Emotion Regulation Group Skills Training for Adolescents and Parents

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.

Study Overview

• Status: Completed
• Conditions: Behavioral Symptoms; Emotional Instability
• Intervention / Treatment: Behavioral: Adjunctive group emotion regulation skills training; Behavioral: Treatment as usual

• Study Type: Interventional
• Enrollment (Actual): 119
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Linköping, Sweden, 581 85
    • Region Östergötland BUP-kliniken

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adjunctive group emotion regulation skills training; 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	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
Active Comparator: Treatment as usual (TAU); Participants will receive treatment as usual for 7 weeks as provided by the child- and adolescent psychiatric clinic	Behavioral: Treatment as usual; Treatment as usual at the child- and adolescent psychiatric clinic is delivered during 7 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Region Östergötland
• Investigators: Principal Investigator: Maria A Zetterqvist, PhD, Region Ostergotland/Linköping universitet

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2019
• Primary Completion (Actual): September 4, 2023
• Study Completion (Actual): September 4, 2023

Study Registration Dates

• First Submitted: March 29, 2019
• First Submitted That Met QC Criteria: March 31, 2019
• First Posted (Actual): April 3, 2019

Study Record Updates

• Last Update Posted (Actual): October 29, 2024
• Last Update Submitted That Met QC Criteria: October 25, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: child psychiatry; emotion regulation skills training
• Additional Relevant MeSH Terms: Behavioral Symptoms
• Other Study ID Numbers: 2015/264-31

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No