Emotion Regulation Group Skills Training for Adolescents and Parents

Behavioral Symptoms Clinical Trial

Official title:

Emotion Regulation Group Skills Training for Adolescents and Parents: A Randomized Controlled Study in a Clinical Setting

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03900533
• Other study ID #: 2015/264-31
• Status: Recruiting
• Phase: N/A
• Start date: April 2, 2019
• Est. completion date: September 2023

Study information

• Verified date: July 2023
• Source: Region Östergötland
• Contact: Maria A Zetterqvist, PhD
• Phone: +46101034339
• Email: maria.zetterqvist[@]liu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: September 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Behavioral Symptoms
• Emotional Instability

Intervention

Behavioral:
• Adjunctive group emotion regulation skills training
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 usual
Treatment as usual at the child- and adolescent psychiatric clinic is delivered during 7 weeks

Locations

Country	Name	City	State
Sweden	Region Östergötland BUP-kliniken	Linköping

Sponsors (1)

Lead Sponsor	Collaborator
Region Östergötland

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Change from baseline at 7 weeks and at 3 months
Primary	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.	Change from baseline at 7 weeks and at 3 months
Primary	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.	Change from baseline at 7 weeks and at 3 months
Secondary	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.	Change from baseline at 7 weeks and at 3 months
Secondary	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.	Change from baseline at 7 weeks and at 3 months
Secondary	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.	Change from baseline at 7 weeks and at 3 months
Secondary	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.	Change from baseline at 7 weeks and at 3 months