Emotional DysregulationEmoTIConSNCT04349709
Emotional Regulation in Teens: Improvement of Constructive Skills
A study testing Brief school-based DBT-A in people with Emotional Dysregulation, run by IRCCS Centro San Giovanni di Dio Fatebenefratelli at 1 site in Italy.
Trial summary
This is a prospective randomized study with twofold aim. The first aim is to evaluate the impact of a school-based intervention focused on emotional regulation skills according to Dialectical Behavior Therapy for Adolescents. Read more about this study
- Who is it for?
- Ages 16 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Emotional Dysregulation
- What is being tested?
- Brief school-based DBT-A
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 462 participants
- Where
- 1 siteItaly
- Study dates
- 25 Nov 2019to 31 Dec 2023
- 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 16 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Students attending the third year of high school (10th academic grade)
- Signed consent form
Who cannot join
- Mental retardation
- Asperger syndrome
- Autism spectrum disorders
Trial locations and contacts
1 site in 1 country.
Italy1 site
IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli
Brescia, 25125
About this study
Official title: Emotional Dysregulation in Adolescents: Clinical and Biological Correlates.
This is a prospective randomized study with twofold aim. The first aim is to evaluate the impact of a school-based intervention focused on emotional regulation skills according to Dialectical Behavior Therapy for Adolescents. To this purpose, a sample of students attending the third year of high school (10th grade; 16-19 years) will be recruited, and the interventions will be delivered to the class of students during school-time. The outcomes will be evaluated (post-intervention, 3 and 6-months follow-up) in term of frequency of dysfunctional behaviours, use of emotional regulation skills, and psychological wellbeing. The study is also aimed to identify clinical and biological markers associated to ED in adolescents. To this purpose, youth psychiatric outpatients (16-19 years) will be recruited and compared to the participants of the community sample. All the participants will be evaluated through a comprehensive assessment including both clinical variables and biological variables. Biological evaluations will be conducted to measure cortisol levels during the day (awakening, noon and evening) and the inflammatory profiles
Read the detailed description
Emotional dysregulation (ED) is a multidimensional construct including lack of awareness and clarity about experienced emotions, nonacceptance of emotional distress, impulsivity, inability to pursue goals when emotionally distressed, and lack of regulatory strategies (Gratz and Roemer, 2004).
The background of the present study is threefold:
- Adolescence is a heightened risk period for the onset of a wide range of mental disorder. Targeting emotional dysregulation (ED) in adolescence could be particularly relevant, indeed, there is a strong association between ED and dysfunctional behaviours such as substance-related problems (Barahmand et al., 2016; Simons et al., 2017), suicidal ideation (Miller et al., 2017; Rajappa et al., 2012), and self-harm behaviors (Peh et al., 2017).
- Emotion regulation is a modifiable skill, and school-based prevention programs could be effective for the development of socio-emotional skills, and the improvement of psychological well-being (Taylor et al., 2017).
- Stressful experiences, especially those occurring early in life, enhance the vulnerability for a spectrum of psychiatric disorders, via targeting both the Hypothalamic-Pituitary-Adrenal (HPA) axis system and the immune/inflammatory system (Lopizzo et al., 2015; 2017). Moreover, there is evidence that individuals exposed to early traumatic experiences exhibit difficulties in regulating their emotional responses (Jennissen et al., 2016). For this reasons, longitudinal studies focused on the association between HPA axis activity and the later development of psychopathology are of great interest because they may be helpful to identify possible risk factors for mental illness. However, only few studies analyzed the neurobiological correlated of ED in adolescents (Goodyer et al., 2000; Halligan et al., 2007).
The main aim of the present study aims to evaluate the impact of an intervention based on Dialectical Behavior Therapy for Adolescents (DBT-A) (Rathus \& Miller, 2015, Mazza, et al, 2016) that will be delivered to the class of students during school-time. A total of 426 students attending the third year of high school (10th grade; 16-19 years) will be recruited. In order to optimize the representativeness of the sample, different type of school (i.e. professional institute; technical institute; arts, scientific and classical high schools) will be invited to participate to the study. Moreover, the randomization will be carried out in each school in order to control potential confounding variables associated to a specific type of school. Outcome will be assessed post-intervention, 3 and 6-month follow-up.
The second aim of the present study is to identify clinical and biological markers associated to ED. To this purpose, a clinical sample of youth outpatients (16-19 years) with mental disorders will be recruited and will be compared to the students of the community sample. All the participants will be evaluated through a comprehensive assessment including both clinical variables and biological variables. Clinical assessment will cover different domains: sociodemographic data, emotional dysregulation, psychopathological symptoms, social functioning, childhood trauma, stressful life events during previous year. Biological evaluations will be conducted to measure cortisol levels during the day (awakening, noon and evening) and the inflammatory profiles. Data about biological parameters will permit to investigate whether alterations in biological features related to stress response and inflammation can underlie ED and the vulnerability for psychopathology. Moreover, the same set of biomarkers will be evaluated at the end of the intervention in order to evaluate whether clinical improvements can occur via le modulation of these pathways.
- Conditions
- Emotional Dysregulation
- Being tested
- Brief school-based DBT-A
- Keywords
- Adolescence, Dialectical behavior therapy, stress, school-based intervention, psychoeducation, cortisol, inflammation
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief school-based DBT-ABehavioural
The intervention is inspired to Dialectical Behavior Therapy for Adolescents (DBT-A) (Rathus \& Miller, 2015, Mazza et al, 2016; Cappelluccio, 2019). It consists in four monthly 2-hour sessions (for a total of 8 hours) scheduled during school-time. All the sessions are conducted by two psychotherapists trained about DBT. During the sessions, the model of emotions is described through a role-play between conductors. Subsequently, teens are trained about main emotional regulation skills. Moreover, basic elements of distress tolerance, mindfulness and interpersonal efficacy are introduced too.
| Study group | Role | What they receive |
|---|---|---|
| Brief school-based DBT-A | Experimental | The students of classes randomized to experimental group receive the brief school-based DBT-A.. Receives: Behavioral: Brief school-based DBT-A |
| control group | No intervention | The students of classes randomized to control group continue their school activity as routine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in dysfunctional/impulsive behaviours measured by Checklist for dysfunctional, impulsive behaviours.
The Checklist for dysfunctional, impulsive behaviors is an had-hoc created instrument to measure the dysfunctional/impulsive behaviours (e.g. binge drinking, substance use, unprotected sex, self-harm, etc). For each behaviour, participants are asked to fill the frequency of dysfunctional/impulsive over the previous month
Measured: 5, 8, 11 months
Change in emotional regulation skills measured by the DBT-Ways of Coping Checklist (DBT-WCCL).
The DBT-WCCL is a 59-item self-report instrument measuring the frequency of DBT skills use (DBT Skills Subscale, 38 items) and dysfunctional non-DBT coping strategies (Dysfunctional Coping Subscale, 21 items) over the previous month.
Measured: 5, 8, 11 months
Secondary outcomes (3)
Change in problem-solving strategies as detected by change in mean scores on Social Problem-Solving Inventory-Revised Short Form (SPSI-R:SF) (Maydeu-Olivares & D'Zurilla 1996)
The SPSI-R:SF is a 25-item self-report questionnaire, with five subscales that assess functional and dysfunctional cognitive and emotional orientations towards solving life problems. The subscales are: positive problem orientation (PPO), negative problem orientation (NPO), rational problem solving (RPS), impulsivity-carelessness style (ICS), avoidant style (AS). Higher scores on the NPO, ICS and AS reflect a more maladaptive approach to problem solving; whereas higher scores on the PPO and RPS indicate more adaptive problem solving (D'Zurilla et al., 2002).
Measured: 5, 8, 11 months
Change in depressive symptoms as detected by change in mean Patient Health Questionnaire PHQ-9 global score.
The PHQ is a 9-item self-report questionnaire that cover depressive symptoms criteria of the 9 DSM-IV. A global score is computed as the sum of the nine item and it can range from 0 to 27. Different level of severity of depression can be distinguished according to cut-off (Kroenke et al., 2001).
Measured: 5, 8, 11 months
Change in emotional dysregulation as detected by change in mean scores on the Difficulties in Emotion Regulation Scale (DERS) (Gratz and Roemer, 2004).
The DERS is a 36-item self-report questionnaire with six subscales that assess dimensions of emotional dysregulation: (1) Non-acceptance of emotional responses (6 items); (2) Difficulties engaging in goal-directed behaviour (5 items); (3) Impulse control difficulties (6 items); (4) Lack of emotional awareness (6 items); (5) Limited access to emotion regulation strategies (8 items); (6) Lack of emotional clarity (5 items).
Measured: 5, 8, 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start25 Nov 2019
- Primary completion30 Oct 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Emotional DysregulationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 462 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Centro San Giovanni di Dio Fatebenefratelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Pedrini, IRCCS Centro San Giovanni di Dio Fatebenefratelli
- Investigators
- Laura Pedrini, PhD, Principal investigator, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04349709
- Sponsor's protocol ID
- GR-2018-12366754
- Acronym
- EmoTIConS
- Status last verified
- Mar 2024
- First submitted
- 10 Apr 2020
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mazza et al, DBT Skills in Schools (DBT STEPS-A). Guilford Publications; 2016
Rathus&Miller, DBT Skills Manual for Adolescents, Guildford Press; 2015
Taylor RD, Oberle E, Durlak JA, Weissberg RP. Promoting Positive Youth Development Through School-Based Social and Emotional Learning Interventions: A Meta-Analysis of Follow-Up Effects. Child Dev. 2017 Jul;88(4):1156-1171. doi: 10.1111/cdev.12864.
PubMed 28685826Beauchaine TP. Future Directions in Emotion Dysregulation and Youth Psychopathology. J Clin Child Adolesc Psychol. 2015;44(5):875-96. doi: 10.1080/15374416.2015.1038827. Epub 2015 May 27.
PubMed 26016727Pedrini L, Rossi R, Magni LR, Lanfredi M, Meloni S, Ferrari C, Macis A, Lopizzo N, Zonca V, Cattaneo A. Emotional Regulation in Teens and Improvement of Constructive Skills (EmoTIConS): study protocol for a randomized controlled trial. Trials. 2021 Dec 14;22(1):920. doi: 10.1186/s13063-021-05886-2.
PubMed 34906222
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotional Dysregulation in Adolescents: Clinical and Biological Correlates.
- ClinicalTrials.gov ID
- NCT04349709
- Acronym / sponsor ID
- EmoTIConS / GR-2018-12366754
- Conditions
- Emotional Dysregulation
- Keywords
- Adolescence, Dialectical behavior therapy, stress, school-based intervention, psychoeducation, cortisol, inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 462 participants (actual)
- Lead sponsor
- IRCCS Centro San Giovanni di Dio FatebenefratelliUniversity, hospital or other
- Study start
- 25 Nov 2019 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 16 Apr 2020 (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.
This is a prospective randomized study with twofold aim. The first aim is to evaluate the impact of a school-based intervention focused on emotional regulation skills according to Dialectical Behavior Therapy for Adolescents. To this purpose, a sample of students attending the third year of high school (10th grade; 16-19 years) will be recruited, and the interventions will be delivered to the class of students during school-time. The outcomes will be evaluated (post-intervention, 3 and 6-months follow-up) in term of frequency of dysfunctional behaviours, use of emotional regulation skills, and psychological wellbeing. The study is also aimed to identify clinical and biological markers associated to ED in adolescents. To this purpose, youth psychiatric outpatients (16-19 years) will be recruited and compared to the participants of the community sample. All the participants will be evaluated through a comprehensive assessment including both clinical variables and biological variables. Biological evaluations will be conducted to measure cortisol levels during the day (awakening, noon and evening) and the inflammatory profiles
Detailed description
Emotional dysregulation (ED) is a multidimensional construct including lack of awareness and clarity about experienced emotions, nonacceptance of emotional distress, impulsivity, inability to pursue goals when emotionally distressed, and lack of regulatory strategies (Gratz and Roemer, 2004).
The background of the present study is threefold:
- Adolescence is a heightened risk period for the onset of a wide range of mental disorder. Targeting emotional dysregulation (ED) in adolescence could be particularly relevant, indeed, there is a strong association between ED and dysfunctional behaviours such as substance-related problems (Barahmand et al., 2016; Simons et al., 2017), suicidal ideation (Miller et al., 2017; Rajappa et al., 2012), and self-harm behaviors (Peh et al., 2017).
- Emotion regulation is a modifiable skill, and school-based prevention programs could be effective for the development of socio-emotional skills, and the improvement of psychological well-being (Taylor et al., 2017).
- Stressful experiences, especially those occurring early in life, enhance the vulnerability for a spectrum of psychiatric disorders, via targeting both the Hypothalamic-Pituitary-Adrenal (HPA) axis system and the immune/inflammatory system (Lopizzo et al., 2015; 2017). Moreover, there is evidence that individuals exposed to early traumatic experiences exhibit difficulties in regulating their emotional responses (Jennissen et al., 2016). For this reasons, longitudinal studies focused on the association between HPA axis activity and the later development of psychopathology are of great interest because they may be helpful to identify possible risk factors for mental illness. However, only few studies analyzed the neurobiological correlated of ED in adolescents (Goodyer et al., 2000; Halligan et al., 2007).
The main aim of the present study aims to evaluate the impact of an intervention based on Dialectical Behavior Therapy for Adolescents (DBT-A) (Rathus \& Miller, 2015, Mazza, et al, 2016) that will be delivered to the class of students during school-time. A total of 426 students attending the third year of high school (10th grade; 16-19 years) will be recruited. In order to optimize the representativeness of the sample, different type of school (i.e. professional institute; technical institute; arts, scientific and classical high schools) will be invited to participate to the study. Moreover, the randomization will be carried out in each school in order to control potential confounding variables associated to a specific type of school. Outcome will be assessed post-intervention, 3 and 6-month follow-up.
The second aim of the present study is to identify clinical and biological markers associated to ED. To this purpose, a clinical sample of youth outpatients (16-19 years) with mental disorders will be recruited and will be compared to the students of the community sample. All the participants will be evaluated through a comprehensive assessment including both clinical variables and biological variables. Clinical assessment will cover different domains: sociodemographic data, emotional dysregulation, psychopathological symptoms, social functioning, childhood trauma, stressful life events during previous year. Biological evaluations will be conducted to measure cortisol levels during the day (awakening, noon and evening) and the inflammatory profiles. Data about biological parameters will permit to investigate whether alterations in biological features related to stress response and inflammation can underlie ED and the vulnerability for psychopathology. Moreover, the same set of biomarkers will be evaluated at the end of the intervention in order to evaluate whether clinical improvements can occur via le modulation of these pathways.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief school-based DBT-A | Experimental | Behavioral: Brief school-based DBT-AThe students of classes randomized to experimental group receive the brief school-based DBT-A.. |
| control group | No intervention | –The students of classes randomized to control group continue their school activity as routine. |
Who may qualify
- Ages
- 16 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Students attending the third year of high school (10th academic grade)
- Signed consent form
Key exclusion criteria (3 listed)
- Mental retardation
- Asperger syndrome
- Autism spectrum disorders
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 |
|---|---|---|
| Brief school-based DBT-AThe intervention is inspired to Dialectical Behavior Therapy for Adolescents (DBT-A) (Rathus \& Miller, 2015, Mazza et al, 2016; Cappelluccio, 2019). It consists in four monthly 2-hour sessions (for a total of 8 hours) scheduled during school-time. All the sessions are conducted by two psychotherapists trained about DBT. During the sessions, the model of emotions is described through a role-play between conductors. Subsequently, teens are trained about main emotional regulation skills. Moreover, basic elements of distress tolerance, mindfulness and interpersonal efficacy are introduced too. | Behavioural | Brief school-based DBT-A |
Primary outcome
Change in dysfunctional/impulsive behaviours measured by Checklist for dysfunctional, impulsive behaviours.
Time frame: 5, 8, 11 months
The Checklist for dysfunctional, impulsive behaviors is an had-hoc created instrument to measure the dysfunctional/impulsive behaviours (e.g. binge drinking, substance use, unprotected sex, self-harm, etc). For each behaviour, participants are asked to fill the frequency of dysfunctional/impulsive over the previous month
Change in emotional regulation skills measured by the DBT-Ways of Coping Checklist (DBT-WCCL).
Time frame: 5, 8, 11 months
The DBT-WCCL is a 59-item self-report instrument measuring the frequency of DBT skills use (DBT Skills Subscale, 38 items) and dysfunctional non-DBT coping strategies (Dysfunctional Coping Subscale, 21 items) over the previous month.
3 secondary outcomes
Change in problem-solving strategies as detected by change in mean scores on Social Problem-Solving Inventory-Revised Short Form (SPSI-R:SF) (Maydeu-Olivares & D'Zurilla 1996)
Time frame: 5, 8, 11 months
Change in depressive symptoms as detected by change in mean Patient Health Questionnaire PHQ-9 global score.
Time frame: 5, 8, 11 months
Change in emotional dysregulation as detected by change in mean scores on the Difficulties in Emotion Regulation Scale (DERS) (Gratz and Roemer, 2004).
Time frame: 5, 8, 11 months
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 7 Mar 2024.
- BackgroundMazza et al, DBT Skills in Schools (DBT STEPS-A). Guilford Publications; 2016
- BackgroundRathus&Miller, DBT Skills Manual for Adolescents, Guildford Press; 2015
- Background: PubMed 28685826Taylor RD, Oberle E, Durlak JA, Weissberg RP. Promoting Positive Youth Development Through School-Based Social and Emotional Learning Interventions: A Meta-Analysis of Follow-Up Effects. Child Dev. 2017 Jul;88(4):1156-1171. doi: 10.1111/cdev.12864.
- Background: PubMed 26016727Beauchaine TP. Future Directions in Emotion Dysregulation and Youth Psychopathology. J Clin Child Adolesc Psychol. 2015;44(5):875-96. doi: 10.1080/15374416.2015.1038827. Epub 2015 May 27.
- Derived from this study: PubMed 34906222Pedrini L, Rossi R, Magni LR, Lanfredi M, Meloni S, Ferrari C, Macis A, Lopizzo N, Zonca V, Cattaneo A. Emotional Regulation in Teens and Improvement of Constructive Skills (EmoTIConS): study protocol for a randomized controlled trial. Trials. 2021 Dec 14;22(1):920. doi: 10.1186/s13063-021-05886-2.
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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.
Laura Pedrini, PhD principal investigator
IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief school-based DBT-A in people with Emotional Dysregulation, run by IRCCS Centro San Giovanni di Dio Fatebenefratelli at 1 site in Italy.
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 2 inclusion and 3 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 7 Mar 2024. 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 Italy. 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 in dysfunctional/impulsive behaviours measured by Checklist for dysfunctional, impulsive behaviours. (time frame: 5, 8, 11 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04349709, which also lists 5 linked publications.
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 7 Mar 2024.