Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-26 @ 12:38 AM
Study NCT ID:
NCT06713460
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-13
First Post:
2024-11-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Emotional Intelligence Intervention to Improve Mental Well-Being of Adolescents With Emotional Distress (BEAM)
Sponsor:
Consorci Sanitari de Terrassa
Organization:
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BEAM
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.
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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: