Emotion Regulation Group Skills Training for Adolescents and Parents

Overview

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.

Full Title of Study: “Emotion Regulation Group Skills Training for Adolescents and Parents: A Randomized Controlled Study in a Clinical Setting”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2023

Interventions

  • 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
  • Behavioral: Treatment as usual
    • Treatment as usual at the child- and adolescent psychiatric clinic is delivered during 7 weeks

Arms, Groups and Cohorts

  • 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
  • Active Comparator: Treatment as usual (TAU)
    • Participants will receive treatment as usual for 7 weeks as provided by the child- and adolescent psychiatric clinic

Clinical Trial Outcome Measures

Primary Measures

  • 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).
  • Toronto Alexithymia Scale (TAS-20)
    • Time Frame: Change from baseline at 7 weeks and at 3 months
    • 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)
    • Time Frame: Change from baseline at 7 weeks and at 3 months
    • 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 Measures

  • Beck’s Anxiety Inventory (BAI)
    • Time Frame: Change from baseline at 7 weeks and at 3 months
    • 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).
    • Time Frame: Change from baseline at 7 weeks and at 3 months
    • 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)
    • Time Frame: Change from baseline at 7 weeks and at 3 months
    • 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)
    • Time Frame: Change from baseline at 7 weeks and at 3 months
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 14 Years

Maximum Age: 17 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Region Östergötland
  • Provider of Information About this Clinical Study
    • Principal Investigator: Maria Zetterqvist, Principal Investigator – Region Östergötland
  • Overall Official(s)
    • Maria A Zetterqvist, PhD, Principal Investigator, Region Ostergotland/Linköping universitet
  • Overall Contact(s)
    • Maria A Zetterqvist, PhD, +46101034339, maria.zetterqvist@liu.se

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