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.
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
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
Parallel
START NOW Adapted
BehavioralThe START NOW skills-training combines aspects of cognitive behavioral therapy (CBT), motivational interviewing (MI), dialectical behavior therapy (DBT), Acceptance and Commitment Therapy (ACT) and trauma-sensitive care. Studies in different contexts have shown START NOW's effectiveness in terms of reducing behavioral problems, reducing hospitalization rates, improving mental health functioning and increasing satisfaction rates. The culturally adapted version will be contextually adapted to different cultural backgrounds and the experience of migration. In ten sessions, participants learn about emotions and are introduced to the START NOW skills. These skills, called "SLOW DOWN", "TAKE A STEP BACK", "ACCEPT", "RESPECT" and "TAKE ACTION", are strategies or techniques that can be used to better manage stress and difficult emotions.
Change from baseline in symptoms of depression and anxiety at the end of the intervention
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
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 self-reported perceived stress at follow-up
Perceived stress will be measured by the Perceived Stress Scale-10 (PSS-10). The PSS-10 is a 10-item self-report questionnaire including two subscales, on which participants report life as unpredictable, uncontrollable, and overloading over the previous month. Answers are given on a 5-point Likert Scale (0 = never, 4 = very often). Higher scores indicate higher levels of perceived stress. We chose perceived stress as a secondary endpoint because the many pre-, peri- and post-migration stressors that are risk factors for refugees' mental health could be better managed through the intervention aimed at improving distress tolerance.
Change from baseline in self-reported social-ecological resilience at the end of the intervention
Social-ecological resilience will be measured by the Child and Youth Resilience Measure (CYRM-R). The CYRM-R is a 17-item self-report questionnaire measuring resilience that has been validated in 11 different countries. Items include social integration and support, autonomy and fair treatment and can be answered on a 3- point Likert Scale (1 = no, 3 = yes). Higher scores hereby indicate more available protective factors and higher social-ecological resilience. We chose this secondary endpoint because it has often been used to assess the effectiveness of interventions in pre-post and longitudinal designs.
Change from baseline in self-reported perceived stress at the end of the intervention
Perceived stress will be measured by the Perceived Stress Scale (PSS-10). The PSS-10 is a 10-item self-report questionnaire including two subscales, on which participants report life as unpredictable, uncontrollable, and overloading over the previous month. Answers are given on a 5-point Likert Scale (0 = never, 4 = very often). Higher scores indicate higher levels of perceived stress. We chose perceived stress as a secondary endpoint because the many pre-, peri- and post-migration stressors that are risk factors for refugees' mental health could be better managed through the intervention aimed at improving distress tolerance.
Change from baseline in self-reported social-ecological resilience at follow-up
Social-ecological resilience will be measured by the Child and Youth Resilience Measure (CYRM-R). The CYRM-R is a 17-item self-report questionnaire measuring resilience that has been validated in 11 different countries. Items include social integration and support, autonomy and fair treatment and can be answered on a 3- point Likert Scale (1 = no, 3 = yes). Higher scores hereby indicate more available protective factors and higher social-ecological resilience. We chose this secondary endpoint because it has often been used to assess the effectiveness of interventions in pre-post and longitudinal designs.
Click on the lead sponsor to view all of their trials.
Prof. Christina Stadler
Lead sponsor
University Psychiatric Clinics Basel
Sponsor institution
