START NOW Adapted: Culturally Adapted Version of START NOW

NCT06324864 | Recruiting DMC

• 1 other identifier: 2024-00212
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Refugee Health; Depression; Depression/Anxiety; Anxiety; Adolescent; Emotion Recognition; Mental Health; Resilience,Psychological

Keywords

randomized controlled trial; effectiveness trial; refugee health; cultural adaptation; skills-training; adolescent migrants

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Change from baseline in self-reported perceived stress at follow-up

  From enrollment to follow-up at week 26

• Change from baseline in self-reported social-ecological resilience at the end of the intervention

  From enrollment to the end of treatment at week 14

• Change from baseline in self-reported perceived stress at the end of the intervention

  From enrollment to the end of treatment at week 14

• Change from baseline in self-reported social-ecological resilience at follow-up

  From enrollment to the end of treatment at week 14

• Change from baseline in facial emotion recognition at the end of the intervention

  From enrollment to the end of treatment at week 14

Study Arms (2)

START NOW Adapted

ACTIVE COMPARATOR

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

Treatment as Usual

NO INTERVENTION

The control group will receive treatment as usual.

Interventions

START NOW Adapted BEHAVIORAL

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.

START NOW Adapted

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prof. Christina Stadler: lead

Study Sites (1)

University Psychiatric Clinics Basel

Basel, Canton of Basel-City, 4002, Switzerland

RECRUITING

Related Publications (2)

• 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.

  PMID: 37814906 BACKGROUND

• 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 RESULT

MeSH Terms

Conditions

Depression; Anxiety Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Personal Satisfaction

Study Officials

• Janine Bacher, MSc

  University Psychiatric Clinics Basel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Janine Bacher, MSc

CONTACT

+41 61 325 8048; janine.bacher@upk.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. Dr.

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: March 22, 2024
• Study Start: March 13, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)