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RECRUITINGINTERVENTIONAL

Trauma-Focused Cognitive Behavioral Therapy in Unaccompanied Refugee Minors With PTSD in Greece: An RCT

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - a diagnosed intellectual disability (IQ \< 70) or another developmental disorder - acute suicidality or life-threatening self-harm behavior - significant risk of harm to others - comorbidity with bipolar disorder or a psychotic disorder - substance abuse. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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. Exclusion Criteria: * a diagnosed intellectual disability (IQ \< 70) or another developmental disorder * acute suicidality or life-threatening self-harm behavior * significant risk of harm to others * comorbidity with bipolar disorder or a psychotic disorder * substance abuse.

Treatments Being Tested

BEHAVIORAL

Trauma - Focused Cognitive Behavioral Therapy

TF-CBT is a comprehensive, evidence-based, short-term therapeutic protocol aimed at reducing trauma-related symptoms in children and adolescents aged 3-18. The protocol consists of 12 double sessions conducted with both the child and their caregiver. Developed for children who have experienced sexual abuse and multiple traumas, TF-CBT has since been successfully applied to a variety of traumatic experiences. Core components of the protocol include psychoeducation, relaxation techniques, emotional regulation, cognitive processing, trauma narrative, in vivo exposure, conjoint child/caregiver sessions, and safety planning. The intervention is culturally informed and flexible to meet individual needs. Adjustments have been made in the context of unaccompanied minors (UAMs), where caregiver involvement is not feasible, due to specific circumstances in accommodation centers and Supportin Greece.

BEHAVIORAL

Treatment as Usual (TAU)

The Treatment as Usual (TAU) approach involves routine clinical management and psychological support, without the use of a structured therapeutic framework. This intervention consists of general, non-specific support provided by clinical staff, including informal counseling and monitoring of the child's psychological well-being. Unlike more structured therapeutic protocols, TAU does not follow a predefined set of interventions or techniques, allowing for a flexible and individualized approach, though lacking the formal therapeutic focus of interventions like TF-CBT.

Locations (1)

General Secretariat for Vulnerable Persons and Institutional Protection, Ministry of Migration and Asylum
Athens, Greece