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Clinical Trials/NCT06297824
NCT06297824
Completed
Not Applicable

Can a Brief Emotion Regulation Group Therapy Help Adolescents With Deliberate Self-Harm? A Feasibility Study and a Qualitative Interview Study

Karolinska Institutet1 site in 1 country21 target enrollmentOctober 10, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Self-harm
Sponsor
Karolinska Institutet
Enrollment
21
Locations
1
Primary Endpoint
Feasibility measures, attrition
Status
Completed
Last Updated
last year

Overview

Brief Summary

Deliberate self-harm (DSH) is a prevalent behaviour among adolescents but there is no current recommendation for an efficacious treatment. Emotion regulation group therapy (ERGT) is a brief treatment for DSH with a well-documented utility and feasibility in the adult population, and an adapted version for adolescents may provide equal benefits for adolescents, provided adjustments to prevent or decrease social contagion are present.

A quantitative feasibility open trial (N=20) followed up by a qualitative interview study will examine the feasibility, acceptability and preliminary effect of ERGT for adolescents.

Detailed Description

Deliberate self-harm (DSH) is a prevalent behaviour among adolescents but there is no current recommendation for an efficacious treatment. Emotion regulation group therapy (ERGT) is a brief treatment for DSH with a well-documented utility and feasibility in the adult population, and an adapted version for adolescents may provide equal benefits for adolescents, provided adjustments to prevent or decrease social contagion are present. Adaptations to ERGT will result in a 12 session long treatment for adolescents Emotion regulation group therapy for Adolescents (ERGT-A). A parallel parent group focused on strengthening parental skills will be given alongside ERGT-A (5 sessions) Method: A quantitative feasibility open trial (N=20) with pre, post and 1 month follow-up assessments will examine the feasibility, acceptability and preliminary effect of ERGT for adolescents. Feasibility measures include recruitment rate, proportion beginning treatment, attrition, treatment credibility and satisfaction, negative effects, and alliance. Preliminary effects measures include DSH, emotion regulation ability, anxiety and depression. Method: A qualitative interview study. Using thematic analysis to explore participants' experience of ERGT-A and parent group

Registry
clinicaltrials.gov
Start Date
October 10, 2023
End Date
March 10, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hanna Sahlin

Principal Investigator, PhD

Karolinska Institutet

Eligibility Criteria

Inclusion Criteria

  • 13-17 years of age;
  • having engaged in deliberate self-harm (DSH)-behaviours ≥ 5 times the last year;
  • having engaged in ≥1 DSH episode during the past month;
  • having ongoing psychiatric treatment in the community;
  • having at least one caregiver or other significant adult, committed to participate in the parent program; and
  • stability of psychotropic medications

Exclusion Criteria

  • a diagnosis of psychotic, bipolar I disorder or severe social anxiety disorder (SAD);
  • ongoing substance dependence;
  • the presence of co-occurring psychiatric disorders that require immediate treatment;
  • having an autism spectrum disorder together with borderline intellectual disability or having an intellectual disability;
  • insufficient understanding of the Swedish language

Outcomes

Primary Outcomes

Feasibility measures, attrition

Time Frame: Pre-treatment to post-treatment EOT (12 weeks)

Attrition, percent of included participants who drops out of treatment (lower = better, min 0%- max 100%)

Feasibility measures, compliance

Time Frame: Pre-treatment to post-treatment (End of treatment, EOT) (12 weeks)

Compliance, no of sessions attended (\>50%), (higher = better, min 0-max 10)

Feasibility measure, recruitment rate

Time Frame: through study completion, an average of 1 year

Recruitment rate

Feasibility measures, client satisfaction

Time Frame: at post-treatment EOT (12 weeks)

Mean score on Client satisfaction questionnaire\> 25 (higher= better, min 8-max 32)

Feasibility measures, proportion included

Time Frame: through study completion, an average of 1 year

Proportion of participants invited to participate who accepts and is included (higher = better, min 0%- max 100%)

Feasibility measures, negative effects of treatment

Time Frame: at post-treatment EOT (12 weeks)

Low rating on Negative effects Questionnaire (lower= better, min 0-max 20)

Secondary Outcomes

  • Preliminary effect, emotion dysregulation EOT(Pre-treatment to post-treatment (EOT) (12 weeks))
  • Preliminary effect, self harm frequency 1MFU(Post-treatment (EOT) to follow-up (4 weeks))
  • Preliminary effect, emotion dysregulation 1MFU(Post-treatment (EOT) to follow-up (4 weeks))
  • Preliminary effect, self harm frequency EOT(Pre-treatment to post-treatment (EOT) (12 weeks))

Study Sites (1)

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