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Trial record 6 of 1519 for:    child psychiatry

Emotion Regulation Group Skills Training for Adolescents and Parents

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ClinicalTrials.gov Identifier: NCT03900533
Recruitment Status : Recruiting
First Posted : April 3, 2019
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
Maria Zetterqvist, Region Östergötland

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 Symptoms Emotional Instability Behavioral: Adjunctive group emotion regulation skills training Behavioral: Treatment as usual Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 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
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020

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




Primary Outcome Measures :
  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).

  2. 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.

  3. 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 Outcome Measures :
  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.



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Ages Eligible for Study:   14 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03900533


Contacts
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Contact: Maria A Zetterqvist, PhD +46101034339 ext +46101034339 maria.zetterqvist@liu.se
Contact: Kristina Holmqvist Larsson +46101059675 kristina.holmqvist.larsson@liu.se

Locations
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Sweden
Region Östergötland BUP-kliniken Recruiting
Linköping, Sweden, 581 85
Contact: Maria A Zetterqvist, PhD    +46101034339 ext +46101034339    maria.zetterqvist@liu.se   
Contact: Kristina Holmqvist Larsson    +46101059675    kristina.holmqvist.larsson@liu.se   
Sponsors and Collaborators
Region Östergötland
Investigators
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Principal Investigator: Maria A Zetterqvist, PhD Region Ostergotland/Linköping universitet

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Responsible Party: Maria Zetterqvist, Principal Investigator, Region Östergötland
ClinicalTrials.gov Identifier: NCT03900533     History of Changes
Other Study ID Numbers: 2015/264-31
First Posted: April 3, 2019    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maria Zetterqvist, Region Östergötland:
child psychiatry
emotion regulation skills training
Additional relevant MeSH terms:
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Behavioral Symptoms