An RCT Study Investigating the Effectiveness of Emotion Focused Skills Training (EFST)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Change in childrens symptoms and diagnosis
研究概览
简要总结
Comparing the effectivity of an EFST parent supervision intervention against Treatment As Usual in an outpatient specialist health care clinics Family unit.
详细描述
The aim of this study is to compare two different treatment conditions and their effect on the mental health of children and adolescent clients.
The first condition is the typical mental health treatment offered when the family is motivated to receive family based interventions in the clinic, thus, treatment as usual TAU as provided by the cliniques family team. A prior study, including data from the same clinic, found that the TAU was associated with good outcomes, identifying effect sizes equal to what is usual in clinical studies
The second condition, labelled: EFST intervention is a parent guidance intervention delivered as a two-day intensive group course followed by six weekly guidance sessions for parents of children with mental health issues.
Both treatment conditions are currently delivered at the clinic and by randomly assigning clients to each of these we will be able to compare the effects they have on the mental health of children and adolescents. The results will possibly guide what treatments to offer in the future.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with a wide range of diagnosis will be included.
- •Children in the age group from 6-18 years in the mental health clinic will be invited to participate.
- •It is preferred that both parents participate in the EFST treatment.
排除标准
- •parents need to live with the child at least 50% of the time (if separated or divorced)
- •Parents need to speak Norwegian to a degree that they can comprehend the psychoeducation and participate in the sessions without an interpreter.
- •parents with ongoing substance abuse or mental states that make participation too difficult, e.g., psychosis, will be excluded.
结局指标
主要结局
Change in childrens symptoms and diagnosis
时间窗: T0=At randomization, T1= 3 months after T0
To establish and measure change in childrens symptoms and diagnosis of mental distress, our main outcome measure will be the semi-structured diagnostic interview Schedule for Affective Disorders and Schizophrenia, present and lifetime version (Kiddie-SADS-PL), DSM-IV version (Kaufman, 1997). the Kiddie-sads will be completed at randomization and then repeated after 3 months to investigate the presence of diagnosis. A diagnosis will be rated as present or not present, with the threshold for presence being defined as a score of at least 3 within each diagnosis.
Change in reported symptoms and distress
时间窗: T0 = At randomization, T1 = 3 months after T0, T2 = 6 months after T0, T3 = 12 months after T0
To measure change in childrens symptoms of mental distress, the Strength and Difficulties Questionnaire, SDQ (Goodman et al., 2000) will be used. The child will be filling it out him/herself electronically (from 11 yeas of age), as well as the parents and teacher. The SDQ consists of 25 items describing positive and negative attributes of children and adolescents that can be allocated to 5 subscales. Each item has to be scored on a 3-point scale with 0 = 'not true', 1 = 'somewhat true', and 2 = 'certainly true'. A total difficulties score will also be calculated(range 0-40).Lower scores indicates better outcome.
次要结局
- Change in reported Health-Related Quality of Life(T0 = At randomization, T1 = 3 months after T0, T2 = 6 months after T0, T3 = 12 months after T0)
- Changes in parents emotional style(T0 = At randomization, T1 = 3 months after T0, T2 = 6 months after T0, T3 = 12 months after T0)
- Changes in parents emotion regulation(T0 = At randomization, T1 = 3 months after T0, T2 = 6 months after T0, T3 = 12 months after T0)
- Change in parents symptoms mental distress(T0 = At randomization, T1 = 3 months after)
- Change in the quality of parents relationship with child(T0 = At randomization, T1 = 3 months after T0, T2 = 6 months after T0, T3 = 12 months after T0)