START NOW Adapted: Culturally Adapted Version of START NOW

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

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.

Study Overview

• Status: Recruiting
• Conditions: Adolescent; Depression; Anxiety; Mental Health; Emotion Recognition; Refugee Health; Resilience,Psychological; Depression/Anxiety
• Intervention / Treatment: Behavioral: START NOW Adapted

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Janine Bacher, MSc; Phone Number: +41 61 325 8048; Email: janine.bacher@upk.ch

Study Locations

• Switzerland
  • Canton of Basel-City
    • Basel, Canton of Basel-City, Switzerland, 4002
      • Recruiting
      • University Psychiatric Clinics Basel
      • Contact: Janine Bacher, MSc; Phone Number: +410613258048; Email: janine.bacher@upk.ch
      • Principal Investigator: Janine Bacher, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: START NOW Adapted; The intervention group will receive a culturally adapted version of the yet well-validated START NOW training. The skills taught within START NOW aim to change dysfunctional negative attitudes and behaviour, improve emotion regulation capacities and enhance the ability to achieve individual goals by addressing key aspects of mental health and resilience. The training includes 10 group sessions including exercises and discussion. The sessions will be held by a trained facilitator (staff member of institution, social worker, or else) with the same cultural background in the respective language (depending on group constellation) and supervised by a certified START NOW trainer from the START NOW team.	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 different cultural backgrounds and the experience of migration. In ten sessions, participants learn about emotions and are introduced to the START NOW skills. These skills, called "SLOW DOWN", "TAKE A STEP BACK", "ACCEPT", "RESPECT" and "TAKE ACTION", are strategies or techniques that can be used to better manage stress and difficult emotions.
No Intervention: Treatment as Usual; The control group will receive treatment as usual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in symptoms of depression and anxiety at the end of the intervention	Depression and anxiety will be measured by the Hopkins-Symptom-Checklist-25 (HSCL-25) questionnaire. The HSCL-25 is a 25-item self-report questionnaire, on which participants rate if physical, emotional, or psychological symptoms indicating depression, anxiety, and trauma have affected them over the past week. Answers are given on a 4-point Likert Scale (1 = not at all; 4 = extremely), and total scores can range from 25 to 100, with higher scores indicating greater levels of depression, anxiety and trauma, respectively. We chose symptoms of depression and anxiety as the primary endpoint because of their high self-reported prevalence of up to 42% in refugee populations.	From enrollment to the end of treatment at week 14
Change from baseline in symptoms of depression and anxiety at follow-up	Depression and anxiety will be measured by the Hopkins-Symptom-Checklist-25 (HSCL-25) questionnaire. The HSCL-25 is a 25-item self-report questionnaire, on which participants rate if physical, emotional, or psychological symptoms indicating depression, anxiety, and trauma have affected them over the past week. Answers are given on a 4-point Likert Scale (1 = not at all; 4 = extremely), and total scores can range from 25 to 100, with higher scores indicating greater levels of depression, anxiety and trauma, respectively. We chose symptoms of depression and anxiety as the primary endpoint because of their high self-reported prevalence of up to 42% in refugee populations.	From enrollment to follow-up at week 26

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in self-reported perceived stress at follow-up	Perceived stress will be measured by the Perceived Stress Scale-10 (PSS-10). The PSS-10 is a 10-item self-report questionnaire including two subscales, on which participants report life as unpredictable, uncontrollable, and overloading over the previous month. Answers are given on a 5-point Likert Scale (0 = never, 4 = very often). Higher scores indicate higher levels of perceived stress. We chose perceived stress as a secondary endpoint because the many pre-, peri- and post-migration stressors that are risk factors for refugees' mental health could be better managed through the intervention aimed at improving distress tolerance.	From enrollment to follow-up at week 26
Change from baseline in self-reported social-ecological resilience at the end of the intervention	Social-ecological resilience will be measured by the Child and Youth Resilience Measure (CYRM-R). The CYRM-R is a 17-item self-report questionnaire measuring resilience that has been validated in 11 different countries. Items include social integration and support, autonomy and fair treatment and can be answered on a 3- point Likert Scale (1 = no, 3 = yes). Higher scores hereby indicate more available protective factors and higher social-ecological resilience. We chose this secondary endpoint because it has often been used to assess the effectiveness of interventions in pre-post and longitudinal designs.	From enrollment to the end of treatment at week 14
Change from baseline in self-reported perceived stress at the end of the intervention	Perceived stress will be measured by the Perceived Stress Scale (PSS-10). The PSS-10 is a 10-item self-report questionnaire including two subscales, on which participants report life as unpredictable, uncontrollable, and overloading over the previous month. Answers are given on a 5-point Likert Scale (0 = never, 4 = very often). Higher scores indicate higher levels of perceived stress. We chose perceived stress as a secondary endpoint because the many pre-, peri- and post-migration stressors that are risk factors for refugees' mental health could be better managed through the intervention aimed at improving distress tolerance.	From enrollment to the end of treatment at week 14
Change from baseline in self-reported social-ecological resilience at follow-up	Social-ecological resilience will be measured by the Child and Youth Resilience Measure (CYRM-R). The CYRM-R is a 17-item self-report questionnaire measuring resilience that has been validated in 11 different countries. Items include social integration and support, autonomy and fair treatment and can be answered on a 3- point Likert Scale (1 = no, 3 = yes). Higher scores hereby indicate more available protective factors and higher social-ecological resilience. We chose this secondary endpoint because it has often been used to assess the effectiveness of interventions in pre-post and longitudinal designs.	From enrollment to the end of treatment at week 14
Change from baseline in facial emotion recognition at the end of the intervention	Facial emotion recognition will be measured using the Penn Emotion Recognition Task (ER-40). The ER-40 consists of 40 colour photographs of static multicultural faces expressing four basic emotions (i.e. happiness, sadness, anger or fear) and neutral expressions. Participants quickly select the appropriate emotion label for each face. They then rate their confidence in the accuracy of their response on a scale from 0 (not at all confident) to 100 (extremely confident). Accuracy scores range from 0 to 40. The ER-40 has strong psychometric properties and is recommended for use in clinical trials. We included the secondary endpoint facial emotion recognition (ER) as performance on measures of emotion recognition is a first step in emotion regulation.	From enrollment to the end of treatment at week 14
Change from baseline in facial emotion recognition at follow-up	Facial emotion recognition will be measured using the Penn Emotion Recognition Task (ER-40). The ER-40 consists of 40 colour photographs of static multicultural faces expressing four basic emotions (i.e. happiness, sadness, anger or fear) and neutral expressions. Participants quickly select the appropriate emotion label for each face. They then rate their confidence in the accuracy of their response on a scale from 0 (not at all confident) to 100 (extremely confident). Accuracy scores range from 0 to 40. The ER-40 has strong psychometric properties and is recommended for use in clinical trials. We included the secondary endpoint facial emotion recognition (ER) as performance on measures of emotion recognition is a first step in emotion regulation.	From enrollment to follow-up at week 26

Collaborators and Investigators

• Sponsor: Prof. Christina Stadler
• Investigators: Principal Investigator: Janine Bacher, MSc, University Psychiatric Clinics Basel

Publications and helpful links

General 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 Psychol Psychiatry. 2024 Mar;65(3):316-327. doi: 10.1111/jcpp.13896. Epub 2023 Oct 10.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: March 15, 2024
• First Submitted That Met QC Criteria: March 15, 2024
• First Posted (Actual): March 22, 2024

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: randomized controlled trial; effectiveness trial; cultural adaptation; refugee health; skills-training; adolescent migrants
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Behavior; Personal Satisfaction; Anxiety Disorders; Depression; Psychological Well-Being
• Other Study ID Numbers: 2024-00212

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No