What metrics of harm are being captured in clinical trials involving talking treatments for young people? A systematic review of registered studies on the ISRCTN

Abstract

Objective: The recording of harm and adverse events in psychological trials is essential, yet the types of harm being captured in trials for talking treatments involving children and young people have not been systematically investigated. The aim of this review was to determine how often harm and adverse events are recorded in talking treatments for children and young people, as well as the metrics that are being collected. Method: The ISRCTN was searched for trials involving talking therapies and young people. Of 355 entries, 69 met inclusion criteria. The authors of these records were contacted for further information, and additional searches were conducted of protocols and papers. Results: Findings show that around half of all records mentioned harm or adverse events in at least one piece of study documentation. Overall, metrics commonly collected are as follows: suicide, suicidal ideation and intent, self-harm, changes to clinical symptomology, and the need for further or additional care. Conclusions: Similar to the wider field of psychological interventions for mental health, the recording of harm and adverse events in children and young people tends to rely on a few key metrics, many of which are borrowed from drug trials. Examples of best practice have been highlighted, as well as recommendations for the progression of this research area