during the trial, with the majority (n=24; 66.67%) using psychometric assessment. Most studies that monitored risk took an active approach to managing it, for example, through referral to external clinical services (n=12; 33.33%) or further clinical involvement from the trial team (n=9; 25%).

CONCLUSION: To ensure that RCTs for young people with depression are reliable, safe and can be replicated in clinical settings, there needs to be greater clarity on risk procedures in trials and on the expectations of reporting and monitoring the risk of suicide or self-harm.

TRIAL REGISTRATION NUMBER: The protocol was registered with the Open Science Framework prior to the implementation of the search strategy (https://osf.io/6dz5a; registration DOI: 10.17605/OSF.IO/6DZ5A).

PMID:42049300 | DOI:10.1136/bmjopen-2025-111993