Informazioni generali
  • Categoria della malattia Malattie mentali / psichiche e comportamentali , Altro (BASEC)
  • Fase dello studio N/A (ICTRP)
  • Stato di reclutamento reclutamento in corso (BASEC/ICTRP)
  • Luogo dello studio
    Aarau, Basilea, Berna, Luzern, Zurigo, Altro
    (BASEC)
  • Responsabile dello studio Janine Bacher janine.bacher@upk.ch (BASEC)
  • Fonte dati BASEC: Importato da 19.05.2025 ICTRP: Importato da 31.01.2025
  • Ultimo aggiornamento 19.05.2025 09:31
HumRes64880 | SNCTP000005838 | BASEC2024-00212 | NCT06324864

START NOW Adapted: Culturally adapted version of START NOW

  • Categoria della malattia Malattie mentali / psichiche e comportamentali , Altro (BASEC)
  • Fase dello studio N/A (ICTRP)
  • Stato di reclutamento reclutamento in corso (BASEC/ICTRP)
  • Luogo dello studio
    Aarau, Basilea, Berna, Luzern, Zurigo, Altro
    (BASEC)
  • Responsabile dello studio Janine Bacher janine.bacher@upk.ch (BASEC)
  • Fonte dati BASEC: Importato da 19.05.2025 ICTRP: Importato da 31.01.2025
  • Ultimo aggiornamento 19.05.2025 09:31

Descrizione riassuntiva dello studio

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)

Intervento studiato

Specifically, it will be investigated whether the START NOW training in the culturally adapted version is effective.

(BASEC)

Malattie studiate

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)

Criteri di partecipazione
Refugee youth aged between 14 and 18 years, who live temporarily or permanently in Switzerland and wish to improve their mental health. (BASEC)

Criteri di esclusione
Suicidality or participation in another training similar to START NOW. (BASEC)

Luogo dello studio

Aarau, Basilea, Berna, Luzern, Zurigo, Altro

(BASEC)

Solothurn, Jura

(BASEC)

Switzerland (ICTRP)

Sponsor

Prof. Dr. Dr. Christina Stadler Universitäre Psychiatrische Kliniken Basel

(BASEC)

Contatto per ulteriori informazioni sullo studio

Persona di contatto in Svizzera

Janine Bacher

+41613258048

janine.bacher@upk.ch

Universitäre Psychiatrische Kliniken Basel

(BASEC)

Informazioni generali

University Psychiatric Clinics Basel,

+41 61 325 8031;+410613258031

janine.bacher@upk.ch

(ICTRP)

Informazioni scientifiche

University Psychiatric Clinics Basel,

+41 61 325 8031;+410613258031

janine.bacher@upk.ch

(ICTRP)

Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)

Commissione d'etica svizzera nord-ovest/centrale EKNZ

(BASEC)

Data di approvazione del comitato etico

13.03.2024

(BASEC)


ID di studio ICTRP
NCT06324864 (ICTRP)

Titolo ufficiale (approvato dal comitato etico)
Testing the effectiveness of the culturally adapted skills training START NOW to reduce mental health problems in adolescent refugees (BASEC)

Titolo accademico
Testing the Effectiveness of the Culturally Adapted Skills Training START NOW to Reduce Mental Health Problems in Adolescent Refugees (ICTRP)

Titolo pubblico
START NOW Adapted: Culturally Adapted Version of START NOW (ICTRP)

Malattie studiate
Depression;Depression/Anxiety;Anxiety;Adolescent;Emotion Recognition;Mental Health;Resilience,Psychological;Refugee Health (ICTRP)

Intervento studiato
Behavioral: START NOW Adapted (ICTRP)

Tipo di studio
Interventional (ICTRP)

Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)

Criteri di inclusione/esclusione
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)

non disponibile

Endpoint primari e secondari
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)

Data di registrazione
non disponibile

Inclusione del primo partecipante
non disponibile

Sponsor secondari
non disponibile

Contatti aggiuntivi
Donja Brunner, PhD;Donja Brunner, PhD;Donja Brunner, PhD, donja.brunner@unibas.ch, +41 61 325 8031;+410613258031, University Psychiatric Clinics Basel, (ICTRP)

ID secondari
2024-00212 (ICTRP)

Risultati-Dati individuali dei partecipanti
non disponibile

Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT06324864 (ICTRP)

Risultati dello studio

Riepilogo dei risultati

non disponibile

Link ai risultati nel registro primario

non disponibile