Strengthening Emotional Regulation: a Group Intervention with Adolescents

NCT ID: NCT06878521

Last Updated: 2025-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-12

Study Completion Date

2025-12-19

Brief Summary

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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

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Conditions

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Emotional Regulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Emotional regulation skills training Group

Participants in this group will receive the emotional regulation skills training (ERST) intervention.

Group Type EXPERIMENTAL

Emotional Regulation Skills

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Emotional Regulation Skills

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Agencia Nacional de Investigación y Desarrollo

OTHER

Sponsor Role collaborator

Lorena Wenger Amengual

OTHER

Sponsor Role lead

Responsible Party

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Lorena Wenger Amengual

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Universidad de La Frontera

Temuco, , Chile

Site Status RECRUITING

Countries

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Chile

Facility Contacts

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Lorena Wenger, Dra.

Role: primary

+56 45 2592188

Other Identifiers

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FONDECYT INI 11230147

Identifier Type: -

Identifier Source: org_study_id

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