Strengthening Emotional Regulation: a Group Intervention with Adolescents

Not Applicable

Recruiting

• Conditions: Emotional Regulation

• Registration Number: NCT06878521
• Lead Sponsor: Lorena Wenger Amengual

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-12
• Status Verified: 2025-01
• Study First Submitted: 2025-01-29
• Study First Submitted QC: 2025-03-12
• Last Update Submitted: 2025-03-12
• Study First Posted: 2025-03-17
• Last Update Posted: 2025-03-17
• Primary Completion: 2025-10-30
• Study Completion: 2025-12-19

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 128

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Emotional Dysregulation Over Time Compared to the Control Group	Day 0 = during enrollment, Month 2 = immediately after the experimental group completes the intervention, and Month 3 = three months later for follow-up	Emotional dysregulation is measured using the "Difficulty in Emotion Regulation Scale" (DERS-E). This self-report questionnaire is administered to participants at baseline (Day 0), at the end of the intervention (Month 2), and three months later for follow-up (Month 3).
Change from Baseline in Psychological Functioning screening Over Time Compared to the Control Group	Day 0 = during enrollment, Month 2 = immediately after the experimental group completes the intervention, and Month 3 = three months later for follow-up	Psychological functioning screening is assessed using the "Strengths and Difficulties Questionnaire" (SDQ) (self-report version), which measures emotional and behavioral difficulties. The minimum value for the general difficulty scale is 0, and the maximum value is 40, where higher scores indicate worse psychological functioning.; This questionnaire is administered to participants at baseline (Day 0), at the end of the intervention (Month 2), and three months later for follow-up (Month 3).
Change from Baseline in Anxiety Symptoms Over Time Compared to the Control Group	Day 0 = during enrollment, Month 2 = immediately after the experimental group completes the intervention, and Month 3 = three months later for follow-up	Anxiety Symptoms are assessed using the "Generalized Anxiety Disorder 7" (GAD-7), which measures the presence and severity of anxiety symptoms. The minimum value for the scale is 0, and the maximum value is 21, where higher scores indicate worse anxiety symptoms.; This questionnaires is administered to participants at baseline (Day 0), at the end of the intervention (Month 2), and three months later for follow-up (Month 3).
Change from Baseline in Depressive Symptoms Over Time Compared to the Control Group	Day 0 = during enrollment, Month 2 = immediately after the experimental group completes the intervention, and Month 3 = three months later for follow-up	The evaluates the severity of depressive symptoms.; Depressive Symptoms are assessed using the "Patient Health Questionnaire 9" (PHQ-9), which measures the severity of depressive symptoms. The minimum value for the scale is 0, and the maximum value is 27, where higher scores indicate worse depressive symptoms.; This questionnaires is administered to participants at baseline (Day 0), at the end of the intervention (Month 2), and three months later for follow-up (Month 3).

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in Clinical Symptoms Over Time Compared to the Control Group, with Masking in the Evaluation Process	Day 0 = during enrollment, Month 2 = immediately after the experimental group completes the intervention	A blinded teacher assessment will be conducted at baseline (Day 0), at the end of the intervention (Month 2) to evaluate symptom levels in both groups, using the "Strengths and Difficulties Questionnaire: Teacher-rated" (SDQ). The minimum value for the general difficulty scale is 0, and the maximum value is 40, where higher scores indicate worse psychological functioning.

Trial Locations

Locations (1)

Universidad de La Frontera; 🇨🇱 Temuco, Chile