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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-18
SponsorTheodora Anastasiou

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

Qualifiers

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

Treatments tested in this trial

  • Trauma - Focused Cognitive Behavioral Therapy
  • Treatment as Usual (TAU)

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Theodora Anastasiou

Lead sponsor

Panteion University

Sponsor institution

Greek Ministry of Migration and Asylum

Collaborator

SOS Children's Villages

Collaborator