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Completed

NCT Number: NCT06878521

Strengthening Emotional Regulation: a Group Intervention With Adolescents

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.

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Key information

Conditions

Emotional Regulation Behavior Self-Control Social Behavior

Age range

14 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad de La Frontera

Temuco, Chile

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Emotional Regulation Skills

Other

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.

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Lorena Wenger Amengual

Other

Collaborators

  • Agencia Nacional de Investigación y Desarrollo

Registry information

Official study 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]

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 17, 2025
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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