Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06324864
Status:
RECRUITING
Last Update Posted:
2024-03-22
First Post:
2024-03-15
Brief Title:
START NOW Adapted Culturally Adapted Version of START NOW
Sponsor:
Prof Christina Stadler
Organization:
University Psychiatric Clinics Basel
Study Overview
Official Title:
Testing the Effectiveness of a Cultural-Adapted Skills-Training to Reduce Mental Health Problems in Migrants
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None