NCT04349709: EmoTIConS

Emotional Regulation in Teens: Improvement of Constructive Skills

Completed NA Last updated 7 March 2024

What this trial tests

NA trial testing Brief school-based DBT-A in Emotional Dysregulation in 462 participants. Completed in 31 December 2023.

Timeline

25 November 2019

Primary endpoint
30 October 2023

31 December 2023

Quick facts

Lead sponsor	IRCCS Centro San Giovanni di Dio Fatebenefratelli
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	462
Start date	25 November 2019
Primary completion	30 October 2023
Estimated completion	31 December 2023
Sites	1 location across Italy

Drugs / interventions tested

• Brief school-based DBT-A

Conditions studied

• Emotional Dysregulation — all drugs for Emotional Dysregulation →

Sponsor

IRCCS Centro San Giovanni di Dio Fatebenefratelli

Who can join

Adults 16 to 19, any sex, with Emotional Dysregulation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Adolescents' mental health and maladaptive behaviors before the Covid-19 pandemic and 1-year after: analysis of trajectories over time and associated factors.
   Pedrini L, Meloni S, Lanfredi M, Ferrari C, et al · · 2022 · cited 25× · PMID 35689203 · DOI 10.1186/s13034-022-00474-x
2. Emotional Regulation in Teens and Improvement of Constructive Skills (EmoTIConS): study protocol for a randomized controlled trial.
   Pedrini L, Rossi R, Magni LR, Lanfredi M, et al · · 2021 · cited 3× · PMID 34906222 · DOI 10.1186/s13063-021-05886-2
3. The Associations between Lifestyle Habits and Anxiety: A Prospective Study on Adolescents One Year after the Outbreak of the COVID-19 Pandemic.
   Pedrini L, Meloni S, Dawson J, Geviti A, et al · · 2024 · cited 1× · PMID 38539317 · DOI 10.3390/children11030282
4. Emotional Regulation In Teens And Improvement of Constructive Skills (EmoTIConS): Study Protocol For A Randomized Controlled Trial
   Pedrini L, Rossi R, Magni LR, Lanfredi M, et al · · 2021 · DOI 10.21203/rs.3.rs-543777/v1