NCT03900533

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
119

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

April 2, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 3, 2019

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 4, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2023

Completed
Last Updated

October 29, 2024

Status Verified

October 1, 2024

Enrollment Period

4.4 years

First QC Date

March 29, 2019

Last Update Submit

October 25, 2024

Conditions

Keywords

child psychiatryemotion regulation skills training

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Beck's Anxiety Inventory (BAI)

    Change from baseline at 7 weeks and at 3 months

  • Montgomery Åsberg Depression Rating Scale, self-report version (MADRS-S).

    Change from baseline at 7 weeks and at 3 months

  • Global Assessment Scale for Children (C-GAS)

    Change from baseline at 7 weeks and at 3 months

  • Brunnsviken Brief Quality of Life (BBQ)

    Change from baseline at 7 weeks and at 3 months

  • Toronto Alexithymia Scale (TAS-20)

    Change from baseline at 7 weeks and at 3 months

  • +1 more secondary outcomes

Study Arms (2)

Adjunctive group emotion regulation skills training

EXPERIMENTAL

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

Treatment as usual (TAU)

ACTIVE COMPARATOR

Participants will receive treatment as usual for 7 weeks as provided by the child- and adolescent psychiatric clinic

Behavioral: Treatment as usual

Interventions

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

Adjunctive group emotion regulation skills training

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

Treatment as usual (TAU)

Eligibility Criteria

Age14 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Region Östergötland BUP-kliniken

Linköping, 581 85, Sweden

Location

MeSH Terms

Conditions

Behavioral Symptoms

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Maria A Zetterqvist, PhD

    Region Ostergotland/Linköping universitet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 29, 2019

First Posted

April 3, 2019

Study Start

April 2, 2019

Primary Completion

September 4, 2023

Study Completion

September 4, 2023

Last Updated

October 29, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations