Emotional Regulation in Teens and Improvement of Constructive Skills (EmoTIConS): study protocol for a randomized controlled trial

Background: Emotional dysregulation (ED) constitutes a relevant factor involved in the onset and maintenance of many mental disorders. Targeting ED during adolescence could be a determinant both to identify high-risk individuals and to promote preventive interventions. This study will aim to evaluate the impact of a brief Dialectical Behavioral Therapy (DBT)-based intervention for adolescent students by measuring changes in emotional regulation skills and impulsive behaviors. Moreover, alterations in biological features related to stress response and inflammation will be assessed as potential biological variables associated with ED. Methods: This is a randomized trial. A total of 20 classes of adolescent students will be recruited among high schools in Brescia, a city in northern Italy. They will be randomized to the psychoeducational intervention (experimental group) or to a control condition (control group). The intervention will be based on DBT Skills Training for Emotional Problem Solving for Adolescents, and will consist of four monthly, 2-h sessions (for a total of 8 h) scheduled during regular school time. Participants will be assessed at baseline, post-intervention, and at 3 and 6 months of follow-up. The primary outcome measures will be represented by changes in the use of emotional regulation skills and by changes in the frequency of impulsive behaviors. Salivary samples will be collected at baseline and post-intervention to explore possible biological features underlying ED. Discussion: Data from the present project will offer the opportunity to better understand the complex phenomenon of ED. Repeated assessment will cover several domains (emotional, behavioral, social, biological) as potential factors associated with ED. Moreover, it will be possible to establish the effect of the proposed intervention, thus helping to improve knowledge on the impact of school-based universal preventive programs. Finally, the current trial will propose an integrated screening and intervention-based model. Ultimately, this could reduce barriers to youths’ mental health care by fostering collaboration between schools and mental health services. Trial registration: ClinicalTrials.gov NCT04349709. Registered on April 16, 2020.