Feasibility of Emotion Regulation Group Therapy for Adolescent Self-Harm (ERGT-A)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Emotion Regulation; Self-harm; Adolescent - Emotional Problem
• Intervention / Treatment: Behavioral: ERGT-A

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

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dimitar Krastev, MSc; Phone Number: +46735269516; Email: Dimitar.Krastev@prima.se

Study Locations

• Sweden
  • Spånga
    • Stockholm, Spånga, Sweden, 16374
      • Recruiting
      • Prima Barn och Vuxenpsykiatri Handen och Järva
      • Contact: Dimitar Krastev, MSc; Phone Number: +46735269516; Email: Dimitar.Krastev@prima.se
      • Contact: MaiBritt Giacobini, PhD; Phone Number: +46709736662; Email: Maibritt.Giacobini@prima.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: ERGT-A; 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; Emotion regulation group therapy for adolescents

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Principal Investigator: Hanna Sahlin, PhD, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: January 29, 2024
• First Submitted That Met QC Criteria: March 4, 2024
• First Posted (Actual): March 7, 2024

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Adolescents; Group treatment; Emotion regulation; self-harm
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior
• Other Study ID Numbers: 2023-04909-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No