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临床试验/NCT06297824
NCT06297824已完成不适用

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

Karolinska Institutet2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2023年10月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
21
试验地点
2
主要终点
Feasibility measures, attrition

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
13 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: ERGT-A (Behavioral)

结局指标

主要结局

Feasibility measures, attrition

时间窗: 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

时间窗: 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

时间窗: through study completion, an average of 1 year

Recruitment rate

Feasibility measures, client satisfaction

时间窗: at post-treatment EOT (12 weeks)

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

Feasibility measures, proportion included

时间窗: 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

时间窗: at post-treatment EOT (12 weeks)

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

次要结局

  • 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))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hanna Sahlin

Principal Investigator, PhD

Karolinska Institutet

研究点 (2)

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