An Internet-based emotion regulation intervention versus no intervention for non-suicidal self-injury in adolescents: a statistical analysis plan for a feasibility randomised clinical trial.

BACKGROUND: Non-suicidal self-injury (NSSI) has a lifetime prevalence of 17% in adolescents in the general population and up to 74% in adolescents with psychiatric disorders. NSSI is one of the most important predictors of later suicidal behaviour and death by suicide. The TEENS feasibility trial was initiated to assess the feasibility and safety of Internet-based Emotion Regulation Individual Therapy for Adolescents (ERITA) as an add-on to treatment as usual in 13-17-year-old patients with NSSI referred to the Child and Adolescent Mental Health Services. METHODS: The TEENS feasibility trial is a randomised clinical trial with a parallel-group design. The trial intervention is an 11-week online therapy which is tested as an add-on to treatment as usual versus treatment as usual. The primary feasibility outcomes are the fraction of participants who (1) completed 12 weeks of follow-up interview or assessment, (2) consented to inclusion and randomisation out of all eligible participants, and (3) were compliant with the experimental intervention, assessed as completion of at least six out of eleven modules in the programme. Since this is a feasibility trial, we did not predefine a required sample size. The exploratory clinical outcome, the frequency of NSSI episodes, assessed using Deliberate Self-Harm Inventory - Youth version (DSHI-Y), at the end of intervention, is planned to be the future primary outcome in a larger pragmatic definitive randomised clinical trial. After completion of the feasibility trial, blinded data will be analysed by two independent statisticians blinded to the intervention, where 'A' and 'B' refer to the two groups. A third party will compare these reports, and discrepancies will be discussed. The statistical report with the analyses chosen for the manuscript is being tracked using a version control system, and both statistical reports will be published as a supplementary material. Based on the final statistical report, two blinded conclusions will be drawn by the steering group. DISCUSSION: We present a pre-defined statistical analysis plan for the TEENS feasibility trial, which limits bias, p-hacking, data-driven interpretations. This statistical analysis plan is accompanied by a pre-programmed version-controlled statistical report with simulated data, which increases transparency and reproducibility. TRIAL REGISTRATION: ClinicalTrials.gov NCT04243603 . Registered on 28 January 2020.

Experiences of an Online Treatment for Adolescents With Nonsuicidal Self-injury and Their Caregivers: Qualitative Study.

BACKGROUND: Nonsuicidal self-injury (NSSI) is common in adolescence and is associated with several adverse outcomes. Despite this, few established treatment options exist. Online treatment seems promising for several conditions; however, knowledge on NSSI is scarce. It is important to explore how online treatment for NSSI is experienced to improve such interventions and learn more about factors that are important in the treatment of adolescents with NSSI. OBJECTIVE: This study aims to explore the experiences of a novel online treatment for adolescents with NSSI and their caregivers. METHODS: A qualitative study using thematic analysis was conducted through semistructured interviews with 9 adolescents and 11 caregivers at treatment termination or at the 6-month follow-up of the online emotion regulation individual therapy for adolescents. RESULTS: A total of 3 overarching themes were identified. The theme support can come in different shapes showed how support could be attained through both interaction with the therapist as well as through the format itself (such as through the fictional characters in the material and the mobile app). Caregivers found it helpful to have their own online course, and adolescents accepted their involvement. The theme self-responsibility can be empowering as well as distressing showed that self-responsibility was highly appreciated (such as deciding when and how to engage in treatment) but also challenging; it caused occasional distress for some. The theme acquiring new skills and treatment effects showed the advantages and challenges of learning several different emotion regulation skills and that decreased emotion regulation difficulties were important treatment outcomes for adolescents. In addition, several different skills seemed to facilitate emotion regulation, and having access to such skills could hinder NSSI. CONCLUSIONS: Online emotion regulation individual therapy for adolescents seems to offer an accepted way to deliver family interventions for this target group; facilitate skills training with several means of support, including support from both the mobile app and the therapist; contribute to decreasing emotion regulation difficulties and teaching skills that could hinder NSSI; and cause (in some individuals) distress because of the self-responsibility that is inherent to online formats, which needs to be addressed.