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临床试验/NCT06237608
NCT06237608已完成不适用

Acceptability and Feasibility of an Adapted DBT-informed Skills Group for Gender Diverse Young People Co-delivered in a Charity Setting

King's College London2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2024年2月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
2
主要终点
Feasibility of intervention

研究概览

简要总结

Gender diverse (e.g. trans or non-binary) young people are at higher risk of self-harm and may be more likely to access support through gender-diverse-specific 3rd sector charities. Dialectical behavioural therapy (DBT) is a transdiagnostic intervention targeting emotion dysregulation, self-harm and suicidality and is recommended by best-practice clinical guidelines; There is developing evidence that DBT skills training can be offered as an effective stand-alone intervention.The current study, therefore, aims to evaluate the feasibility, acceptability and early indicators of effectiveness of a DBT-informed skills group intervention in a gender diverse charity setting. The intervention will be co-facilitated with a gender-diverse support worker from the charity to develop the therapeutic skills of the charity staff working with the young people, whilst they provide specialist knowledge and valuable lived experience.

Research questions

  1. Is the intervention feasible to deliver in a charity setting?
  2. Is the intervention acceptable to participants and charity facilitators?

Participants will attend a 16-week group intervention. They will complete questionnaire to assess acceptability at the end of the intervention. Attrition rates, training time, and questionnaires will be used to assess feasibility. Outcome measures will also be completed by the participants every three weeks to indicate possible effectiveness of the intervention. The outcomes will include emotion dysregulation, coping skills, anxiety, depression and suicidal behaviours.

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
16 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age 16-25 years old
  • Identify as gender diverse
  • Receiving support from Gendered Intelligence
  • Support worker identified and self-report emotion regulation difficulties.

排除标准

  • In acute crisis at point of recruitment and start of the intervention such as active suicidal ideation with active plans, or severe self-harm requiring intensive interventions such as inpatient or crisis care.

结局指标

主要结局

Feasibility of intervention

时间窗: 16 weeks

1\. Eligibility rates at screening

Acceptability of intervention

时间窗: 16 weeks

1\. Short, bespoke feedback questionnaire completed at the end of each session regarding content and delivery.

次要结局

  • Anxiety(Every 2 weeks for 4 weeks, and then again after 16 weeks.)
  • Emotion dysregulation(Every 2 weeks for 4 weeks, and then every three weeks for 16 weeks once the intervention begins.)
  • Use of DBT coping skills(Every 2 weeks for 4 weeks, and then every three weeks for 16 weeks once the intervention begins.)
  • Depression(Every 2 weeks for 4 weeks, and then again after 16 weeks.)
  • Gender-related negative future expectations(Every 2 weeks for 4 weeks, and then again after 16 weeks.)
  • Gender-specific pride(Every 2 weeks for 4 weeks, and then every three weeks for 16 weeks once the intervention begins.)
  • Internalised transphobia(Every 2 weeks for 4 weeks, and then every three weeks for 16 weeks once the intervention begins.)
  • Gender-related community connectedness(Every 2 weeks for 4 weeks, and then every three weeks for 16 weeks once the intervention begins.)
  • Suicidal behaviours(Every 2 weeks for 4 weeks, and then every three weeks for 16 weeks once the intervention begins.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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