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临床试验/NCT05218031
NCT05218031Unknown不适用

Acceptance and Commitment Group Therapy for Unaccompanied Minors: A Pilot Study

University of Cyprus0 个研究点目标入组 70 人开始时间: 2022年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
70
主要终点
Change in 'The Depression, Anxiety and Stress Scale' (DASS-21; Lovibond & Lovibond, 1995; Antony, Bieling, Cox, Enns, & Swinson., 1998).

研究概览

简要总结

Unaccompanied minors (UM) are considered to be a highly vulnerable refugee subgroup. Research has indicated that UM experience traumatic events and consequently develop high levels of psychopathology. Post-traumatic stress disorder is the most prevalent diagnosis, followed by depression, anxiety disorders as well as traumatic grief and conduct problems. Acceptance and Commitment Therapy (ACT) may be particularly suited to the treatment of survivors of trauma and with vulnerable refugee groups such as UM. A 5-week ACT group intervention will be carried out and its feasibility in UM will be explored along with its effect on mental health. The ACT group intervention will be based on a Self-Help Booklet by the World Health Organization "Doing What Matters in Times of Stress: An Illustrated Guide". Following the 5-week ACT group intervention, focus groups with participants will be carried out to examine its acceptability and will be analysed qualitatively, using thematic analysis.

详细描述

The hypotheses of the study are as follows:

  1. The ACT group intervention will lead to increases in UM psychological well-being and quality of life compared to a waiting-list (WL) control group. This includes improvements in post-traumatic stress symptoms, depression, anxiety, stress, and sleep difficulties. (Primary outcomes).
  2. The UM receiving the ACT group intervention will demonstrate improvements in their prosocial behaviour compared to the WL control group. (Primary outcomes).
  3. At post-intervention, UM receiving the ACT group intervention will have enhanced psychological flexibility compared to the WL control group. It is predicted that there will be decreased experiential avoidance and cognitive fusion, coupled with increases in values-driven committed action, present moment awareness and self-as-context. (Secondary outcomes).
  4. At the 1-month and 3-month follow-up time points, the UM receiving the ACT group intervention will have retained the improvements from the treatment (i.e., increased psychological wellbeing, enhanced psychological flexibility, augmented prosocial behaviour) compared to the WL control group. Additionally, it is predicted that UM who completed the ACT group intervention will not only have sustained the benefits observed directly post-intervention but will in fact keep making progress at follow-up time points compared to the WL control group.

From the qualitative analysis, the investigators presume to provide critical insights as to what is perceived acceptable and culturally appropriate treatment for this population.

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
13 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Unaccompanied refugee minors living in sheltered accommodation in Cyprus.
  • •No specific diagnosis required to take part in the study.
  • •No specific cultural background required.
  • •Minors who provide consent.

排除标准

  • •Presence of active psychosis.

研究组 & 干预措施

ACT Intervention

Experimental

5-week ACT Group Intervention based on the Self-Help Booklet by the World Health Organization "Doing What Matters in Times of Stress: An Illustrated Guide".

干预措施: Acceptance and Commitment Therapy (Behavioral)

Control group

No Intervention

Waiting-list

结局指标

主要结局

Change in 'The Depression, Anxiety and Stress Scale' (DASS-21; Lovibond & Lovibond, 1995; Antony, Bieling, Cox, Enns, & Swinson., 1998).

时间窗: Pre-intervention, Post-intervention (at 5 weeks), 1-month follow-up, 3-months follow-up

This scale includes 21 items and will be used to assess for symptoms of depression, anxiety and stress in our sample. The Depression scale assesses hopelessness, low self-esteem, and low positive affect. The Anxiety scale assesses autonomic arousal, physiological hyperarousal, and the subjective feeling of fear. The Stress scale items assess tension, agitation, and negative affect. There are seven items per scale and participants must rate their past week on a Likert-type scale (0-3). Higher scores indicate higher levels of depression, stress and anxiety. Cronbach's alphas indicating high internal consistency for Depression .94, Anxiety .84 and Stress .91.

Change in 'Strengths and Difficulties Questionnaire' (SDQ; Goodman, 1997; 2001).

时间窗: Pre-intervention, Post-intervention (at 5 weeks), 1-month follow-up, 3-months follow-up

This questionnaire consists of 25 items divided into five subscales with 5 items each: Emotional difficulties, Conduct problems, Hyperactivity/inattention, Peer problems and Prosocial behaviour. Each item is scored on a 3-point scale (0= 'not true', 1='somewhat true', and 2= 'certainly true'). Subscale scores are calculated by summing scores on relevant items (after recoding reversed items). Higher scores on the prosocial behaviour subscale indicate strengths, whilst higher scores on the other four subscales indicate difficulties. A total difficulties score is computed by summing the scores on all five subscales (range 0-40). Reliability of this scale is satisfactory as assessed by internal consistency (Cronbach's alpha=0.73), cross-informant correlation (mean= 0.34), and retest stability after 4 to 6 months (mean= 0.62).

Change in 'Quality of Life': KIDSCREEN-27 (Ravens-Sieberer et al., 2007).

时间窗: Pre-intervention, Post-intervention (at 5 weeks), 1-month follow-up, 3-months follow-up

This is a 27-item instrument that consists of five dimensions of quality of life: physical well-being (5 items), psychological well-being (7 items), autonomy and relationship with parents (7 items), peers and social support (4 items), and school environment (4 items). The questions concern the last seven days and answers are given on a five-point Likert scale ('Not at all, slightly, moderately, very, extremely' or 'never, seldom, quite often, very often, always'). Higher scores on the KIDSCREEN-27 reflect higher quality of life and wellbeing. Internal consistency of this scale was considered satisfactory (Cronbach's alpha= \>.70).

Change in 'The Child Revised Impact of Events Scale' (CRIES-8; Perrin, Meiser-Stedman, & Smith., 2005).

时间窗: Pre-intervention, Post-intervention (at 5 weeks), 1-month follow-up, 3-months follow-up

This scale will be used to assess for any post-traumatic stress symptoms. The total number of items in the scale are 8 items. Four of the items assess intrusion (intrusive thoughts, feelings) and the remaining four items assess avoidance (avoidance of situations, feelings). The items are scored on a 4- point scale, where higher scores indicate higher levels of intrusion or avoidance. The CRIES-13 (Smith, Perrin, Dyregov, \& Yule, 2003) was found to have high internal consistency (Cronbach's alpha= 0.80). Sensitivity (i.e., the probability that someone with a diagnosis of PTSD will screen positive) was found to be .94-1.0. Specificity (i.e., the probability that someone without a diagnosis of PTSD will screen negative) was found to be .59-.71. The overall efficiency rate of the CRIES-8 is 75-82.7%.

次要结局

  • Change in the ACT Process Measure: PsyFlex (Gloster et al., 2021).(Pre-intervention, throughout study completion 5 weeks, 1-month follow-up, 3-months follow-up)

研究者

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

Maria Karekla

Associate Professor

University of Cyprus

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