Strengthening Emotional Regulation: a Group Intervention With Adolescents
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]
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Temuco, Chile
- Universidad de La Frontera
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Emotional regulation skills training Group
Participants in this group will receive the emotional regulation skills training (ERST) intervention.
|
This intervention is inspired by and incorporates elements of Dialectical Behavior Therapy (DBT). It consists of eight weekly group sessions, each lasting approximately 1.5 to 2 hours, held on school premises. Each group includes 8 to 10 adolescents. The sessions are facilitated by two psychologists and/or senior psychology students who have been specifically trained to deliver the intervention. The sessions focus on developing various emotional regulation skills, which participants are encouraged to practice both during and between sessions. Some of the key skills covered include Mindfulness, Wise Mind, and Problem-Solving, among others. |
|
No Intervention: Waitlist Control Group
Participants in this group will not receive the intervention initially and will be placed on a waitlist.
They will receive the same emotional regulation skills training (ERST) intervention after the experimental group has completed the program.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline in Emotional Dysregulation Over Time Compared to the Control Group
Time Frame: 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).
|
Day 0 = during enrollment, Month 2 = immediately after the experimental group completes the intervention, and Month 3 = three months later for follow-up
|
|
Change from Baseline in Psychological Functioning screening Over Time Compared to the Control Group
Time Frame: 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). |
Day 0 = during enrollment, Month 2 = immediately after the experimental group completes the intervention, and Month 3 = three months later for follow-up
|
|
Change from Baseline in Anxiety Symptoms Over Time Compared to the Control Group
Time Frame: 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). |
Day 0 = during enrollment, Month 2 = immediately after the experimental group completes the intervention, and Month 3 = three months later for follow-up
|
|
Change from Baseline in Depressive Symptoms Over Time Compared to the Control Group
Time Frame: 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). |
Day 0 = during enrollment, Month 2 = immediately after the experimental group completes the intervention, and Month 3 = three months later for follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline in Clinical Symptoms Over Time Compared to the Control Group, with Masking in the Evaluation Process
Time Frame: 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.
|
Day 0 = during enrollment, Month 2 = immediately after the experimental group completes the intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FONDECYT INI 11230147
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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