NCT06713460

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Apr 2025

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress63%
Apr 2025Dec 2026

First Submitted

Initial submission to the registry

November 27, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 3, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

April 7, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

1.5 years

First QC Date

November 27, 2024

Last Update Submit

April 15, 2026

Conditions

Keywords

Mental Well-beingEmotional IntelligenceEmotional DistressAdolescents

Outcome Measures

Primary Outcomes (1)

  • Improve well-being

    Changes in level of well-being using the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS). Values range from 14 to 70 . Higher scores, better outcome.

    Baseline (T0), post-intervention (9 weeks) (T1), and 24 weeks follow-up (T2)

Secondary Outcomes (2)

  • Increased resilience

    Baseline (T0), post-intervention (9 weeks) (T1), and 24 weeks follow-up (T2)

  • Increase emotional intelligence

    Baseline (T0), post-intervention (9 weeks) (T1), and 24 weeks follow-up (T2)

Study Arms (2)

Intervention group (multicomponent intervention)

EXPERIMENTAL

A multi-component group intervention, based on Mayer and Salovey's emotional skills model, will target adolescents with emotional distress. Led by the Community Emotional Well-Being Coordinator and supported by a nurse, physiotherapist, and educational psychologist, the intervention will occur during the 2025-2026 academic year in Consorci Sanitari de Terrassa institutes. It will consist of nine 55-minute sessions during school hours, supplemented by voluntary home activities. The program will focus on emotional identification and regulation, structured around seven components: goal-setting, positive thinking, self-awareness, self-esteem, willpower, mindfulness, and assertiveness.

Behavioral: BEAM

Control group (non intervention)

NO INTERVENTION

Participants in the control group will complete the same research questionnaires as the intervention group during the same period. Control group participants will undergo the intervention (if effective) in the following academic year (January - June 2027), when they are in 10th Grade.

Interventions

BEAMBEHAVIORAL

Multicomponent intervention

Intervention group (multicomponent intervention)

Eligibility Criteria

Age14 Years - 16 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Consorci Sanitari de Terrassa

Terrassa, Barcelona, 08227, Spain

RECRUITING

Institut Can Roca

Terrassa, Barcelona, 08227, Spain

RECRUITING

Related Publications (5)

  • 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.

    PMID: 34119869BACKGROUND
  • 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.

  • 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

    RESULT
  • 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.

  • 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.

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Maria Llistosella, PhD

    Primary Health Care, Consorci Sanitari de Terrassa

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mamen Carmona, PhD

CONTACT

Ramon Roca, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Due to the difficulty of masking conditions, the groups and participating personnel (research team) will not be blinded.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to either the control or intervention group by an external investigator through computer-generated random numbers.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 27, 2024

First Posted

December 3, 2024

Study Start

April 7, 2025

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

April 20, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Fully anonymised overall results will be shared.

Locations