Emotional RegulationNCT06878521
Strengthening Emotional Regulation: a Group Intervention With Adolescents
A study testing Emotional Regulation Skills in people with Emotional Regulation, run by Lorena Wenger Amengual at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 16 years
- Conditions the study is for
- Emotional Regulation
- What is being tested?
- Emotional Regulation Skills
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteChile
- Study dates
- 12 Jul 2024to 9 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Adolescents who are regularly receiving psychological treatment
Trial locations and contacts
1 site in 1 country.
About this study
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]
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.
Read more
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.
- Conditions
- Emotional Regulation
- Being tested
- Emotional Regulation Skills
- Keywords
- Adolescents, Emotional regulation, Transdiagnostic, Transdiagnostic intervention, Group intervention, Emotion Regulation Skills Training, School-based intervention
- Medical subject headings
- Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotional Regulation SkillsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Emotional regulation skills training Group | Experimental | Participants in this group will receive the emotional regulation skills training (ERST) intervention. Receives: Other: Emotional Regulation Skills |
| Waitlist Control Group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Emotional Dysregulation Over Time Compared to the Control Group
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).
Measured: 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
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).
Measured: 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
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).
Measured: 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
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).
Measured: 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 (1)
Change from Baseline in Clinical Symptoms Over Time Compared to the Control Group, with Masking in the Evaluation Process
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.
Measured: Day 0 = during enrollment, Month 2 = immediately after the experimental group completes the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start12 Jul 2024
- Primary completion9 Dec 2025
- Study completion9 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional RegulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lorena Wenger Amengual
- Sponsor type
- University, hospital or other
- Collaborators
- Agencia Nacional de Investigación y Desarrollo
- Responsible party
- Sponsor-investigator, Lorena Wenger Amengual, Universidad de La Frontera
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06878521
- Sponsor's protocol ID
- FONDECYT INI 11230147
- Status last verified
- Mar 2026
- First submitted
- 29 Jan 2025
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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]
- ClinicalTrials.gov ID
- NCT06878521
- Acronym / sponsor ID
- FONDECYT INI 11230147
- Conditions
- Emotional Regulation
- Keywords
- Adolescents, Emotional regulation, Transdiagnostic, Transdiagnostic intervention, Group intervention, Emotion Regulation Skills Training, School-based intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Lorena Wenger AmengualUniversity, hospital or other
- Collaborators
- Agencia Nacional de Investigación y Desarrollo
- Study start
- 12 Jul 2024 (actual)
- Primary completion
- 9 Dec 2025 (actual)
- Study completion
- 9 Dec 2025 (actual)
- First posted
- 17 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Emotional regulation skills training Group | Experimental | Other: Emotional Regulation SkillsParticipants in this group will receive the emotional regulation skills training (ERST) intervention. |
| Waitlist Control Group | No intervention | –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. |
Who may qualify
- Ages
- 14 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Adolescents who are regularly receiving psychological treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emotional Regulation SkillsThis 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. | Other | Emotional regulation skills training Group |
Primary outcome
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).
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).
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).
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).
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotional Regulation Skills in people with Emotional Regulation, run by Lorena Wenger Amengual at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.