Clinical trial NCT06324864: START NOW Adapted: Culturally Adapted Version of START NOW
Official title: Testing the Effectiveness of the Culturally Adapted Skills Training START NOW to Reduce Mental Health Problems in Adolescent Refugees
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Depression/Anxiety
Anxiety
Adolescent
Emotion Recognition
Mental Health
Resilience,Psychological
Refugee Health
Keywords: randomized controlled trial
effectiveness trial
refugee health
cultural adaptation
skills-training
adolescent migrants
Lead sponsor: University Psychiatric Clinics Basel
Sponsor class: NETWORK
First posted: 2024-03-22
Enrollment: 80
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
measure: Change from baseline in symptoms of depression and anxiety at follow-up
timeFrame: From enrollment to follow-up at week 26
Secondary outcomes:
measure: Change from baseline in self-reported perceived stress at follow-up
timeFrame: From enrollment to follow-up at week 26
measure: Change from baseline in self-reported social-ecological resilience at the end of the intervention
timeFrame: From enrollment to the end of treatment at week 14
measure: Change from baseline in self-reported perceived stress at the end of the intervention
timeFrame: From enrollment to the end of treatment at week 14
measure: Change from baseline in self-reported social-ecological resilience at follow-up
timeFrame: From enrollment to the end of treatment at week 14
measure: Change from baseline in facial emotion recognition at the end of the intervention
timeFrame: From enrollment to the end of treatment at week 14
measure: Change from baseline in facial emotion recognition at follow-up
timeFrame: From enrollment to follow-up at week 26
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Psychiatric Clinics Basel
state: Basel-Stadt
Study officials:
affiliation: University Psychiatric Clinics Basel
name: Janine Bacher, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bacher J, Stadler C, Unternaehrer E, Brunner D. Testing the effectiveness of the culturally adapted skills training START NOW to reduce mental health problems in adolescent refugees: study protocol for a randomized controlled trial. Front Public Health. 2024 Jun 11;12:1408026. doi: 10.3389/fpubh.2024.1408026. eCollection 2024.
citation: Stadler C, Freitag CM, Popma A, Nauta-Jansen L, Konrad K, Unternaehrer E, Ackermann K, Bernhard A, Martinelli A, Oldenhof H, Gundlach M, Kohls G, Pratzlich M, Kieser M, Limprecht R, Raschle NM, Vriends N, Trestman RL, Kirchner M, Kersten L. START NOW: a cognitive behavioral skills training for adolescent girls with conduct or oppositional defiant disorder - a randomized clinical trial. J Child Psychol Psychiatry. 2024 Mar;65(3):316-327. doi: 10.1111/jcpp.13896. Epub 2023 Oct 10.