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Emotional Regulation in Teens: Improvement of Constructive Skills

NCT04349709 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 462

Last updated 2024-03-07

No results posted yet for this study

Summary

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

Conditions

  • Emotional Dysregulation

Interventions

BEHAVIORAL

Brief school-based DBT-A

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.

Sponsors & Collaborators

  • IRCCS Centro San Giovanni di Dio Fatebenefratelli

    lead OTHER

Principal Investigators

  • Laura Pedrini, PhD · IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-25
Primary Completion
2023-10-30
Completion
2023-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04349709 on ClinicalTrials.gov