Behavioral SymptomsNCT03900533
Emotion Regulation Group Skills Training for Adolescents and Parents
A study testing Adjunctive group emotion regulation skills training and Treatment as usual in people with Behavioral Symptoms and Emotional Instability, run by Region Östergötland at 1 site in Sweden.
Trial summary
To evaluate if emotion regulation group therapy skills training for adolescents and parents is an efficacious treatment when delivered as adjunctive to treatment as usual compared to a control group consisting of treatment as usual. Read more about this study
- Who is it for?
- Ages 14 to 17 years
- Conditions the study is for
- Behavioral Symptoms, Emotional Instability
- What is being tested?
- Adjunctive group emotion regulation skills training and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteSweden
- Study dates
- 2 Apr 2019to 4 Sep 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 14 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Being enrolled as a patient at the child- and adolescent psychiatric clinic in Linköping
- Having an adult participant joining the skills training
- Being between the ages of 14-17 years
- Having sufficient knowledge of the Swedish language
Who cannot join
- Clinical diagnosis of schizophrenia
- Clinical diagnosis of psychosis
- Clinical diagnosis of severe anorexia nervosa
- Clinical diagnosis of severe autism spectrum disorder
- Having a cognitive disability
- Having an ongoing drug or alcohol abuse
- Clinical diagnosis of bipolar disorder
- Insufficient knowledge of the Swedish language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Emotion Regulation Group Skills Training for Adolescents and Parents: A Randomized Controlled Study in a Clinical Setting
To evaluate if emotion regulation group therapy skills training for adolescents and parents is an efficacious treatment when delivered as adjunctive to treatment as usual compared to a control group consisting of treatment as usual.
- Conditions
- Behavioral Symptoms, Emotional Instability
- Being tested
- Adjunctive group emotion regulation skills training, Treatment as usual
- Keywords
- child psychiatry, emotion regulation skills training
- Medical subject headings
- Behavioral Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjunctive group emotion regulation skills trainingBehavioural
The adjunctive emotion regulation skills training is delivered in a group format once a week during 7 weeks to adolescents and parents jointly together with treatment as usual
Treatment as usualBehavioural
Treatment as usual at the child- and adolescent psychiatric clinic is delivered during 7 weeks
| Study group | Role | What they receive |
|---|---|---|
| Adjunctive group emotion regulation skills training | Experimental | Participants will receive a 7 week group emotion regulation skills training together with parents adjacent to treatment as usual provided by the child- and adolescent psychiatric clinic Receives: Behavioral: Adjunctive group emotion regulation skills training |
| Treatment as usual (TAU) | Active comparator | Participants will receive treatment as usual for 7 weeks as provided by the child- and adolescent psychiatric clinic Receives: Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difficulties with Emotion Regulation Scale (DERS)
Difficulties with Emotion Regulation Scale measures difficulties with emotion regulation. It contains a total of 36 items that are rated on a Likert scale between 1-5. Total score ranges between 36-180 with higher scores indicating more difficulties with emotion regulation. The scale has 6 subscales: nonacceptance (ranging from 6-30); goals (ranging from 5-25); impulse (ranging from 6-30); awareness (ranging from 6-30); strategies (ranging from 8-40) and clarity (ranging from 5-25).
Measured: Change from baseline at 7 weeks and at 3 months
Secondary outcomes (6)
Beck's Anxiety Inventory (BAI)
Beck's Anxiety Inventory measures symptoms of anxiety with 21 items rated on a four-graded scale (0-3). Total scores range from 0-63. Higher scores indicate higher levels of anxiety.
Measured: Change from baseline at 7 weeks and at 3 months
Montgomery Åsberg Depression Rating Scale, self-report version (MADRS-S).
Montgomery Åsberg Depression Rating Scale measures symptoms of depression. Its main purpose is to monitor the development of symptoms during treatment. The scale consists of 9 items, which are graded from zero to six. Total scores range from 0-54. Higher scores indicate higher level of depression symptoms.
Measured: Change from baseline at 7 weeks and at 3 months
Global Assessment Scale for Children (C-GAS)
The Global Assessment Scale for Children measures global functioning on a scale that ranges from 0 to 100 with higher scores indicating higher global functioning.
Measured: Change from baseline at 7 weeks and at 3 months
Brunnsviken Brief Quality of Life (BBQ)
Brunnsviken Brief Quality of Life measures quality of Life in a total of 12 items (6 different areas of life). Satisfaction and how important the different areas of life are, are rated from 0-4. Total scores range from 0-96 with high scores indicating higher levels of quality of life.
Measured: Change from baseline at 7 weeks and at 3 months
Toronto Alexithymia Scale (TAS-20)
Toronto Alexithymia Scale measures alexithymia. It contains a total of 20 items with 3 subscales (difficulties describing feelings: 7 items ranging from 7-35, difficulties identifying feelings: 5 items ranging from 5-25 and externally oriented thinking: 8 items ranging from 8-40). Total scores range from 20-100 with higher scores indicating higher levels of alexithymia.
Measured: Change from baseline at 7 weeks and at 3 months
Levels of Emotional Awareness (LEAS-C)
Measures awareness of emotions, i.e., the ability to identify and describe own and others' emotions. The children's version used in the present study consists of 12 situations, in which the child is asked to describe which emotions he/she and another person would experience in a given situation. Answers are rated by an external rater on a five-grade scale divided into the three subscales: self, other and total.
Measured: Change from baseline at 7 weeks and at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start2 Apr 2019
- Primary completion4 Sep 2023
- Study completion4 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Behavioral SymptomsStudies 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
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Östergötland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Zetterqvist, Region Östergötland
- Investigators
- Maria A Zetterqvist, PhD, Principal investigator, Region Ostergotland/Linköping universitet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03900533
- Sponsor's protocol ID
- 2015/264-31
- Status last verified
- Oct 2024
- First submitted
- 29 Mar 2019
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Holmqvist Larsson K, Falkenstrom F, Andersson G, Stern H, Bolmgren L, Engstrom T, Kallstrom V, Nilsson M, Pettersson E, Seesing F, Ohman T, Osterman K, Zetterqvist M. Emotion regulation skills training for adolescents and parents in a clinical setting: a randomised controlled trial. Child Adolesc Psychiatry Ment Health. 2026 May 28;20(1):85. doi: 10.1186/s13034-026-01098-1.
PubMed 42210292
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotion Regulation Group Skills Training for Adolescents and Parents: A Randomized Controlled Study in a Clinical Setting
- ClinicalTrials.gov ID
- NCT03900533
- Acronym / sponsor ID
- 2015/264-31
- Conditions
- Behavioral Symptoms, Emotional Instability
- Keywords
- child psychiatry, emotion regulation skills training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Region ÖstergötlandUniversity, hospital or other
- Study start
- 2 Apr 2019 (actual)
- Primary completion
- 4 Sep 2023 (actual)
- Study completion
- 4 Sep 2023 (actual)
- First posted
- 3 Apr 2019 (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.
To evaluate if emotion regulation group therapy skills training for adolescents and parents is an efficacious treatment when delivered as adjunctive to treatment as usual compared to a control group consisting of treatment as usual.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adjunctive group emotion regulation skills training | Experimental | Behavioral: Adjunctive group emotion regulation skills trainingParticipants will receive a 7 week group emotion regulation skills training together with parents adjacent to treatment as usual provided by the child- and adolescent psychiatric clinic |
| Treatment as usual (TAU) | Active comparator | Behavioral: Treatment as usualParticipants will receive treatment as usual for 7 weeks as provided by the child- and adolescent psychiatric clinic |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Being enrolled as a patient at the child- and adolescent psychiatric clinic in Linköping
- Having an adult participant joining the skills training
- Being between the ages of 14-17 years
- Having sufficient knowledge of the Swedish language
Key exclusion criteria (8 listed)
- Clinical diagnosis of schizophrenia
- Clinical diagnosis of psychosis
- Clinical diagnosis of severe anorexia nervosa
- Clinical diagnosis of severe autism spectrum disorder
- Having a cognitive disability
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 |
|---|---|---|
| Adjunctive group emotion regulation skills trainingThe adjunctive emotion regulation skills training is delivered in a group format once a week during 7 weeks to adolescents and parents jointly together with treatment as usual | Behavioural | Adjunctive group emotion regulation skills training |
| Treatment as usualTreatment as usual at the child- and adolescent psychiatric clinic is delivered during 7 weeks | Behavioural | Treatment as usual (TAU) |
Primary outcome
Difficulties with Emotion Regulation Scale (DERS)
Time frame: Change from baseline at 7 weeks and at 3 months
Difficulties with Emotion Regulation Scale measures difficulties with emotion regulation. It contains a total of 36 items that are rated on a Likert scale between 1-5. Total score ranges between 36-180 with higher scores indicating more difficulties with emotion regulation. The scale has 6 subscales: nonacceptance (ranging from 6-30); goals (ranging from 5-25); impulse (ranging from 6-30); awareness (ranging from 6-30); strategies (ranging from 8-40) and clarity (ranging from 5-25).
6 secondary outcomes
Beck's Anxiety Inventory (BAI)
Time frame: Change from baseline at 7 weeks and at 3 months
Montgomery Åsberg Depression Rating Scale, self-report version (MADRS-S).
Time frame: Change from baseline at 7 weeks and at 3 months
Global Assessment Scale for Children (C-GAS)
Time frame: Change from baseline at 7 weeks and at 3 months
Brunnsviken Brief Quality of Life (BBQ)
Time frame: Change from baseline at 7 weeks and at 3 months
Toronto Alexithymia Scale (TAS-20)
Time frame: Change from baseline at 7 weeks and at 3 months
Levels of Emotional Awareness (LEAS-C)
Time frame: Change from baseline at 7 weeks and at 3 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 29 Oct 2024.
- Derived from this study: PubMed 42210292Holmqvist Larsson K, Falkenstrom F, Andersson G, Stern H, Bolmgren L, Engstrom T, Kallstrom V, Nilsson M, Pettersson E, Seesing F, Ohman T, Osterman K, Zetterqvist M. Emotion regulation skills training for adolescents and parents in a clinical setting: a randomised controlled trial. Child Adolesc Psychiatry Ment Health. 2026 May 28;20(1):85. doi: 10.1186/s13034-026-01098-1.
- Individual participant dataSharing planned: No
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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.
Maria A Zetterqvist, PhD principal investigator
Region Ostergotland/Linköping universitet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adjunctive group emotion regulation skills training and Treatment as usual in people with Behavioral Symptoms and Emotional Instability, run by Region Östergötland at 1 site in Sweden.
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 8 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 29 Oct 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 Sweden. 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?
Difficulties with Emotion Regulation Scale (DERS) (time frame: Change from baseline at 7 weeks and at 3 months). 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 NCT03900533, which also lists 1 linked publication.
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 29 Oct 2024.