START NOW Adapted: Culturally Adapted Version of START NOW (NCT06324864) | Clinical Trial Compass
RecruitingNot Applicable
START NOW Adapted: Culturally Adapted Version of START NOW
Switzerland80 participantsStarted 2024-03-13
Plain-language summary
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.
Who can participate
Age range
14 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline in symptoms of depression and anxiety at the end of the intervention
Timeframe: From enrollment to the end of treatment at week 14
2
Change from baseline in symptoms of depression and anxiety at follow-up
Timeframe: From enrollment to follow-up at week 26