START NOW Adapted: Culturally Adapted Version of START NOW

Depression Clinical Trial

Official title:

Testing the Effectiveness of a Cultural-Adapted Skills-Training to Reduce Mental Health Problems in Migrants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06324864
• Other study ID #: 2024-00212
• Status: Recruiting
• Phase: N/A
• Start date: March 13, 2024
• Est. completion date: March 2026

Study information

• Verified date: March 2024
• Source: University Psychiatric Clinics Basel
• Contact: Donja Brunner, PhD
• Phone: +41 61 325 8031
• Email: donja.brunner[@]unibas.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: March 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 18 Years

Eligibility

Inclusion Criteria:

• Being a migrant resettled in Switzerland temporarily or permanently
• Aged between 15 and 18
• Able to speak, read and understand one of the following languages: German, English, Turkish, Persian, Ukrainian, Arabic
• 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 by the Suicide Behaviors Questionnaire-Revised (SBQ-R); total score > 6
• Planning to leave Switzerland in the next 6 months
• Concurrent CBT-based skills-training similar to START NOW

Related Conditions & MeSH terms

• Adolescent
• Anxiety
• Anxiety Disorders
• Depression
• Depression/Anxiety
• Depressive Disorder
• Mental Health
• Resilience,Psychological

Intervention

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.

Locations

Country	Name	City	State
Switzerland	University Psychiatric Clinics Basel	Basel	Basel-Stadt

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Christina Stadler

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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