Testing the Effectiveness of the Culturally Adapted Skills Training START NOW to Reduce Mental Health Problems in Adolescent Refugees
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change from baseline in symptoms of depression and anxiety at the end of the intervention
研究概览
简要总结
The goal of this clinical trial is to test the effectiveness of the culturally adapted skills-training START NOW in youth migrant populations. The main question it aims to answer is: Is the culturally adapted skills training START NOW more effective than treatment as usual (TAU) in reducing mental health problems in migrants? Participants will be randomly assigned to the intervention group receiving the skills training START NOW Adapted or the control group receiving TAU. Researchers will compare both groups to see if START NOW Adapted is more effective than TAU in reducing mental health problems in migrants.
详细描述
Over the last few decades, Europe has experienced one of the largest increases in international migration resulting from a combination of natural and man-made disasters. As these disasters cannot be expected to decrease in the future, it is essential to establish optimal healthcare for migrants, especially refugees. Due to several risk factors of their psychological well-being, refugees have higher prevalence rates of depression, post-traumatic stress disorder (PTSD) and other anxiety disorders compared to the host-country population. Adolescent refugees are particularly vulnerable to mental health problems, as they experience many risk factors associated with their resettlement during crucial phases of their physical and emotional development.
However, despite having a greater healthcare requirement than others, adolescent refugees encounter significant barriers in accessing healthcare services. The skills-training START NOW offers a low-threshold opportunity to treat this vulnerable population by promoting general psychological health and resilience.
Since effective psychological interventions are rooted in a cultural context and must be consistent with clients' cultural beliefs, there is a need to culturally adapt this existing intervention, which has previously been used with Western populations. Our study therefore aims to develop and evaluate a culturally adapted version of the existing START NOW skills-training.
The study is a monocentric, national, confirmatory randomized controlled trial with two arms, namely one intervention and one control group: 1) START NOW Adapted, 2) treatment as usual (TAU). Possible participants taking part in the intervention study are screened for eligibility. For those who are eligible, there will be three assessments: a baseline assessment (t1), a post-treatment assessment (t2), and a 12-weeks follow-up assessment (t3). Randomization into one of the two arms will take place after the baseline assessment (t1) has been conducted. Between t1 and t2, the intervention phase takes place over a period of ten weeks.
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
- 14 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being a migrant resettled in Switzerland temporarily or permanently
- •Aged between 14 and 18
- •Able to speak, read and understand one of the following languages: German, English, Turkish, Farsi, Dari, Ukrainian, Algerian Arabic or Pashto
- •Able to give informed consent as documented by signature
- •At least sub-clinical depressive symptoms assessed by the Hopkins Symptom Checklist-25 (HSCL-25); total score > 1.75, OR
- •Having elevated levels of psychological distress assessed by Kessler Psychological Distress Scale (K10); total score > 20
排除标准
- •Suicidality assessed in self-report by the Suicide Behaviors Questionnaire-Revised (SBQ-R; total score > 6) and external report by telephone clarification
- •Planning to leave Switzerland in the next 6 months
- •Concurrent CBT-based skills-training similar to START NOW
研究组 & 干预措施
START NOW Adapted
The intervention group will receive a culturally adapted version of the yet well-validated START NOW training. The skills taught within START NOW aim to change dysfunctional negative attitudes and behaviour, improve emotion regulation capacities and enhance the ability to achieve individual goals by addressing key aspects of mental health and resilience. The training includes 10 group sessions including exercises and discussion.
The sessions will be held by a trained facilitator (staff member of institution, social worker, or else) with the same cultural background in the respective language (depending on group constellation) and supervised by a certified START NOW trainer from the START NOW team.
干预措施: START NOW Adapted (Behavioral)
Treatment as Usual
The control group will receive treatment as usual.
结局指标
主要结局
Change from baseline in symptoms of depression and anxiety at the end of the intervention
时间窗: From enrollment to the end of treatment at week 14
Depression and anxiety will be measured by the Hopkins-Symptom-Checklist-25 (HSCL-25) questionnaire. The HSCL-25 is a 25-item self-report questionnaire, on which participants rate if physical, emotional, or psychological symptoms indicating depression, anxiety, and trauma have affected them over the past week. Answers are given on a 4-point Likert Scale (1 = not at all; 4 = extremely), and total scores can range from 25 to 100, with higher scores indicating greater levels of depression, anxiety and trauma, respectively. We chose symptoms of depression and anxiety as the primary endpoint because of their high self-reported prevalence of up to 42% in refugee populations.
Change from baseline in symptoms of depression and anxiety at follow-up
时间窗: From enrollment to follow-up at week 26
Depression and anxiety will be measured by the Hopkins-Symptom-Checklist-25 (HSCL-25) questionnaire. The HSCL-25 is a 25-item self-report questionnaire, on which participants rate if physical, emotional, or psychological symptoms indicating depression, anxiety, and trauma have affected them over the past week. Answers are given on a 4-point Likert Scale (1 = not at all; 4 = extremely), and total scores can range from 25 to 100, with higher scores indicating greater levels of depression, anxiety and trauma, respectively. We chose symptoms of depression and anxiety as the primary endpoint because of their high self-reported prevalence of up to 42% in refugee populations.
次要结局
- Change from baseline in self-reported perceived stress at the end of the intervention(From enrollment to the end of treatment at week 14)
- Change from baseline in self-reported social-ecological resilience at the end of the intervention(From enrollment to the end of treatment at week 14)
- Change from baseline in facial emotion recognition at the end of the intervention(From enrollment to the end of treatment at week 14)
- Change from baseline in self-reported perceived stress at follow-up(From enrollment to follow-up at week 26)
- Change from baseline in self-reported social-ecological resilience at follow-up(From enrollment to the end of treatment at week 14)
- Change from baseline in facial emotion recognition at follow-up(From enrollment to follow-up at week 26)
研究者
Prof. Christina Stadler
Prof. Dr. Dr.
University Psychiatric Clinics Basel