START NOW Adapted: Culturally adapted version of START NOW
Summary description of the study
Young people with refugee experience have faced several difficult situations, crises, and stress in their lives. Unfortunately, there are also barriers to accessing health services. To provide an easily accessible training, we have culturally adapted the START NOW training. With this training, young people can train their resilience, i.e., their psychological resistance. Resilient individuals cope better with difficult situations and remain mentally healthy for longer. The aim is to find out in a randomized study plan with a treatment condition and a waiting group whether START NOW in the culturally adapted version is effective.
(BASEC)
Intervention under investigation
Specifically, it will be investigated whether the START NOW training in the culturally adapted version is effective.
(BASEC)
Disease under investigation
Adolescents who have good resilience experience fewer psychological difficulties; they can better cope with stress and challenges. Promoting resilience is therefore a central approach to fostering healthy psychological development. START NOW is a skills training for adolescents aged 12 and older to promote resilience and improve stress and emotion regulation (www.istartnow.ch). START NOW Adapted is a culturally adapted version of this.
(BASEC)
Refugee youth aged between 14 and 18 years, who live temporarily or permanently in Switzerland and wish to improve their mental health. (BASEC)
Exclusion criteria
Suicidality or participation in another training similar to START NOW. (BASEC)
Trial sites
Aarau, Basel, Bern, Luzern, Zurich, Other
(BASEC)
Solothurn, Jura
(BASEC)
Sponsor
Prof. Dr. Dr. Christina Stadler Universitäre Psychiatrische Kliniken Basel
(BASEC)
Contact
Contact Person Switzerland
Janine Bacher
+41613258048
janine.bacher@clutterupk.chUniversitäre Psychiatrische Kliniken Basel
(BASEC)
General Information
University Psychiatric Clinics Basel,
+41 61 325 8031;+410613258031
janine.bacher@clutterupk.ch(ICTRP)
Scientific Information
University Psychiatric Clinics Basel,
+41 61 325 8031;+410613258031
janine.bacher@clutterupk.ch(ICTRP)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee northwest/central Switzerland EKNZ
(BASEC)
Date of authorisation
13.03.2024
(BASEC)
ICTRP Trial ID
NCT06324864 (ICTRP)
Official title (approved by ethics committee)
Testing the effectiveness of the culturally adapted skills training START NOW to reduce mental health problems in adolescent refugees (BASEC)
Academic title
Testing the Effectiveness of the Culturally Adapted Skills Training START NOW to Reduce Mental Health Problems in Adolescent Refugees (ICTRP)
Public title
START NOW Adapted: Culturally Adapted Version of START NOW (ICTRP)
Disease under investigation
Depression;Depression/Anxiety;Anxiety;Adolescent;Emotion Recognition;Mental Health;Resilience,Psychological;Refugee Health (ICTRP)
Intervention under investigation
Behavioral: START NOW Adapted (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Inclusion/Exclusion criteria
Gender: All
Maximum age: 18 Years
Minimum age: 14 Years
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 (ICTRP)
not available
Primary and secondary end points
Change from baseline in symptoms of depression and anxiety at the end of the intervention;Change from baseline in symptoms of depression and anxiety at follow-up (ICTRP)
Change from baseline in self-reported perceived stress at follow-up;Change from baseline in self-reported social-ecological resilience at the end of the intervention;Change from baseline in self-reported perceived stress at the end of the intervention;Change from baseline in self-reported social-ecological resilience at follow-up;Change from baseline in facial emotion recognition at the end of the intervention;Change from baseline in facial emotion recognition at follow-up (ICTRP)
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
Donja Brunner, PhD;Donja Brunner, PhD;Donja Brunner, PhD, donja.brunner@unibas.ch, +41 61 325 8031;+410613258031, University Psychiatric Clinics Basel, (ICTRP)
Secondary trial IDs
2024-00212 (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT06324864 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available