Emotion Regulation Group Skills Training for Adolescents and Parents

Sponsor
Region Östergötland (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03900533
Collaborator
(none)
105
1
2
38
2.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Adjunctive group emotion regulation skills training
  • Behavioral: Treatment as usual
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
105 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Emotion Regulation Group Skills Training for Adolescents and Parents: A Randomized Controlled Study in a Clinical Setting
Actual Study Start Date :
Apr 2, 2019
Anticipated Primary Completion Date :
Apr 1, 2022
Anticipated Study Completion Date :
Jun 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Difficulties with Emotion Regulation Scale (DERS) [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).

  2. Toronto Alexithymia Scale (TAS-20) [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.

  3. Levels of Emotional Awareness (LEAS-C) [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 Outcome Measures

  1. Beck's Anxiety Inventory (BAI) [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). [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) [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) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
14 Years to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Region Östergötland BUP-kliniken Linköping Sweden 581 85

Sponsors and Collaborators

  • Region Östergötland

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Maria Zetterqvist, Principal Investigator, Region Östergötland
ClinicalTrials.gov Identifier:
NCT03900533
Other Study ID Numbers:
  • 2015/264-31
First Posted:
Apr 3, 2019
Last Update Posted:
Jan 5, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Maria Zetterqvist, Principal Investigator, Region Östergötland
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 5, 2022