Emotional Regulation in Teens: Improvement of Constructive Skills

NCT04349709 | Completed DMC

• 1 other identifier: GR-2018-12366754
• Study Type: interventional
• Target: 462
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Adolescence; Dialectical behavior therapy; stress; school-based intervention; psychoeducation; cortisol; inflammation

Outcome Measures

Primary Outcomes (2)

• Change in dysfunctional/impulsive behaviours measured by Checklist for dysfunctional, impulsive behaviours.

  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

  5, 8, 11 months

• Change in emotional regulation skills measured by the DBT-Ways of Coping Checklist (DBT-WCCL).

  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.

  5, 8, 11 months

Secondary Outcomes (3)

• Change in problem-solving strategies as detected by change in mean scores on Social Problem-Solving Inventory-Revised Short Form (SPSI-R:SF) (Maydeu-Olivares & D'Zurilla 1996)

  5, 8, 11 months

• Change in depressive symptoms as detected by change in mean Patient Health Questionnaire PHQ-9 global score.

  5, 8, 11 months

• Change in emotional dysregulation as detected by change in mean scores on the Difficulties in Emotion Regulation Scale (DERS) (Gratz and Roemer, 2004).

  5, 8, 11 months

Study Arms (2)

Brief school-based DBT-A

EXPERIMENTAL

The students of classes randomized to experimental group receive the brief school-based DBT-A..

Behavioral: Brief school-based DBT-A

control group

NO INTERVENTION

The students of classes randomized to control group continue their school activity as routine.

Interventions

Brief school-based DBT-A BEHAVIORAL

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.

Brief school-based DBT-A

Eligibility Criteria

• Age: 16 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Students attending the third year of high school (10th academic grade)
• Signed consent form

You may not qualify if:

• Mental retardation
• Asperger syndrome
• Autism spectrum disorders

Sponsors & Collaborators

• IRCCS Centro San Giovanni di Dio Fatebenefratelli: lead

Study Sites (1)

IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli

Brescia, 25125, Italy

Location

Related Publications (5)

• Mazza et al, DBT Skills in Schools (DBT STEPS-A). Guilford Publications; 2016

  BACKGROUND

• Rathus&Miller, DBT Skills Manual for Adolescents, Guildford Press; 2015

  BACKGROUND

• Taylor RD, Oberle E, Durlak JA, Weissberg RP. Promoting Positive Youth Development Through School-Based Social and Emotional Learning Interventions: A Meta-Analysis of Follow-Up Effects. Child Dev. 2017 Jul;88(4):1156-1171. doi: 10.1111/cdev.12864.

  PMID: 28685826 BACKGROUND

• Beauchaine TP. Future Directions in Emotion Dysregulation and Youth Psychopathology. J Clin Child Adolesc Psychol. 2015;44(5):875-96. doi: 10.1080/15374416.2015.1038827. Epub 2015 May 27.

  PMID: 26016727 BACKGROUND

• Pedrini L, Rossi R, Magni LR, Lanfredi M, Meloni S, Ferrari C, Macis A, Lopizzo N, Zonca V, Cattaneo A. Emotional Regulation in Teens and Improvement of Constructive Skills (EmoTIConS): study protocol for a randomized controlled trial. Trials. 2021 Dec 14;22(1):920. doi: 10.1186/s13063-021-05886-2.

  PMID: 34906222 DERIVED

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Laura Pedrini, PhD

  IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 10, 2020
• First Posted: April 16, 2020
• Study Start: November 25, 2019
• Primary Completion: October 30, 2023
• Study Completion: December 31, 2023
• Last Updated: March 7, 2024

Record last verified: 2024-03

Locations

IT (1)