Implementation, Cultural Adaptation, and Efficacy Evaluation of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) for Unaccompanied Refugee Minors in Greece

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This single-blinded, multicentered, randomized controlled trial aims to evaluate the effectiveness of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) compared to Treatment-as-Usual (TAU) in reducing post-traumatic stress symptoms among unaccompanied refugee minors (UAMs) residing in accommodation centers and Supported Independent Living (SIL) programs in Greece. Participants aged 15-18 will be randomly assigned to either a TF-CBT intervention group or a TAU control group. The intervention will be delivered by trained psychologists under supervision and culturally adapted to the Greek refugee context. Assessments will occur at baseline, post-intervention, and three months later, using standardized psychometric tools. Secondary outcomes include changes in comorbid psychiatric symptoms (depression, anxiety, somatic symptoms), emotional and behavioral difficulties, and quality of life. The study also investigates potential moderators of treatment response such as age, gender, trauma history, and psychiatric comorbidity.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 15
Maximum Age: 18
Healthy Volunteers: f
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• Be unaccompanied upon arrival in Greece and aged between 15-18 years old.

• Being diagnosed with PTSD based on DSM-5 criteria. Young refugees with post-traumatic stress symptoms (PTSS), as delineated by high or moderate trauma-related distress in the Child and Adolescent Trauma Screen (CATS), will also be eligible to participate in the study.

• Reside in an accommodation center or SIL program for UAMs in Greece.

• Have a stable living arrangement for at least 2-3 weeks prior to the intervention.

• Not be expected to relocate within the 2-3 months following the start of the intervention.

Locations
Other Locations
Greece
General Secretariat for Vulnerable Persons and Institutional Protection, Ministry of Migration and Asylum
RECRUITING
Athens
Contact Information
Primary
Theodora Anastasiou, PhD candidate
theodanastasiou@gmail.com
+306942883681
Time Frame
Start Date: 2023-04-13
Estimated Completion Date: 2026-02
Participants
Target number of participants: 60
Treatments
Experimental: Intervention Group (TF-CBT)
Participants in this arm will receive a structured therapeutic protocol based on trauma-focused cognitive behavioral therapy (TF-CBT), delivered over 12 weekly or bi-weekly sessions by trained psychologists in accommodation centers and Supported Independent Living (SIL) programs across Greece. The intervention includes psychoeducation, relaxation techniques, affective modulation, cognitive restructuring, development of a trauma narrative and trauma processing, in vivo exposure, and strategies to enhance safety and future planning. The program is specifically adapted for unaccompanied asylum-seeking minors (UAMs) presenting with symptoms of PTSD.
Active_comparator: Control group (TAU)
Participants in this arm will receive the standard support services (Treatment as Usual) provided in the accommodation centers and Supported Independent Living (SIL) programs, including routine clinical management and general psychological support, without engagement in a structured therapeutic framework or participation in the trauma-focused intervention. Access to the regular psychosocial services available to all residents will remain unchanged.
Related Therapeutic Areas
Sponsors
Collaborators: SOS Children's Villages, Greek Ministry of Migration and Asylum
Leads: Theodora Anastasiou

This content was sourced from clinicaltrials.gov