Feasibility of Emotion Regulation Group Therapy for Adolescent Self-Harm

Emotion Regulation Clinical Trial

— ERGT-A  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06297824
• Other study ID #: 2023-04909-01
• Status: Recruiting
• Phase: N/A
• Start date: October 10, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: March 2024
• Source: Karolinska Institutet
• Contact: Dimitar Krastev, MSc
• Phone: +46735269516
• Email: Dimitar.Krastev[@]prima.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

Inclusion Criteria:

1. 13-17 years of age;

2. having engaged in deliberate self-harm (DSH)-behaviours = 5 times the last year;

3. having engaged in =1 DSH episode during the past month;

4. having ongoing psychiatric treatment in the community;

5. having at least one caregiver or other significant adult, committed to participate in the parent program; and

6. stability of psychotropic medications

Exclusion Criteria:

1. a diagnosis of psychotic, bipolar I disorder or severe social anxiety disorder (SAD);

2. ongoing substance dependence;

3. the presence of co-occurring psychiatric disorders that require immediate treatment;

4. having an autism spectrum disorder together with borderline intellectual disability or having an intellectual disability;

5. insufficient understanding of the Swedish language

Related Conditions & MeSH terms

• Adolescent - Emotional Problem
• Emotion Regulation
• Self-harm
• Self-Injurious Behavior

Intervention

Behavioral:
• ERGT-A
Emotion regulation group therapy for adolescents

Locations

Country	Name	City	State
Sweden	Prima Barn och Vuxenpsykiatri Handen och Järva	Stockholm	Spånga

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility measure, recruitment rate	Recruitment rate	through study completion, an average of 1 year
Primary	Feasibility measures, proportion included	Proportion of participants invited to participate who accepts and is included (higher = better, min 0%- max 100%)	through study completion, an average of 1 year
Primary	Feasibility measures, compliance	Compliance, no of sessions attended (>50%), (higher = better, min 0-max 10)	Pre-treatment to post-treatment (End of treatment, EOT) (12 weeks)
Primary	Feasibility measures, attrition	Attrition, percent of included participants who drops out of treatment (lower = better, min 0%- max 100%)	Pre-treatment to post-treatment EOT (12 weeks)
Primary	Feasibility measures, client satisfaction	Mean score on Client satisfaction questionnaire> 25 (higher= better, min 8-max 32)	at post-treatment EOT (12 weeks)
Primary	Feasibility measures, negative effects of treatment	Low rating on Negative effects Questionnaire (lower= better, min 0-max 20)	at post-treatment EOT (12 weeks)
Secondary	Preliminary effect, self harm frequency EOT	Mean Deliberate self-harm frequency at post-treatment (min 0-max 100, lower=better)	Pre-treatment to post-treatment (EOT) (12 weeks)
Secondary	Preliminary effect, self harm frequency 1MFU	Mean Deliberate self-harm frequency at post-treatment and 1MFU lower than at post-treatment (min 0-max 100, lower=better)	Post-treatment (EOT) to follow-up (4 weeks)
Secondary	Preliminary effect, emotion dysregulation EOT	Mean difficulty in emotion regulation rating (DERS-16) at post-treatment lower than at pre-treatment (min 16, max 80, lower=better)	Pre-treatment to post-treatment (EOT) (12 weeks)
Secondary	Preliminary effect, emotion dysregulation 1MFU	Mean difficulty in emotion regulation rating (DERS-16) at 1MFU lower than at post-treatment (min 16, max 80, lower=better)	Post-treatment (EOT) to follow-up (4 weeks)