DUDE - a universal prevention program for non-suicidal self-injurious behavior in adolescence based on effective emotion regulation: study protocol of a cluster-randomized controlled trial

Abstract

Background Non-suicidal self-injury (NSSI) has become a substantial public health problem. NSSI is a high-risk marker for the development and persistence of mental health problems, shows high rates of morbidity and mortality, and causes substantial health care costs. Thus, there is an urgent need for action to develop universal prevention programs for NSSI before adolescents begin to show this dangerous behavior. Currently, however, universal prevention programs are lacking. Methods The main objective of the present study is to evaluate a newly developed universal prevention program (“DUDE – Du und deine Emotionen / You and your emotions”), based on a skills-based approach in schools, in 3200 young adolescents (age 11–14 years). The effectiveness of DUDE will be investigated in a cluster-randomized controlled trial (RCT) in schools (N = 16). All groups will receive a minimal intervention called “Stress-free through the school day” as a mental health literacy program to prevent burnout in school. The treatment group (N = 1600; 8 schools) will additionally undergo the universal prevention program DUDE and will be divided into treatment group 1 (DUDE conducted by trained clinical psychologists; N = 800; 4 schools) and treatment group 2 (DUDE conducted by trained teachers; N = 800; 4 schools). The active control group (N = 1600; 8 schools) will only receive the mental health literacy prevention. Besides baseline assessment (T0), measurements will occur at the end of the treatment (T1) and at 6- (T2) and 12-month (T3) follow-up evaluations. The main outcome is the occurrence of NSSI within the last 6 months assessed by a short version of the Deliberate Self-Harm Inventory (DSHI-9) at the 1-year follow-up (primary endpoint; T3). Secondary outcomes are emotion regulation, suicidality, health-related quality of life, self-esteem, and comorbid psychopathology and willingness to change. Discussion DUDE is tailored to diminish the incidence of NSSI and to prevent its possible long-term consequences (e.g., suicidality) in adolescents. It is easy to access in the school environment. Furthermore, DUDE is a comprehensive approach to improve mental health via improved emotion regulation. Trial registration German Clinical Trials Register (DRKS) DRKS00018945. Registered on 01 April 2020, https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00018945

Mental disorders at the beginning of adolescence: Prevalence estimates in a sample aged 11-14 years

“…Data was drawn from the baseline assessment of a large prevention study and took place at seven German high schools [ 41 ]. Inclusion criteria were being in the 6 th or 7 th grade and informed consent of legal guardians and participating adolescents.…”

School‐based self‐harm prevention programs: A systematic review with implications for international implementation

“…Another possible explanation for why so few programs were identified through our repeated searches is that earlier generations may not have broadly recognized the need for school‐based suicide and self‐harm prevention programs. Four of the seven studies the first and last authors reviewed in 2022 were protocol papers (Buerger, Emser, Seidel et al ., 2022; Byrne, Bailey, Lamblin et al ., 2022; Mascayano, Schilling, Tapia et al ., 2018; Pérez, Elices, Toll et al ., 2020). The emergence of new RCT research suggests that awareness of the need for school‐based prevention programs may be increasing and that promising developments are forthcoming.…”

Emotional dysregulation and its pathways to suicidality in a community-based sample of adolescents

“…The overall sample comprised n = 2350 adolescents and was drawn from the baseline survey (T0) of a cluster-randomized controlled trial evaluating the effectiveness of the universal prevention program “DUDE” [ 25 ]. The inclusion criterion was provision of informed consent from the adolescents and their legal guardians.…”

“…Study procedures were reviewed and approved by the Clinic for Child and Adolescent Psychiatry Wuerzburg, Germany (German Clinical Trials Register: DRKS00018945) and ethically approved by both the ethics committee in Wuerzburg (127/19-me) and the Ministry of Education and Cultural Affairs (IV.7-BO5106/200/12). Procedure-related details are available elsewhere [ 25 ].…”

“…For better interpretability of the model, only the data on SS in the last two weeks were considered. Although no psychometric properties can be identified in the literature [ 25 ], the PSS has been used to evaluate suicidality in both adults and adolescents [ 29 – 31 ].…”