Feasibility of Emotion Regulation Group Therapy for Adolescent Self-Harm

NCT06297824 | Completed

• 1 other identifier: 2023-04909-01
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Self-harm; Emotion Regulation; Adolescent - Emotional Problem

Keywords

self-harm; Emotion regulation; Group treatment; Adolescents

Outcome Measures

Primary Outcomes (6)

• Feasibility measure, recruitment rate

  Recruitment rate

  through study completion, an average of 1 year

• 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

• 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)

• 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)

• Feasibility measures, client satisfaction

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

  at post-treatment EOT (12 weeks)

• 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 Outcomes (4)

• Preliminary effect, self harm frequency 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 EOT

  Pre-treatment to post-treatment (EOT) (12 weeks)

• Preliminary effect, emotion dysregulation 1MFU

  Post-treatment (EOT) to follow-up (4 weeks)

Study Arms (1)

ERGT-A

OTHER

12 session emotion regulation treatment in group format. Psychoeducation and homework assignments. Subjects taught are the function of deliberate self-harm (DSH), functionality of emotions, negative consequences of emotional avoidance, non-avoidant emotion regulation.

Behavioral: ERGT-A

Interventions

ERGT-A BEHAVIORAL

Emotion regulation group therapy for adolescents

ERGT-A

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Prima Barn och Vuxenpsykiatri Handen och Järva

Stockholm, Spånga, 16374, Sweden

Location

MeSH Terms

Conditions

Self-Injurious Behavior; Emotional Regulation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Self-Control; Social Behavior

Study Officials

• Hanna Sahlin, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, PhD

Model Details: Feasibility, open trial

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: March 7, 2024
• Study Start: October 10, 2023
• Primary Completion: March 10, 2025
• Study Completion: March 10, 2025
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)