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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Trauma - Focused Cognitive Behavioral Therapy
BehavioralTF-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.
Treatment as Usual (TAU)
BehavioralThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Child and Adolescent Trauma Screen (CATS)
A standardized measure used to assess trauma-related symptoms in children and adolescents. This tool is used as the primary outcome to evaluate changes in trauma symptoms following the intervention.
Secondary outcomes
DASS-21: Depression, Anxiety, and Stress Scale
A 21-item scale used to assess levels of depression, anxiety, and stress. It serves as a secondary outcome to measure emotional distress in participants.
Strengths and Difficulties Questionnaire (SDQ)
A behavioral screening tool for children and adolescents that measures emotional symptoms, conduct problems, hyperactivity, peer relationship problems, and prosocial behavior. This will be used to assess general mental health and behavior.
PHQ-15: Physical Health Questionnaire
A questionnaire that measures physical symptoms related to health conditions. It will help evaluate any physical health-related outcomes from the intervention.
WHO-5 Well-Being Index
A 5-item index used to measure subjective well-being. This tool will assess overall psychological well-being and life satisfaction as a secondary outcome.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Theodora Anastasiou
Lead sponsor
Panteion University
Sponsor institution
Greek Ministry of Migration and Asylum
Collaborator
SOS Children's Villages
Collaborator