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Completed

NCT Number: NCT03900533

Emotion Regulation Group Skills Training for Adolescents and Parents

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.

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Key information

Conditions

Behavioral Symptoms Behavior Emotional Instability

Age range

14 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Region Östergötland BUP-kliniken

Linköping, 581 85, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adjunctive group emotion regulation skills training

Behavioral

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

Behavioral

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Region Östergötland

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Apr 3, 2019
Registry last updated
Oct 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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