Clinical trial NCT06297824: Feasibility of Emotion Regulation Group Therapy for Adolescent Self-Harm
Official title: Can a Brief Emotion Regulation Group Therapy Help Adolescents With Deliberate Self-Harm? A Feasibility Study and a Qualitative Interview Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Self-harm
Emotion Regulation
Adolescent - Emotional Problem
Keywords: self-harm
Emotion regulation
Group treatment
Adolescents
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2024-03-07
Enrollment: 21
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Feasibility, open trial
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility measure, recruitment rate
timeFrame: through study completion, an average of 1 year
measure: Feasibility measures, proportion included
timeFrame: through study completion, an average of 1 year
measure: Feasibility measures, compliance
timeFrame: Pre-treatment to post-treatment (End of treatment, EOT) (12 weeks)
measure: Feasibility measures, attrition
timeFrame: Pre-treatment to post-treatment EOT (12 weeks)
measure: Feasibility measures, client satisfaction
timeFrame: at post-treatment EOT (12 weeks)
measure: Feasibility measures, negative effects of treatment
timeFrame: at post-treatment EOT (12 weeks)
Secondary outcomes:
measure: Preliminary effect, self harm frequency EOT
timeFrame: Pre-treatment to post-treatment (EOT) (12 weeks)
measure: Preliminary effect, self harm frequency 1MFU
timeFrame: Post-treatment (EOT) to follow-up (4 weeks)
measure: Preliminary effect, emotion dysregulation EOT
timeFrame: Pre-treatment to post-treatment (EOT) (12 weeks)
measure: Preliminary effect, emotion dysregulation 1MFU
timeFrame: Post-treatment (EOT) to follow-up (4 weeks)
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Prima Barn och Vuxenpsykiatri Handen och Järva
state: Spånga
Study officials:
affiliation: Karolinska Institutet
name: Hanna Sahlin, PhD
role: PRINCIPAL_INVESTIGATOR
References: