Back to resultsEmotion Regulation Group Skills Training for Adolescents and Parents
Primary Purpose
Behavioral Symptoms, Emotional Instability
Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Adjunctive group emotion regulation skills training
Treatment as usual
Sponsored by
About this trial
This is an interventional treatment trial for Behavioral Symptoms focused on measuring child psychiatry, emotion regulation skills training
Eligibility Criteria
Inclusion criteria:
- 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
Exclusion criteria:
- 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
Sites / Locations
- Region Östergötland BUP-klinikenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Adjunctive group emotion regulation skills training
Treatment as usual (TAU)
Arm Description
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
Participants will receive treatment as usual for 7 weeks as provided by the child- and adolescent psychiatric clinic
Outcomes
Primary Outcome Measures
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).
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03900533
Brief Title
Emotion Regulation Group Skills Training for Adolescents and Parents
Official Title
Emotion Regulation Group Skills Training for Adolescents and Parents: A Randomized Controlled Study in a Clinical Setting
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 2, 2019 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Region Östergötland
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Behavioral Symptoms, Emotional Instability
Keywords
child psychiatry, emotion regulation skills training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Adjunctive group emotion regulation skills training
Arm Type
Experimental
Arm Description
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
Arm Title
Treatment as usual (TAU)
Arm Type
Active Comparator
Arm Description
Participants will receive treatment as usual for 7 weeks as provided by the child- and adolescent psychiatric clinic
Intervention Type
Behavioral
Intervention Name(s)
Adjunctive group emotion regulation skills training
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Treatment as usual
Intervention Description
Treatment as usual at the child- and adolescent psychiatric clinic is delivered during 7 weeks
Primary Outcome Measure Information:
Title
Difficulties with Emotion Regulation Scale (DERS)
Description
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).
Time Frame
Change from baseline at 7 weeks and at 3 months
Title
Toronto Alexithymia Scale (TAS-20)
Description
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.
Time Frame
Change from baseline at 7 weeks and at 3 months
Title
Levels of Emotional Awareness (LEAS-C)
Description
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.
Time Frame
Change from baseline at 7 weeks and at 3 months
Secondary Outcome Measure Information:
Title
Beck's Anxiety Inventory (BAI)
Description
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.
Time Frame
Change from baseline at 7 weeks and at 3 months
Title
Montgomery Åsberg Depression Rating Scale, self-report version (MADRS-S).
Description
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.
Time Frame
Change from baseline at 7 weeks and at 3 months
Title
Global Assessment Scale for Children (C-GAS)
Description
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.
Time Frame
Change from baseline at 7 weeks and at 3 months
Title
Brunnsviken Brief Quality of Life (BBQ)
Description
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.
Time Frame
Change from baseline at 7 weeks and at 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
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
Exclusion criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria A Zetterqvist, PhD
Phone
+46101034339
Ext
+46101034339
Email
maria.zetterqvist@liu.se
First Name & Middle Initial & Last Name or Official Title & Degree
Kristina Holmqvist Larsson
Phone
+46101059675
Email
kristina.holmqvist.larsson@liu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria A Zetterqvist, PhD
Organizational Affiliation
Region Ostergotland/Linköping universitet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Region Östergötland BUP-kliniken
City
Linköping
ZIP/Postal Code
581 85
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria A Zetterqvist, PhD
Phone
+46101034339
Ext
+46101034339
Email
maria.zetterqvist@liu.se
First Name & Middle Initial & Last Name & Degree
Kristina Holmqvist Larsson
Phone
+46101059675
Email
kristina.holmqvist.larsson@liu.se
12. IPD Sharing Statement
Plan to Share IPD
No
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Emotion Regulation Group Skills Training for Adolescents and Parents
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