Emotional Intelligence Intervention to Improve Mental Well-Being of Adolescents With Emotional Distress (BEAM): Study Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Improve well-being
研究概览
简要总结
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.
详细描述
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 during the 2025-2026 academic year. 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 2026 to december 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Due to the difficulty of masking conditions, the groups and participating personnel (research team) will not be blinded.
入排标准
- 年龄范围
- 14 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Control group (non 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.
Intervention group (multicomponent intervention)
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.
干预措施: BEAM (Behavioral)
结局指标
主要结局
Improve well-being
时间窗: Baseline (T0), post-intervention (9 weeks) (T1), and 24 weeks follow-up (T2)
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.
次要结局
- 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))
研究者
Maria Llistosella
Principal Investigator
Consorci Sanitari de Terrassa