Clinical trial NCT06878521: Strengthening Emotional Regulation: a Group Intervention with Adolescents
Official title: Strengthening Emotional Regulation: a Preliminary Efficacy Study of a Group Intervention with Adolescents [Fortaleciendo La Regulación Emocional: Un Estudio De Eficacia Inicial De Una Intervención Grupal Con Adolescentes]
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Emotional Regulation
Keywords: Adolescents
Emotional regulation
Transdiagnostic
Transdiagnostic intervention
Group intervention
Emotion Regulation Skills Training
School-based intervention
Lead sponsor: Universidad de La Frontera
Sponsor class: OTHER
Collaborators: name: Agencia Nacional de Investigación y Desarrollo
First posted: 2025-03-17
Enrollment: 128
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: This study is a randomized controlled trial (RCT) with a parallel-group design and a waitlist control group. Participants will be randomly assigned to one of two groups:

1. Experimental Group: This group will receive the emotional regulation skills training (ERST) intervention immediately.
2. Control Group: This group will not receive the intervention initially but will be placed on a waitlist and receive the same ERST intervention after the experimental group has completed the program.

This design allows for a direct comparison between the experimental and control groups during the initial intervention period, ensuring that any observed effects can be attributed to the ERST program. The waitlist control group ensures that all participants eventually receive the intervention, maintaining ethical standards.
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to determine the initial efficacy of an emotional regulation skills training (ERST) intervention program in a group of adolescents presenting mild symptoms affecting their ability to regulate emotions. For this purpose, a sample of 1st and 2nd-year high school students (ages 14-16) will be recruited, and the intervention will be conducted on the educational institution's premises during school hours. The main questions it aims to answer are:

Does the ERST intervention reduce symptom levels in adolescents with mild emotional dysregulation? Does the ERST intervention improve emotional regulation skills in adolescents? Researchers will compare pre-intervention (T1) and post-intervention (T2) outcomes, as well as follow-up assessments at 3 months, to evaluate changes in symptom levels and emotional dysregulation. Additionally, a blinded teacher assessment will be conducted at T1 and T2 to evaluate symptom levels.

Participants will:

Attend the ERST intervention sessions during school hours. Complete self-report assessments at four time points (T1, T2, and 3-month follow-up).

Be evaluated by a blinded teacher at T1 and T2.


Eligibility criteria: Inclusion Criteria:

* Adolescents in their first or second year of high school.
* Must be currently enrolled in school.
* They should be referred for emotional dysregulation issues and require mental health support.
* They must score above the 75th percentile on the total scale of the SDQ screening tool

Exclusion Criteria:

* Adolescents who are regularly receiving psychological treatment

Primary outcomes:
measure: Change from Baseline in Emotional Dysregulation Over Time Compared to the Control Group
timeFrame: Day 0 = during enrollment, Month 2 = immediately after the experimental group completes the intervention, and Month 3 = three months later for follow-up
measure: Change from Baseline in Psychological Functioning screening Over Time Compared to the Control Group
timeFrame: Day 0 = during enrollment, Month 2 = immediately after the experimental group completes the intervention, and Month 3 = three months later for follow-up
measure: Change from Baseline in Anxiety Symptoms Over Time Compared to the Control Group
timeFrame: Day 0 = during enrollment, Month 2 = immediately after the experimental group completes the intervention, and Month 3 = three months later for follow-up
measure: Change from Baseline in Depressive Symptoms Over Time Compared to the Control Group
timeFrame: Day 0 = during enrollment, Month 2 = immediately after the experimental group completes the intervention, and Month 3 = three months later for follow-up
Secondary outcomes:
measure: Change from Baseline in Clinical Symptoms Over Time Compared to the Control Group, with Masking in the Evaluation Process
timeFrame: Day 0 = during enrollment, Month 2 = immediately after the experimental group completes the intervention
Other outcomes:
Locations:
city: Temuco
country: Chile
facility: Universidad de La Frontera
Study officials:
References: