IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli
Brescia, 25125, Italy
NCT Number: NCT04349709
This is a prospective randomized study with twofold aim. The first aim is to evaluate the impact of a school-based intervention focused on emotional regulation skills according to Dialectical Behavior Therapy for Adolescents. To this purpose, a sample of students attending the third year of high school (10th grade; 16-19 years) will be recruited, and the interventions will be delivered to the class of students during school-time. The outcomes will be evaluated (post-intervention, 3 and 6-months follow-up) in term of frequency of dysfunctional behaviours, use of emotional regulation skills, and psychological wellbeing. The study is also aimed to identify clinical and biological markers associated to ED in adolescents. To this purpose, youth psychiatric outpatients (16-19 years) will be recruited and compared to the participants of the community sample. All the participants will be evaluated through a comprehensive assessment including both clinical variables and biological variables. Biological evaluations will be conducted to measure cortisol levels during the day (awakening, noon and evening) and the inflammatory profiles
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Notify Me16 year–19 year
All sexes
Interventional
Not applicable
Brescia, 25125, Italy
Emotional dysregulation (ED) is a multidimensional construct including lack of awareness and clarity about experienced emotions, nonacceptance of emotional distress, impulsivity, inability to pursue goals when emotionally distressed, and lack of regulatory strategies (Gratz and Roemer, 2004).
The background of the present study is threefold:
The main aim of the present study aims to evaluate the impact of an intervention based on Dialectical Behavior Therapy for Adolescents (DBT-A) (Rathus & Miller, 2015, Mazza, et al, 2016) that will be delivered to the class of students during school-time. A total of 426 students attending the third year of high school (10th grade; 16-19 years) will be recruited. In order to optimize the representativeness of the sample, different type of school (i.e. professional institute; technical institute; arts, scientific and classical high schools) will be invited to participate to the study. Moreover, the randomization will be carried out in each school in order to control potential confounding variables associated to a specific type of school. Outcome will be assessed post-intervention, 3 and 6-month follow-up.
The second aim of the present study is to identify clinical and biological markers associated to ED. To this purpose, a clinical sample of youth outpatients (16-19 years) with mental disorders will be recruited and will be compared to the students of the community sample. All the participants will be evaluated through a comprehensive assessment including both clinical variables and biological variables. Clinical assessment will cover different domains: sociodemographic data, emotional dysregulation, psychopathological symptoms, social functioning, childhood trauma, stressful life events during previous year. Biological evaluations will be conducted to measure cortisol levels during the day (awakening, noon and evening) and the inflammatory profiles. Data about biological parameters will permit to investigate whether alterations in biological features related to stress response and inflammation can underlie ED and the vulnerability for psychopathology. Moreover, the same set of biomarkers will be evaluated at the end of the intervention in order to evaluate whether clinical improvements can occur via le modulation of these pathways.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The intervention is inspired to Dialectical Behavior Therapy for Adolescents (DBT-A) (Rathus & Miller, 2015, Mazza et al, 2016; Cappelluccio, 2019). It consists in four monthly 2-hour sessions (for a total of 8 hours) scheduled during school-time. All the sessions are conducted by two psychotherapists trained about DBT. During the sessions, the model of emotions is described through a role-play between conductors. Subsequently, teens are trained about main emotional regulation skills. Moreover, basic elements of distress tolerance, mindfulness and interpersonal efficacy are introduced too.
Time frame: 5, 8, 11 months
The Checklist for dysfunctional, impulsive behaviors is an had-hoc created instrument to measure the dysfunctional/impulsive behaviours (e.g. binge drinking, substance use, unprotected sex, self-harm, etc). For each behaviour, participants are asked to fill the frequency of dysfunctional/impulsive over the previous month
Time frame: 5, 8, 11 months
The DBT-WCCL is a 59-item self-report instrument measuring the frequency of DBT skills use (DBT Skills Subscale, 38 items) and dysfunctional non-DBT coping strategies (Dysfunctional Coping Subscale, 21 items) over the previous month.
Time frame: 5, 8, 11 months
The SPSI-R:SF is a 25-item self-report questionnaire, with five subscales that assess functional and dysfunctional cognitive and emotional orientations towards solving life problems. The subscales are: positive problem orientation (PPO), negative problem orientation (NPO), rational problem solving (RPS), impulsivity-carelessness style (ICS), avoidant style (AS). Higher scores on the NPO, ICS and AS reflect a more maladaptive approach to problem solving; whereas higher scores on the PPO and RPS indicate more adaptive problem solving (D'Zurilla et al., 2002).
Time frame: 5, 8, 11 months
The PHQ is a 9-item self-report questionnaire that cover depressive symptoms criteria of the 9 DSM-IV. A global score is computed as the sum of the nine item and it can range from 0 to 27. Different level of severity of depression can be distinguished according to cut-off (Kroenke et al., 2001).
Time frame: 5, 8, 11 months
The DERS is a 36-item self-report questionnaire with six subscales that assess dimensions of emotional dysregulation: (1) Non-acceptance of emotional responses (6 items); (2) Difficulties engaging in goal-directed behaviour (5 items); (3) Impulse control difficulties (6 items); (4) Lack of emotional awareness (6 items); (5) Limited access to emotion regulation strategies (8 items); (6) Lack of emotional clarity (5 items).
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Other
Emotional Dysregulation in Adolescents: Clinical and Biological Correlates.
Acronym: EmoTIConS
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