Clinical trial NCT06713460: Emotional Intelligence Intervention to Improve Mental Well-Being of Adolescents With Emotional Distress (BEAM)
Official title: Assessment of a Multicomponent Intervention Based on Emotional Intelligence to Improve Mental Well-being in Adolescents With Emotional Distress: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Emotional Distress
Keywords: Mental Well-being
Emotional Intelligence
Emotional Distress
Adolescents
Lead sponsor: Consorci Sanitari de Terrassa
Sponsor class: OTHER
First posted: 2024-12-03
Enrollment: 104
Sex: ALL
Minimum age (years): 14
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to either the control or intervention group by an external investigator through computer-generated random numbers.
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to assess the effectiveness of a multicomponent intervention in adolescents with emotional distress. The main question it aims to answer is:

Does the intervention increase mental well-being, emotional resilience, and emocional intelligence in adolescents with emotional distress?

Participants will:

• Participate in a multi-component intervention for 9 weeks at school.

Detailed description: Background:Adolescence involves biological, psychological and social transformations that increase vulnerability to mental health problems. Emotional intelligence is a protective factor that improves mental well-being. Given the sensitivity of adolescence to mental health disorders, emotional intelligence emerges as a valuable tool for promoting mental well-being.The investigators hypothesize that adolescents aged 14-16 with emotional distress who receive the multicomponent intervention based on emotional intelligence will obtain better scores on the Warwick-Edinburgh Mental Well-being Scale compared to the control group, after the intervention and at 24 weeks post-intervention.

Method :The study is a Randomized Controlled Trial (RCT). The participants and their parents will sign an agreement to participate in the study and will be randomly allocated in control and intervention groups by external researcher using a computer-generated random number. The intervention will be conducted in a school setting between April and November 2025. It will comprise a multicomponent program consisting of nine sessions, each lasting 55 minutes, addressing various topics related to emotional intelligence. Data will be collected from April 2025 to April 2026."Three psychometric scales will be used: Warwick-Edinburgh Mental Wellbeing Scale (WEMWB), Trait Meta-Mood Scale (TMMS-24) and Child Youth Resilience Measure (CYRM-32), with measurements before the intervention (T0), 9 (T1) and 24 weeks follow-up (T2).The group receiving the intervention is expected to show improvements in emotional well-being, emotional intelligence and resilience compared to the control group.

Accepting an alpha risk of 0.05 and a beta risk of 0.20 in a bilateral contrast, 52 subjects in the first group and 52 in the second group are required to detect a difference equal to or greater than 5 units on the WEMWBS scale. A common standard deviation of 6.8 is assumed. A loss to follow-up rate of 0.1 (10%) and a correlation between observations of 0.4 was estimated.

Eligibility criteria: Inclusion Criteria:

* Adolescents with emotional distress scores on the Warwick-Edinburgh Mental Well- being Scale.
* Adolescents aged 14-16 ( in 9th Grade).
* Informed consent form signed (by adolescents and their parent or legal guardian)

Exclusion Criteria:

* Physical illnesses that prevent attendance at scheduled sessions, severe mental disorders (such as Autism Spectrum Disorder, major depression, schizophrenia).
* No comprehension of the language
* Lack of consent from the adolescents or their parents or legal guardians

Primary outcomes:
measure: Improve well-being
timeFrame: Baseline (T0), post-intervention (9 weeks) (T1), and 24 weeks follow-up (T2)
Secondary outcomes:
measure: Increased resilience
timeFrame: Baseline (T0), post-intervention (9 weeks) (T1), and 24 weeks follow-up (T2)
measure: Increase emotional intelligence
timeFrame: Baseline (T0), post-intervention (9 weeks) (T1), and 24 weeks follow-up (T2)
Other outcomes:
Locations:
city: Terrassa
country: Spain
facility: Consorci Sanitari de Terrassa
state: Barcelona
city: Terrassa
country: Spain
facility: Institut Can Roca
state: Barcelona
Study officials:
affiliation: Primary Health Care, Consorci Sanitari de Terrassa
name: Maria Llistosella, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gracia R, Pamias M, Mortier P, Alonso J, Perez V, Palao D. Is the COVID-19 pandemic a risk factor for suicide attempts in adolescent girls? J Affect Disord. 2021 Sep 1;292:139-141. doi: 10.1016/j.jad.2021.05.044. Epub 2021 May 27.
citation: Llistosella M, Gutierrez-Rosado T, Rodriguez-Rey R, Liebenberg L, Bejarano A, Gomez-Benito J, Limonero JT. Adaptation and Psychometric Properties of the Spanish Version of Child and Youth Resilience Measure (CYRM-32). Front Psychol. 2019 Jun 28;10:1410. doi: 10.3389/fpsyg.2019.01410. eCollection 2019.
citation: Salguero, J. M., Fernández-Berrocal, P., Balluerka, N., & Aritzeta, A. (2010). Measuring perceived emotional intelligence in the adolescent population: Psychometric properties of the Trait Meta-Mood Scale. Social Behavior and Personality: an international journal, 38(9), 1197-1209
citation: Castellvi P, Forero CG, Codony M, Vilagut G, Brugulat P, Medina A, Gabilondo A, Mompart A, Colom J, Tresserras R, Ferrer M, Stewart-Brown S, Alonso J. The Spanish version of the Warwick-Edinburgh mental well-being scale (WEMWBS) is valid for use in the general population. Qual Life Res. 2014 Apr;23(3):857-68. doi: 10.1007/s11136-013-0513-7. Epub 2013 Sep 5.
citation: Dominguez-Garcia E, Fernandez-Berrocal P. The Association Between Emotional Intelligence and Suicidal Behavior: A Systematic Review. Front Psychol. 2018 Nov 30;9:2380. doi: 10.3389/fpsyg.2018.02380. eCollection 2018.