START NOW Adapted: Culturally Adapted Version of START NOW

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-13

Study Completion Date

2026-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

START NOW Adapted

Intervention Type 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.

Treatment as Usual

The control group will receive treatment as usual.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

14 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No