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Recruiting NCT06324864

START NOW Adapted: Culturally Adapted Version of START NOW

No phase Interventional Depression Depression/Anxiety Anxiety Adolescent

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: START NOW Adapted.
Who it may be relevant to
Registry conditions: Depression, Depression/Anxiety, Anxiety, Adolescent. Basic parameters: 14 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Testing the Effectiveness of the Culturally Adapted Skills Training START NOW to Reduce Mental Health Problems in Adolescent Refugees

Overview

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.

Interventions

  • Behavioral START NOW Adapted
    The 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 diff

Primary outcome measures

  • Change from baseline in symptoms of depression and anxiety at the end of the intervention [Time frame: From enrollment to the end of treatment at week 14]
  • Change from baseline in symptoms of depression and anxiety at follow-up [Time frame: From enrollment to follow-up at week 26]
Secondary outcome measures (6)
  • Change from baseline in self-reported perceived stress at follow-up [Time frame: From enrollment to follow-up at week 26]
  • Change from baseline in self-reported social-ecological resilience at the end of the intervention [Time frame: From enrollment to the end of treatment at week 14]
  • Change from baseline in self-reported perceived stress at the end of the intervention [Time frame: From enrollment to the end of treatment at week 14]
  • Change from baseline in self-reported social-ecological resilience at follow-up [Time frame: From enrollment to the end of treatment at week 14]
  • Change from baseline in facial emotion recognition at the end of the intervention [Time frame: From enrollment to the end of treatment at week 14]
  • Change from baseline in facial emotion recognition at follow-up [Time frame: From enrollment to follow-up at week 26]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Switzerland · 1 center
  • University Psychiatric Clinics Basel — Basel

Publications

  • 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 Psy PMID 37814906
  • 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. PMID 38919921

Identifiers

NCT: NCT06324864 · 2024-00212

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗